Boston, Mass, USA and London, UK, June 29, 2018 / B3C newswire / -- Orchard Therapeutics, a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today announced the appointment of Jim Geraghty as chairman of its board of directors. Ben Auspitz, a partner at F-Prime Capital, who served as Orchard’s chairman since 2016, will transition from his current role on the board.

“Orchard is privileged to have Jim join its board of directors at this crucial phase in the company’s lifecycle, given his unique experience and insights in building a global organization over the long-term,” said Ben Auspitz. “At Genzyme, Jim played an important role in the company’s transformation from a start-up with a strong technology base in the 1980s to a leading global rare disease company. Orchard has the potential to undergo a similar transformation as a leader of the gene therapy revolution and will greatly benefit from Jim’s experience.”

Jim Geraghty is an industry leader with over 30 years of strategic experience including more than 20 years as a senior executive at biotechnology companies developing and commercializing innovative therapies. Over his career, Jim served as senior vice president, North America strategy and business development at Sanofi, and previously as senior vice president international development at Genzyme, president of Genzyme Europe, and founding president and CEO of Genzyme Transgenics. Mr. Geraghty is chairman for the boards of Idera, Pieris and Juniper Pharmaceuticals, and is a member of the board of Voyager Therapeutics. He was most recently an entrepreneur in residence at Third Rock Ventures. Mr. Geraghty started his career in healthcare strategy consulting at Bain. A graduate of Yale Law School, Mr. Geraghty also holds a Master of Science degree from the University of Pennsylvania and a Bachelor of Arts degree from Georgetown University.

Jim Geraghty commented, “I am excited to be joining Orchard Therapeutics, an emerging leader in gene therapy for rare diseases. The company’s autologous ex vivo gene therapy technology is poised to change the practice of medicine across many indications, and I look forward to working with the executive team and other board members to help Orchard build a leadership position in the research, development and commercialization of gene therapies.”

Mark Rothera, Orchard’s president and CEO stated, “We are delighted to welcome Jim as chair of our board of directors. Jim’s advice and leadership will be invaluable as we continue to make progress towards being a global, fully integrated company transforming the lives of patients with rare diseases through gene therapy. I would also like to thank Ben for his commitment and guidance since the company’s formation. His insights have been a key ingredient of our success during our formative years and through our previous financing rounds.”

 
About Orchard
Orchard Therapeutics is a leading global fully integrated commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Evolved from over 20 years of academic research, Orchard has developed a unique expertise in the manufacturing, preclinical and clinical development of gene therapies for rare diseases. To date, more than 130 patients have been treated with autologous ex vivo gene therapy across five different disease areas, with evidence of sustained clinical effects up to 17 years post treatment in some patients. The company’s most advanced clinical program, OTL-101 for ADA-SCID (adenosine deaminase severe combined immunodeficiency), is expected to progress to a BLA (biological license application) with the FDA in 2018.

Orchard’s portfolio of autologous ex vivo gene therapy programs include Strimvelis, the first autologous ex vivo gene therapy approved by the EMA in 2016, three programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott–Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline.

The company is partnered with world-leading institutions in gene therapy, including University College London, Great Ormond Street Hospital, the University of Manchester and Central Manchester University Hospitals, the University of California Los Angeles, Boston Children’s Hospital, and Telethon Institute for Gene Therapy/Ospedale San Raffaele.

Orchard is privately held with offices in the UK and the US, including London, San Francisco and Boston. The company raised $110 million in a Series B in December 2017, was named a Fierce 15 Company by FierceBiotech in 2016 and was awarded a $19 million grant from the California Institute of Regenerative Medicine (CIRM).

 
Contacts

Corporate contact
Mary D. Wallace
Orchard Therapeutics
781-608-3666
Mary.Wallace@orchard-tx.com

Media contact
Allison Blum, Ph.D.
LifeSci Public Relations
+1 516 655 0842
Allison@lifescipublicrelations.com

York, UK, June 29, 2018 / B3C newswire / -- Rapidly growing biotech business, Aptamer Group Ltd, has closed its Series A investment round after attracting international interest, securing $2.2m of funding from overseas investors to support its pioneering aptamer development programme.

The funding will enable the expansion of the York Science Park-based business, creating ten new positions in technical, sales and administration roles which will support its continuous growth.

The Company is a key player in the global aptamer market, specialising in identification, development and characterisation of nucleic acid aptamers - a synthetic alternative to antibodies - which are fast becoming alternatives to traditional antibody approaches – replacing or filling the current gap in the antibody market.

Aptamer Group was founded in 2008 by Chief Executive Officer, Dr Arron Tolley and Chief Technical Officer, Dr David Bunka, who lead the now 16-strong team serving a global customer base of more than 50 organisations and has several of the top ten global Pharma companies as its customer base. The business operates four separate companies under the Aptamer Group ‘umbrella’ and has recently added an office in Boston (United States) where the aptamer market is growing rapidly.

Chief Executive Officer, Dr Arron Tolley says: “Aptamer technology is rapidly evolving and will have a significant effect on the life sciences market in the coming years due to our ability to rapidly discover aptamers - combined with advantages in the manufacturing process such as the stability of aptamers, the cost of manufacturing and the reproducibility of results when compared to antibodies. The investment will allow us to drive forward our pre-clinical discovery programmes involving the development of aptamer drug conjugates (ApDCs) which are set to become a revolutionary approach to targeted drug delivery.”

The funding round was supported by Netherlands-based biopharmaceutical investment company, Meneldor - founded by Dutch entrepreneurs Frans van Dalen and Paul Lelieveld. Frans is a founding partner of Synthon Holdings and has 30 years' experience in the development of New Biological Entities (NBEs) and Biosimilars. Paul is a serial investor and has invested in numerous early-stage life-science companies including Ablynx, which recently sold to Sanofi for $4.8bn.

Says Meneldor: “We believe that aptamer technology represents a paradigm shift in drug delivery methodology. We have invested in Aptamer Group Ltd due to their progressive approach and unique technology platform, which can select aptamers significantly better and faster with the superior binding properties.

We believe that this will lead to the development of new medicines and represents an exciting investment opportunity. We believe this company and its management team has the potential of becoming the next Ablynx”.

 
Contact

Hannah Trinder
The Partners Group
+44 (0)1904 610077
hannah@partners-group.co.uk

Clone 73-10 now available to the global research community

Cambridge, UK, July 02, 2018 / B3C newswire / -- Abcam, a global innovator in life science reagents and tools today announced the commercial launch of the new anti-PD-L1 antibody clone MKP1A07310 (clone 73-10) developed in collaboration with Merck KGaA, Darmstadt, Germany.

Developed by Abcam for use by Merck as an analytical antibody to support Merck’s therapeutic programme several years ago, this new clone has been created by Abcam’s in-house antibody engineers, who specialise in the discovery and development of challenging antibodies. The antibody is important in assessing the expression of PD-L1 in tumors from patients who might be able to benefit from PD-1/PD-L1 checkpoint immunotherapy.

John Baker, SVP Portfolio and Business Development, Abcam said: “Collaborations with industry partners are an important part of Abcam’s strategy to provide the best tools to all researchers world-wide. By working with Merck we are able to make available this important antibody at scale to help scientists accelerate their research, and expand understanding of the role of immune checkpoint inhibitors as cancer therapeutics.”

Clone 73-10 is an important addition to Abcam’s range of PD-1/PD-L1 immune checkpoint antibodies and is available via the Abcam website. To find out more please visit www.abcam.com/pdl1-ab-73-10.

About Abcam
As an innovator in reagents and tools, Abcam’s purpose is to serve life science researchers globally to achieve their mission, faster. Providing the research and clinical communities with tools and scientific support, the Company offers highly validated biological binders and assays to address important targets in critical biological pathways.

Already a pioneer in data sharing and ecommerce in the life sciences, Abcam’s ambition is to be the most influential company in life sciences by helping advance global understanding of biology and causes of disease, which, in turn, will drive new treatments and improved health.

Two-thirds of the world’s 750,000 life science researchers use Abcam’s affinity binders, reagents, biomarkers and assays and the Company’s products are mentioned in over 20,000 of the 56,000 peer-reviewed papers published each year in the life sciences.

By actively listening to and collaborating with researchers, the Company continuously advances its portfolio to address their needs. A transparent programme of customer reviews and datasheets, combined with an industry-leading validation initiative, gives researchers increased confidence in their results.

Abcam’s eleven locations are in the world’s leading life science research hubs, enabling local services and multi-language support. Founded in 1998 and headquartered in Cambridge, UK, the Company sells to more than 100 countries. Abcam was admitted to AIM in 2005 (AIM: ABC).

Contacts

Abcam
Francesca Axe
+44 1223 696000

Media enquiries
Dr. Lynne Trowbridge / Tim Watson, Instinctif Partners
+44 20 7866 7861
abcam@instinctif.com

Funding enables clinical stage trials of lead compound PseudoXa

• € 7.5 million Series A financing from lead investor BioGeneration Ventures (BGV) and Dutch regional development company InnovationQuarter
• Financing supplemented by € 5.0 million innovation credit from the Netherlands Enterprise Agency (RVO.nl)
• Leading compound addresses high unmet need for effective prevention and treatment of severe bleeding in the growing number of patients taking anti-coagulants
• Funding enables VarmX to significantly speed up the development of the lead compound and progress to clinical trials.

Leiden, The Netherlands, July 02, 2018 / B3C newswire / -- VarmX, Leiden based biotech company focusing on the development of therapies in the field of hemostasis and thrombosis, today announced the closing of a Series A financing round of € 7.5 million. The round was led by the existing shareholder BioGeneration Ventures (BGV) and regional economic development company InnovationQuarter also invested. Uniiq and Leiden University are also shareholders through conversion of their start-up loan to the company. The equity financing is supplemented by the Netherlands Enterprise Agency (RVO.nl) with an Innovation Credit of € 5.0 million to a total of € 12.5 million. The series A round is a follow up to the initial seed financing in June 2017 by BGV and Innovation Quarter. This news was announced this weekend at HollandBIO’s Dutch Biotech Event.

VarmX is developing lead compound PseudoXa to stop or prevent bleeding in patients taking anti-coagulants in the form of synthetic factor Xa inhibitors.  The product is based on the innovative research into the properties of a snake venom and of human factor X performed at the Leiden University Medical Center (LUMC). The new financing will enable VarmX to advance its lead compound PseudoXa as a safe and effective factor Xa anti-coagulant reversal agent into human clinical studies.

To avoid stroke or deep vein thrombosis, millions of patients worldwide daily take synthetic factor Xa inhibitors, such as apixaban, edoxaban or rivaroxaban, and the use of these drugs is increasing rapidly. As a side-effect, each year 2-3 % of patients taking these anti-coagulant drugs experience severe (internal) bleeding which is difficult to treat or to prevent in the setting of emergency surgery. PseudoXa offers a safe and effective solution to this bleeding problem by its capacity to immediately restore blood coagulation in the presence of factor Xa anti-coagulants.

Investors

With their Series A investment, following last year’s seed investment, BGV and InnovationQuarter together with RVO.nl enable the company expand its team and develop the production process, focusing on purification and formulation as well as on the pharmacodynamics and kinetics of the active compound. Moreover, safety in preclinical models and in human volunteers will be demonstrated. Work will also continue on the development of new compounds, to build VarmX into a biotechnology company with a broader pipeline of hemostasis and thrombosis related therapies.

Paul Bilars, CEO of VarmX and Professor Pieter Reitsma, emeritus of Molecular and Experimental Medicine at LUMC and CSO of VarmX, are excited about the prospect of bringing this drug to the market: “We are delighted with the trust of our shareholders, and also with the support that RVO.nl provides for our groundbreaking innovation. This meaningful funding allows VarmX to accelerate the development of PseudoXa and thus achieve our ultimate goal: to get our leading therapy treating severe bleeding in patients using anti-coagulants to the patient as quickly as possible. Our innovation is an important solution for another unmet medical need with which we try to make a difference for patients and their quality of life.”

Francis Quint, Head of InnovationQuarter Capital, states: “We are very satisfied with the good results VarmX reached during the last year and are pleased to again support this LUMC spin off to bring the development of PseudoXa to the next phase, the first clinical trials. Together with BGV and RVO we can give VarmX the opportunity to fully focus on the development of their promising compound, that address the significant unmet needs in the field of anti-coagulants.”

Oskar Slotboom, partner at BGV and chairman of VarmX comments: “We are pleased to lead this investment round to enable VarmX to demonstrate the safety and effectiveness of PseudoXa in clinical trials. Addressing such an unmet need for patients by applying differentiating innovative approaches is at the center of BGV’s investment strategy.”

Caption: VarmX's CEO Paul Bilars (middle left) and CSO Prof. Pieter Reitsma (middle right) show the tumbstone for their new €12.5 mln financing at the HollandBIO Dutch Biotech Event this weekend. On their left side from left to right presenter Hans Schikan, René Brama and Gerty Holla (InnvovationQuarter) and to the right, Francis Quint (InnovationQuarter), Elisabeth Schless of Rvo and Colja Laane on behalf of InnovationQuarter. 
Photo: Nils van Houts

For high resolution please click the image.

 
About VarmX
VarmX is a pharmaceutical spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. CEO is Paul Bilars, former managing director of one of LUMC’s divisions. In this capacity, he was also responsible for valorization of IP and strategic sourcing.
Product development is based on R&D performed by one of the world’s leading groups in hemostasis and thrombosis at the Leiden University Medical Center (LUMC), led by professor Reitsma.

The company’s leading product in development, PseudoXa, is a new therapeutic protein, based on the innovative research into the properties of a snake venom, to prevent or stop severe bleeding in patients taking factor Xa inhibitors, such as the commonly used apixaban.

About BioGeneration Ventures (BGV)
BioGeneration Ventures (BGV) is a specialist life sciences venture capital firm, with a focus on early stage European biotech, medtech, and diagnostics companies. BGV has a strong track record of significant financial returns through investing in innovations in healthcare and providing the expertise to build world-class teams. BGV manages funds investing in areas where the science, the unmet medical need, and the potential to promptly demonstrate a significant proof of concept all come together.
Successful investments include divestment of Dezima Pharma to Amgen for up to USD 1.55 billion in total deal value and in Acerta Pharma for up to USD 7 billion with a guaranteed payment of USD 4 billion. In both companies BGV was founding investor. The Acerta Pharma sale was the largest exit ever of a privately held European biotech company. Over the last decade BGV has made over 20 investments.
BGV is based in Naarden, The Netherlands, and closely collaborates with Forbion.

About InnovationQuarter
InnovationQuarter is the regional development agency for West Holland. InnovationQuarter finances innovative and fast-growing companies, assists international companies in establishing their businesses in West Holland, and facilitates (international) collaboration between innovative entrepreneurs, knowledge institutes and government. In this way, and in cooperation with the business community, InnovationQuarter supports the development of West Holland to become one of the most innovative regions in Europe.

InnovationQuarter Capital - which currently consists of € 135 million committed capital - offers venture capital to young technology companies and SMEs with growth plans in the region to bring new innovations to market. Through the fund, InnovationQuarter can raise the regional economy to a higher level.

InnovationQuarter is an initiative of the Ministry of Economic Affairs, the Province of South Holland, the Cities of Rotterdam, The Hague, Leiden, Delft, Drechtsteden, Westland and Zoetermeer, Delft University of Technology (TU Delft), Leiden University, the Leiden University Medical Center and Erasmus Medical Centre and Foundation HEID (Holding Fund for Economic Investment The Hague).

About UNIIQ
UNIIQ is a € 22 million investment fund investing in the proof-of-concept phase in innovative (bio)technology companies which are located in the South-Holland province. UNIIQ offers seed capital to entrepreneurs, offering them the capital for technology- and market validation and fund the initial high-risk proof-of-concept phase.

The fund is founded by Erasmus University Medical Center, Delft University of Technology, Leiden University and regional development agency InnovationQuarter. UNIIQ is supported by the European Union, the province of South-Holland and the municipalities of Rotterdam, The Hague and Leiden. InnovationQuarter performs the Fund management for UNIIQ.

 
Contacts

VarmX
Paul Bilars, CEO VarmX B.V.
T: +31715156127
M: +31610202593
p.bilars@varmx.com
www.varmx.com

Pieter Reitsma, CSO VarmX B.V.
T: +31715156127
M: +31651028841
p.h.reitsma@varmx.com

For media inquiries
LifeSpring Life Sciences & Health Communications, Amsterdam
Leon Melens
+31 6 538 16427
lmelens@lifespring.nl

Boston, USA and London, UK, July 09, 2018 / B3C newswire / -- Orchard Therapeutics, a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today announced the appointment of Joanne Beck, Ph.D., to its board of directors. Dr. Beck is currently the executive vice president of pharmaceutical development and operations and a member of the executive committee at Celgene.

Mark Rothera, president and CEO of Orchard said, “We are thrilled to have Joanne join our board. Her extensive experience in pharmaceutical development, global manufacturing operations and quality will serve our company very well as we accelerate our plans to implement a global supply chain of transformative gene therapies.”

Prior to Celgene, Dr. Beck was senior vice president of pharmaceutical development at Shire from 2012 to 2016. Before Shire, she held various leadership positions in Abbott’s global pharmaceutical operations and was the site head of Abbott Vascular Instruments GmbH. Earlier in her career, Dr. Beck held positions in process development at Genentech and Amgen. She holds a Bachelor of Arts degree from Lewis and Clark College and a Ph.D. from the University of Oregon Medical School.                                                                                                   

Dr. Beck commented, “I am pleased to be joining Orchard’s board of directors at such a pivotal time in the company’s development. I look forward to working with the board and leadership team as Orchard implements a global supply chain that delivers personalized gene therapies to patients.”

 
About Orchard
Orchard Therapeutics is a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Evolved from over 20 years of academic research, Orchard has developed a unique expertise in the manufacturing, preclinical and clinical development of gene therapies for rare diseases. To date, more than 130 patients have been treated with autologous ex vivo gene therapy across five different disease areas, with evidence of sustained clinical effects up to 17 years post treatment in some patients. The company’s most advanced clinical program, OTL-101 for ADA-SCID (adenosine deaminase severe combined immunodeficiency), is expected to progress to a BLA (biological license application) with the FDA in 2018.

Orchard’s portfolio of autologous ex vivo gene therapy programs include Strimvelis, the first autologous ex vivo gene therapy approved by the EMA in 2016, three programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott–Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline.

The company is partnered with world-leading institutions in gene therapy, including University College London, Great Ormond Street Hospital, the University of Manchester and Central Manchester University Hospitals, the University of California Los Angeles, Boston Children’s Hospital, and Telethon Institute for Gene Therapy/Ospedale San Raffaele.

Orchard is privately held with offices in the UK and the US, including London, San Francisco and Boston. The company raised $110 million in a Series B in December 2017, was named a Fierce 15 Company by FierceBiotech in 2016 and was awarded a $19 million grant from the California Institute of Regenerative Medicine (CIRM).

 
Contacts

Corporate contact
Mary D. Wallace
Orchard Therapeutics
781-608-3666
Mary.Wallace@orchard-tx.com

Media contact
Allison Blum, Ph.D.
LifeSci Public Relations
+1 516 655 0842
Allison@lifescipublicrelations.com

Berlin, Germany, and San Francisco, CA, USA, July 10, 2018 / B3C newswire / -- ProBioGen AG, a premier service and technology provider for complex therapeutic glycoproteins, and Pionyr Immunotherapeutics, an immuno-oncology company which develops next generation antibody-based therapeutics that target the tumor microenvironment, today announced a second service and license agreement to develop novel antibody therapeutics. Under the terms of the agreement, ProBioGen will perform process development and GMP manufacturing on a second antibody from the Pionyr pipeline using their high performance CHO.RiGHT® expression platform. Parallel cell line development and analysis will allow for optimal cell line selection while compressing the development timeline, enabling a rapid advance to clinical trials.

“We developed a strong collaboration with Pionyr Immunotherapeutics on their initial antibody candidate, and we are enthusiastic about advancing a second antibody candidate into development. We consider Pionyr’s Myeloid Tuning™ approach to be ideally suited to target solid tumors and look forward to contributing to multiple programs with our CHO.RiGHT® development and manufacturing platform. We have established a seamless team working across the two companies and are very pleased to expand our collaboration”, said Dr René Brecht, VP Process Science and Manufacturing.

Evan Greger, Pionyr VP of Process Development and CMC, added, “Pionyr is developing a novel class of antibody-based therapeutics that can alter the tumor microenvironment to favor immune-activating cells over immune-suppressing cells. After establishing a collaboration with ProBioGen in 2017 to advance our first Myeloid Tuning™ candidate into cell line development and clinical trials, we are enthusiastic to continue our partnership and advance a second antibody candidate. ProBioGen is an outstanding partner with well-respected development and manufacturing services. The CHO.RiGHT® expression platform, combined with their experienced, committed team, is ideally suited for the rapid and successful advancement of our antibody programs into clinical trials.”

 
About ProBioGen AG
ProBioGen is a premier, Berlin-based specialist for development and manufacturing of complex therapeutic glycoproteins. Combining both state-of-the-art development platforms, based on its CHO.RIGHT^® expression and manufacturing platform, together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA). ProBioGen was founded in 1994, is privately owned, and is located in Berlin, Germany.

About Pionyr Immunotherapeutics Inc.
Pionyr Immunotherapeutics (formerly Precision Immune Inc.), located in San Francisco, California, USA, is developing cancer immunotherapies that target the tumor microenvironment to enhance the body's antitumor immunity. The company is exploiting novel target discovery and antibody generation platform technologies to create a next generation of immuno-oncology therapeutics. The company's approach, Myeloid Tuning™, is designed to enhance the immune system's anti-tumor response by altering the cellular infiltrate of the tumor microenvironment with high specificity. Pionyr’s Myeloid Tuning™ technology is based on the discovery that altering the tumor microenvironment to favor immune-activating cells over immune-suppressing cells enhances the body’s ability to combat cancer.

 
Contacts

ProBioGen AG
Dr Gabriele Schneider
Chief Business Officer
ProBioGen AG
Goethestr. 54
13086 Berlin, Germany
+49 (0)30 924 006-0
cmo@probiogen.de
www.probiogen.de

Pionyr Immunotherapeutics
Evan Greger
Vice President, Process Development and CMC
Pionyr Immunotherapeutics Inc.
953 Indiana Street
San Francisco, CA 94107
+1 415 226 7503
info@pionyrtx.com
www.pionyrtx.com

• Immatics and Genmab to Combine Proprietary Technologies to Create Transformative Bispecific Therapies against Novel, Proprietary Tumor Targets
• Immatics to Receive $54 Million Upfront, Milestone Payments Plus Royalties and an Option to Co-Promote the Partnership Products

Tuebingen, Germany, July 12, 2018 / B3C newswire / -- Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting cancer immunotherapies, announced today that it has entered into a research collaboration and license agreement with Genmab A/S (Nasdaq Copenhagen: GEN) to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancer indications.

The companies will conduct joint research, funded by Genmab, to combine Immatics’ XPRESIDENT® and Bispecific TCR technology platforms with Genmab’s proprietary antibody technologies to develop multiple bispecific immunotherapies in oncology. The companies will exclusively discover and develop immunotherapies directed against three proprietary targets, which were discovered and developed by Immatics’ XPRESIDENT® technology. Genmab has the option to exclusively license up to two additional targets to expand the partnership at predetermined economics.

Genmab will be responsible for development, manufacturing and worldwide commercialization. Immatics will have an option to contribute certain promotion efforts at predetermined levels in selected countries in the EU.

Under the terms of the agreement, Immatics will receive an upfront fee of $54 million and is eligible to receive up to $550 million in development, regulatory and commercial milestone payments for each product and tiered royalties up to a double-digit percentage of net sales.

Carsten Reinhardt, M.D., Ph.D., Chief Medical Officer and Managing Director of Immatics, commented: “We are very pleased to join forces with one of the world-leading biotechnology companies to develop and advance novel and highly active cancer therapeutics. This collaboration underpins Immatics’ leadership in intracellular tumor target identification and T-cell receptor engineering.” Dr. Reinhardt further said: “Our bispecific TCR technology exhibits exceptional potency and favourable pharmacokinetic properties by combining Immatics’ proprietary T-cell engaging format with our high-affinity and highly specific T-cell receptors as reported at AACR 2018.(1)”

“This collaboration with Immatics gives us the opportunity to combine our unique technologies and expertise to create differentiated novel next-generation therapies. We very much look forward to this exciting partnership in the field of cancer immunotherapy,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About Immatics’ Bispecific TCR Technology
Bispecific T-cell receptor (TCR) molecules are biologics that leverage the body’s immune system by redirecting and activating the T-cell response towards cancer cells expressing specific tumor targets. Immatics’ best-in-class bispecific TCR molecules are soluble fusion proteins that have two binding domains: an affinity-maturated and highly selective TCR domain that recognizes and binds to a tumor-specific peptide target presented in the context of HLA class I receptor, and a T-cell recruiting antibody domain directed against CD3 or other immuno-modulating T-cell surface proteins. The design of these novel biologics allows T cells to become activated and attack the tumor, regardless of the T cells’ intrinsic specificity.

About Immatics
Immatics is a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting immunotherapies for the treatment of cancer. The Companies’ transformative product candidates are ‒ best in class ‒ Adoptive Cell Therapies and Bispecific TCR molecules. These products are directed against tumor targets that have been identified and validated by Immatics’ proprietary and world-leading XPRESIDENT® technology. XPRESIDENT® is the most sensitive, unbiased and high-throughput technology capable of identifying targets in virtually any type of cancer and any HLA type. Together with Immatics’ powerful TCR discovery technology, these two platforms allow a full range of cancer therapies to be developed.

Immatics’ pipeline includes T-cell therapy programs based on the proprietary ACTolog®, ACTengine® and ACTallo® approaches, which are developed in collaboration through Immatics US with University of Texas MD Anderson Cancer Center and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT), and several bispecific TCR and antibody molecules.

Operating from Tuebingen, Munich and Houston, the Company has recognized that novel, better and safer targets are the key to developing future cancer immunotherapies and it is Immatics’ mission to deliver the power of T cells to cancer patients.

About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.  Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications.  Daratumumab is in clinical development for additional multiple myeloma indications and other blood cancers.  A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis.  Genmab also has a broad clinical and pre-clinical product pipeline.  Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies.  The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies.

 
Contact

Immatics Biotechnologies GmbH
Dr. Nikola Wiegeler                                                                                                             
+49 7071 5397-110
media@immatics.com

(1)  Bunk S, et al. Development of highly potent T-cell receptor bispecifics with picomolar activity against tumor-specific HLA ligands [abstract]. In: Proceedings of the 109^th Annual Meeting of the American Association for Cancer Research; 2018 Apr 14–18; Chicago, IL. Abstract nr 2789.

New investors Omnes, BNP Paribas Développement and Sham Innovation Santé invest an additional €5.2M on top of the €7.3M first closing announced in October 2017

Labège, France, July 12, 2018 / B3C newswire / -- Antabio SAS, a biopharmaceutical company developing novel antibacterial treatments in areas of highest unmet needs, announced today it has extended its Series A financing round with an additional €5.2 million subscribed by investment funds Omnes, BNP Paribas Développement, and Sham Innovation Santé (Turenne Capital). Existing shareholder Galia Gestion also participated in this extension. In October 2017, Antabio announced a first closing of its Series A financing round for €7.3 million subscribed by investment funds iXO Private Equity, IRDI SORIDEC Gestion, Galia Gestion and Antabio’s historical investor and former President of OM Pharma Christophe Ricard. The second closing brings the total raised in Series A to €12.5 million.

The new funding will be used to accelerate the development of Antabio’s novel inhibitor of bacterial metallo ß-lactamases (“MBLs”) which will be combined with a carbapenem to fill an important gap in the treatment of drug-resistant infections. Superbugs carrying MBLs (such as NDM-1) are spreading worldwide and cause life-threatening drug-resistant infections that are deemed a critical medical priority by the WHO. There are currently no marketed inhibitors of MBLs.

The €12.5 million series A financing complements the CARB-X grant of up to $8.9 million awarded to Antabio in July 2017 to support the company’s Pseudomonas Elastase Inhibitor program (PEI) for the treatment of chronic Pseudomonas infections in Cystic Fibrosis patients.

“We are thrilled to welcome Omnes, BNP Paribas Développement, and Sham Innovation Santé to Antabio,” said Marc Lemonnier, CEO of Antabio. “We have built a strong international team of experts to combat the most urgent unmet medical needs in the antibacterial space. This extension to our series A, coupled with the substantial non-dilutive funding received from CARB-X, provides solid financial means for Antabio to take our innovative program into the clinic and move closer to this goal”.

Antibiotic resistance is a growing global health problem recognized as n°1 priority by the WHO. Today, 5 to 10% of hospital patients in the USA and Europe develop a hospital-acquired (nosocomial) infection with over 100,000 deaths due to drug-resistant bacterial infections per year and annual costs to public health exceeding €30 billion. On the horizon, alarming reports claim that by 2050 antimicrobial resistance will kill more people than cancer with an estimated 10 million people dying from resistant infections each year.

"Antibiotic resistance is one of the great challenges of our time. At Omnes, we were impressed by the innovative approach taken by the company to fight drug-resistant infections and we are delighted to support their strong international team to accelerate the development of their programs to the clinic" said Claire Poulard, Associate at Omnes.

About Omnes
Omnes is a leading Paris-based European investor in private equity and infrastructure. With €3.6 billion of assets under management, Omnes provides SMEs with the capital needed to finance growth. The firm has dedicated investment teams across three key areas: Venture Capital, Buyout & Growth Capital and Infrastructure. With more than 30 trade sales and nearly 15 IPOs in 19 years (including Novaled, Biovex, arGEN-X and Direct Energie), Omnes’ venture team is a leading French player in financing innovative SMEs with dual expertise in the deep-tech and healthcare sectors. Omnes is owned by its employees. Omnes is committed to ESG issues and has set up the Omnes Foundation in aid of children’s charities. It is also a signatory to the United Nations Principles for Responsible Investment (PRI). More information on www.omnescapital.com
Press contacts
Omnes Capital : Gaëlle de Montoussé, gaelle.demontousse@omnescapital.com – +33 1 80 48 79 16
Brackendale Consulting: Fay Margo, fay@brackendaleconsulting.com - +44 7962115825

About BNP Paribas Développement
BNP Paribas Développement, a BNP Paribas Group subsidiary founded in 1988, invests its own capital directly in promising small and medium-sized enterprises and mid-cap companies.  As a minority shareholder in these target companies, BNP Paribas Développement seeks to promote their growth and ensure their longer-term prosperity by facilitating ownership transfer.

In addition to providing financial resources so as to ensure the stability of any company in which BNP Paribas Développement invests, we also see our mission in helping the company management team to achieve its medium-term strategic plans.  As a minority shareholder, our approach is to assist our partner with an appropriate level of governance, based on our experience of managing a portfolio of some 300 company shareholdings and backed by the strength of a world-class financial group, but without interfering in the day-to-day running of the partner company.  Our policy of investing our own capital allows us to provide our partner companies with long-term backing suited to the nature of the particular business and its goals, and also enables us to act as an intermediary in such deals as capital re-organisations and external growth operations. In 2016, BNP Paribas Développement set up the WAI Venture Fund, which specialises in investing in Innovation-oriented companies, from the provision of seed capital through all subsequent funding rounds, with the aim of supporting the growth of high-potential startups.
Press contact: Olivier Durbize, olivier.durbize@bnpparibas.com - +33 1 40 14 66 28. More information on www.bnpparibasdeveloppement.com

About Sham Innovation Santé
Launched in July 2014, Sham Innovation Santé is an evergreen Venture Capital Fund controlled and owned by Sham, a French mutual insurance company specializing in insurance and risk management for professionals in the health, social and social-medical sectors and a French leader in civil liability (11,000 members in Europe – France, Italy, Spain, Germany –, € 2 billion in assets under management, 952 employees, revenues of € 438.2 million in 2018).
Advised and managed by Turenne Capital, Sham Innovation Santé invests into biotech and medtech companies that are developing breakthrough technologies in the medical and biotechnology fields. The portfolio – 12 companies – is being gradually built up by new investments in the healthcare and life sciences field, with a target of € 50 million.
Press contact: Josépha Montana, jmontana@turennecapital.com - +33 6 01 21 21 49. More information on  www.sham.fr |  www.turennecapital.com

About ANTABIO
Antabio is a private biopharmaceutical company developing novel antibacterial resistance-breakers to treat drug-resistant infections in areas of highest unmet medical need. Two of Antabio’s programs have received Wellcome Trust Seeding Drug Discovery Awards to date:(i) a novel, safe and efficacious inhibitor of bacterial metallo ß-lactamases to be combined with a carbapenem for the treatment of drug-resistant nosocomial infections and (ii) a first-in-class inhibitor of Pseudomonas virulence to be co-administered with standard-of-care antibiotics for the long-term management of chronic respiratory infections. This second program has recently received up to $8.9 million funding from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The company’s lead product is expected to enter the clinic in 2019 with anticipated fast track approval. Antabio has built a best in class, international team of experts in the field to progress its pipeline. The Company is in the process of acquiring additional assets focused on Gram-negative antibiotic resistant therapies.
Press contact: Carine Bonnet-Danaire, press@antabio.com - +33 5 31 47 18 57. More information on www.antabio.com and follow us on Twitter @antabio 

Munich, Germany, July 17, 2018 / B3C newswire / -- leon-nanodrugs GmbH (“leon”) is pleased to announce that its proprietary MicroJet Reactor (MJR®) nano-technology has been selected by Takeda Pharmaceutical Company Ltd. (Takeda) for a feasibility assessment that could potentially lead to the development of an innovative formulation of one of their current pipeline products.

leon-nanodrugs announced that the company has started a feasibility assessment collaboration with Takeda. Under this collaboration, leon will support Takeda`s formulation efforts to optimize solubility, bioavailability and stability for one of Takeda’s current pipeline products for drug delivery using leon’s proprietary nanotechnology platform –MicroJet Reactor (MJR®).

leon`s platform can be used from early compound screening to production of market batches. Positive results from this feasibility study could potentially result in a long-term collaboration between the companies, and additional compounds may also be considered.

It is estimated that over 60% of pharmaceutical API’s are poorly soluble in water.  leon’s MJR technology offers reformulation options that not only address this issue, but can also lead to a superior profile for the API by increasing bioavailability, reducing inter patient variability, improving onset of action, etc. The one-step, bottom up, continuous precipitation process approach of the MJR® technology is cost effective and easily scalable.

Dr. Michael Mehler, CEO of leon-nanodrugs GmbH comments: “We are very pleased and proud that Takeda selected our MJR® technology for a feasibility assessment with one of their compounds in development. It is a major milestone for our company to win Takeda, a globally leading pharmaceutical company, as a partner and we look forward to this collaboration with the goal to contributing to bring valuable new medicines to patients worldwide.”

About leon
leon-nanodrugs GmbH (Munich) is a nanotechnology-based drug development company focused on reformulations to develop novel oral and parenteral formulations and innovative drug combinations. Build on its “network of expertise”, leon-nanodrugs can provide a 360 degree service range – from concept to product approval. By using MJR®-technology leon took the technical leadership in the re-formulation market and is creating patient benefits and economical values to existing drugs. leon works with its Pharma customers through contract development agreements, as well as co-development partnerships. leon has also initiated work on its own internal development projects, concentrating on nanotechnology-based reformulations that offer enhanced clinical and safety benefits.

Contact

Dr. Michael Mehler
Chief Executive Officer
leon-nanodrugs GmbH
Kopernikusstrasse 9
D-81679 München
m.mehler@leon-nanodrugs.com

Lausanne, Switzerland and Palo Alto, USA, July 17, 2018 / B3C newswire / -- Polares Medical SA, a preclinical stage medical technology company focused on the development of a unique trans-catheter mitral valve hemi-replacement system to treat patients suffering from mitral regurgitation (MR), announced today the closing of a $25 million financing led by Decheng Capital (Menlo Park and Shanghai) together with Endeavour Vision (Geneva), IDO Investments (Muscat), Earlybird Venture Capital (Berlin) and Wellington Partners (Munich).

Polares Medical’s solution to MR is based on the original concept of hemi-replacement of the mitral valve, i.e. the replacement of the posterior leaflet with a prosthetic leaflet designed to enhance coaptation with the native anterior leaflet.

“Hemi-replacement represents a new treatment paradigm for mitral regurgitation, between repair and total replacement. We believe this approach has the potential to provide an effective addition to the armamentarium for the percutaneous treatment of MR,” said Decheng Principal Nick Pliam, MD, Ph.D.

Polares Medical was created as a spin-off of Symetis SA to develop the mitral technology that Symetis obtained through its acquisition of Middle Peak Medical GmbH, prior to Boston Scientific Corporation’s acquisition of Symetis in 2017. 

“This investment allows Polares to bring our technology to clinical evaluation, and to unleash its potential as a game-changer in MR treatment.” said Jacques Essinger, Ph.D, Chairman and CEO.

Contacts

Polares Medical SA
+41 21 310 11 20
info@polaresmedical.com
www.polaresmedical.com

Decheng
+1 (650) 233-0688
nick@decheng.com
www.decheng.com

Deqing, China, July 19, 2018 / B3C newswire / -- Following a 2016 accreditation of Shuwen Biotech’s central lab, Shuwen Guanz Diagnostic Lab Co., Ltd, Shuwen is proud to announce that it has successfully passed the 2018 biannual review and was awarded a two-year extension of the CAP accreditation.

Certification from The College of American Pathologists (CAP) is recognized as the global standard for laboratory quality management and technology in various international medical organizations, and has become the "gold standard" in the field of international laboratory medicine. Reports issued by CAP-certified laboratories meet US FDA requirements in the regulatory processes for new drugs to be marketed in the United States.

About Shuwen Biotech
Shuwen Biotech is a China-based diagnostic company founded on the principles of innovation, patent protection, and international collaboration as its strategic platforms for growth. Since 2011, Shuwen established strategic partnerships with numerous outstanding academic and commercial institutions such as Yale University, University of Chicago, BioNTech, Sphingotec among others in the form of exclusive licensing of first-in-class diagnostic technologies and patents covering a range of novel biomarkers for companion diagnostics and other diagnostics in the fields of cancer, women’s health, critical care, and health screening and other fields. Shuwen has also developed innovative and quality companion diagnostics and provided central lab testing services to leading pharmaceutical developers. Shuwen houses an in-house development team, CAP-accredited central labs, and ISO13485-certified IVD manufacturing facilities, all in line with global standards in order to continue to deliver transformational products and services to its customers globally and open new possibilities in the advancement of health.

Contact

Vafa Amirkia
bd@shuwendx.cn

Santa Monica, USA and Utrecht, the Netherlands, July 19, 2018 / B3C newswire / -- Kite, a Gilead Company (Nasdaq: GILD), and Gadeta B.V., a privately-held company focused on the discovery and development of novel cancer immunotherapies based on gamma delta T cell receptors (TCRs), have entered into a strategic collaboration to develop novel gamma delta TCR therapies in various cancers. Under the financial terms, Kite will provide research and development (R&D) funding for the collaboration and Gadeta will be eligible to receive future payments upon achievement of certain regulatory milestones.  In addition, Kite will make an upfront purchase of equity in Gadeta from Gadeta’s shareholders and may acquire additional equity in Gadeta upon achievement of certain R&D milestones. Kite will have the exclusive option to acquire Gadeta.

Gadeta has developed a proprietary technology to engineer alpha beta T cells with gamma delta TCRs, called TEGs, for the potential treatment of various hematological cancers and solid tumors. This platform has the potential to combine the advantages of conventional T cells, which express alpha and beta TCR chains, with TCRs derived from gamma delta T cells that recognize novel targets in cancer cells, according to preclinical models evaluating the lead TEG candidates. Unlike alpha beta T cells, gamma delta TCRs do not require expression of cell surface proteins (major histocompatibility complex (MHC) molecules) for target recognition, and their ability to recognize novel targets under stress or metabolic conditions offer an attractive approach to develop potentially effective cell therapies in solid tumors.

Gadeta was founded in 2015 by Professor Jürgen Kuball, Mark de Boer, Utrecht Holdings and Medicxi, its founding investor.

“We continue to invest in research approaches that support the development of innovative cell therapies for people living with cancer,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “We are excited to work with Gadeta on its gamma delta TCR technology. This research collaboration adds an additional new platform to our current capabilities in research and cell manufacturing, and deepens our commitment to develop novel approaches to treat solid tumors.”

“Our mission is to develop novel gamma delta TCR cell therapies that have the potential to benefit patients with cancer,” said Shelley Margetson, Gadeta’s Chief Executive Officer. “We are excited to gain the support of a leader in the cell therapy field, which has seen the potential of our platform and products to redefine cancer therapy.”

 
About Gadeta
Gadeta has developed a technology platform based on combinatorial T cell receptor exchange (CTE) to create optimized gamma delta T cell receptors (TCRs) with an enhanced anti-cancer reactivity. The platform is based on research from Prof. Jürgen Kuball from University Medical Center Utrecht (UMC Utrecht) and Chief Scientific Officer at Gadeta. Gadeta’s investigational cell-based anti-cancer products called T Cells Engineered To Express A Defined Gamma Delta TCR (TEGs) have therapeutic potential for combating and eradicating both hematological and solid tumors. This approach utilizes high-affinity gamma delta TCRs expressed on alpha beta T cells with enhanced proliferation capacity.

About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.

About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.  The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead and Kite Forward-Looking Statements
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Gilead and Kite may not realize the potential benefits of this collaboration with Gadeta or other investments in cell therapies.  All statements other than statements of historical fact are statements that could be deemed forward-looking statements.  These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the U.S. Securities and Exchange Commission.  All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

Contacts

Gilead/Kite
Sung Lee, Investors
+1 (650) 524-7792

Nathan Kaiser, Media
+1 (650) 522-1853

Gadeta
Shelley Margetson, CEO
+31 6 31 900 812

Hans Herklots (Media)
+41 79 598 7149

• Company to address unmet medical needs in the field of rare metabolic disorders
• Exclusive IP licensed from Leiden University and Amsterdam UMC
• Senior industry R&D leader Olivier Morand appointed as Chief Executive Officer and member of the Board of Directors
• BioGeneration Ventures founding investor

Leiden, The Netherlands, July 23, 2018 / B3C newswire / -- Azafaros, a biotech company established in Leiden in the Netherlands, focusing on the development of new therapies in the field of rare metabolic disorders, today announced the closing of a seed financing round. BioGeneration Ventures (BGV) is the founding investor.

Rare metabolic disorders such as lysosomal storage disorders (LSDs) represent a broad class of severe and sometimes life-threatening inherited diseases, presenting significant unmet medical needs, with only few approved therapies. With its proprietary small molecule compounds, Azafaros will concentrate on new treatments for patients suffering from LSDs and LSD-related diseases. These compounds interfere with the metabolism of glycolipids that is disturbed in these patients and are intended to counteract the underlying pathological effects.

Azafaros holds an exclusive license from Leiden University and Amsterdam UMC (location AMC) to a library of novel compounds and patents that were discovered by Professor Hans Aerts and his co-workers at Amsterdam UMC and Leiden University. Through a broad research collaboration Azafaros will benefit from the vast experience of the group led by Professor Hans Aerts to progress the technology.

Olivier Morand, Ph.D. and IMD alumnus, is joining Azafaros as Chief Executive Officer (CEO) and member of the Board of Directors. Olivier Morand, a senior leader in pharma strategic development for early- and late-phase products, brings many years of hand-on experience and know-how in rare metabolic disorders and orphan drugs. He has a very strong industry track record most recently at Idorsia Pharmaceuticals, and before that at Actelion Pharmaceuticals and Hoffmann-La Roche. In his early career, he held various roles in academic institutions such as INSERM Paris, the University of Wisconsin Madison, the Hadassah Medical School Jerusalem and the Mount Sinai Medical School New York. With this, Olivier Morand brings a broad scientific, clinical and regulatory experience as well as business insights to the Azafaros team.

Olivier Morand, CEO, says: “I feel very privileged to lead Azafaros. I anticipate that with our focused efforts the company will be able to develop high performing drugs out of the Leiden University and Amsterdam UMC compound library, supported by a solid patent position, and based on strong scientific rationale and sound clinical approaches.”

Edward van Wezel, managing partner at BGV and member of the Board of Directors, comments: “We are very excited to be able to support the development of new treatment modalities for LSDs with a founding team that has strong scientific and business experience in a field with clear unmet medical needs. We strongly believe that these new compounds have the potential to offer better clinical outcome for patients in the future.”

About Azafaros
Azafaros is a spin-off from Leiden University and Amsterdam UMC (location AMC). The company aims at developing therapeutic agents for the treatment of rare metabolic disorders such as lysosomal storage disorders through oral administration of aza-sugar compounds. These novel, very promising agents were discovered by Professor Hans Aerts at Leiden University and Amsterdam UMC and are exclusively licensed to Azafaros.

About BioGeneration Ventures
BioGeneration Ventures (BGV) is a specialized life sciences venture capital firm, with a focus on early stage European biotech, med-tech, and diagnostics companies. BGV has a strong track record of significant financial returns through investing in innovations in healthcare and providing the expertise to build world-class teams. BGV manages funds investing in areas where the science, the unmet medical need, and the potential to rapidly demonstrate a significant proof of concept all come together.

Successful investments include divestment of Dezima Pharma to Amgen for up to USD 1.55 billion in total deal value, and in Acerta Pharma for up to USD 7 billions. BGV was founding investor in both companies. The Acerta Pharma sale was the largest exit to date of a privately held European biotech company. Over the last decade BGV has made over 20 investments.

BGV is based in Naarden, The Netherlands, and closely collaborates with Forbion Capital Partners.

Contact

Azafaros B.V.
info@azafaros.com
+31 (0) 35 699 30 00
http://www.azafaros.com

Visiting address: J.H. Oortweg 21,
2333 CH Leiden, the Netherlands

Mailing address: Gooimeer 2-35,
1411 DC Naarden, The Netherlands

Posted by Sabine Duntze, B3C Group GmbH

San Ramon, CA, August 02, 2018 / B3C newswire / -- Abdi Ibrahim, the Turkish pharmaceutical industry leader, has carefully selected rfxcel to implement and support new compliance management and serialisation processing software to ensure full compliance with current and future international legislative requirements ahead of the 2019 EU Falsified Medicines Directive (FMD) deadline.

Abdi Ibrahim, founded in 1912, began as a small pharmacy that has since grown into the leader of Turkey’s pharmaceutical industry, holding the largest product portfolio within the sector and operating in 10 countries outside of Turkey. Today, Abdi Ibrahim’s portfolio exceeds 180 brands and more than 350 products which it exports to 50 countries ranging from Canada to the European Union member states, from North Africa to Asia.

With the February 2019 FMD deadline fast approaching, Abdi Ibrahim needed a solutions provider that would enable them to become compliant in time for the FMD deadline, but additionally would fulfil their need for new, modern technological operations with data integrity at their core.

After an in depth review, analysing several industry products and providers, Adbi Ibrahim selected rfxcel due to the solution’s rich functionality as well as the company’s Single Tenant private cloud deployment, its full-service implementation methodology, flexibility and speed and competitive pricing.

Rumeysa Tanrikulu, Information Systems Supervisor at Abdi Ibrahim explains, “It was really important for us to implement a software solution that was single-tenant rather than multi-tenant. rfxcel was one of the only single tenant providers that offered a bespoke service at a reasonable cost. What’s more, the team at rfxcel was direct, clear and extremely helpful, answering all the questions we threw at them.”

She adds, “The team was friendly and driven not by the sale, but by the benefit they could bring to the business. For us, given the weight of responsibility we feel we carry in improving the health of the population we serve, their company ethos was very much aligned to ours. So far, our relationship has been honest, collaborative and we have full visibility of the implementation process that will help ensure not only regulatory compliance, but a future-proof supply chain that is built upon the foundation of data quality.”

Adbi Ibrahim is currently mid-implementation with aims for the compliance management and serialisation processing software to be live during October 2018.

 
About rfxcel
rfxcel is a supply chain track, and trace company within the Life Sciences industry, helping companies meet regulatory compliance requirements, protect the product and ascertain brand reputation. Thought leadership and experience since 2003, expansions to locations in the US, EU, India, Brazil, and Japan, and a leading stand-alone traceability solution, the company, enables people, businesses, and industries to protect end consumers and their products. This unique integrated software delivers better business outcomes and lowers overall costs.

Find more information about how rfxcel is shaping the future of supply chain at https://www.rfxcel.com

Contact

Herb Wong
VP Marketing
hwong@rfxcel.com
rfxcel.com

Posted by Sabine Duntze, B3C Group GmbH

Boston, USA and London, UK, August 02, 2018 / B3C newswire / -- Orchard Therapeutics, a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today announced the appointment of Jon Ellis, Ph.D. as GSK’s designated representative to its board of directors. Dr. Ellis is currently vice president and head of science & technology licensing at GlaxoSmithKline (GSK).

“Jon brings a unique combination of business development expertise and deep understanding of emerging technologies in the field of gene and cell therapy. We believe Orchard will greatly benefit from his advice as the company continues to build a world-leading pipeline of gene therapies for rare diseases,” said Mark Rothera, president and CEO of Orchard.

Dr. Ellis brings more than 25 years in the pharmaceutical and biotech industry, leading a variety of R&D activities including drug development projects and strategic business development with a particular focus on complex technologies and emerging therapeutic modalities. At GSK, Dr. Ellis led several strategic transactions in the gene therapy field. Dr. Ellis holds Master of Arts and Ph.D. degrees from the University of Cambridge, and a Master of Business Administration from Henley Management College. He is an inventor of more than 35 patent families.

Dr. Ellis commented, “GSK conducted an exhaustive process to identify the best company to place its gene therapy programmes for rare diseases. Orchard impressed us with its commitment and capabilities. I am delighted to be joining Orchard’s board of directors and look forward to working with the board and executive team to deliver commercially approved gene therapies to patients across the world.”

 
About Orchard
Orchard Therapeutics is a commercial-stage biotechnology company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the EMA for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for primary immune deficiencies, inherited metabolic disorders and blood disorders include three advanced registrational studies for ADA-SCID, metachromatic leukodystrophy (MLD) and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and beta-thalassemia, as well as an extensive preclinical pipeline.  Orchard currently has offices in the U.K. and the U.S., including London, San Francisco and Boston.

Contacts

Corporate contact
Mary D. Wallace
Orchard Therapeutics
781-608-3666
Mary.Wallace@orchard-tx.com

Media contact
Allison Blum, Ph.D.
LifeSci Public Relations
+1 516 655 0842
Allison@lifescipublicrelations.com

Posted by Sabine Duntze, B3C Group GmbH

Odense, Denmark, August 07, 2018 / B3C newswire / -- RSP Systems A/S, the non-invasive diagnostics company, announces that it has received the ISO 13485:2016 certificate, demonstrating commitment to placing its non-invasive glucose meter for diabetes management on the market.

The process of implementing RSP System’s Quality Management System began in late 2016 with the building of a strong QA and Clinical Trial team. This effort has gradually strengthened, and the newly awarded certification is the achievement of the first important milestone for the program, which has the overall aim of yielding MDR compliance and European market approval in 2020 for RSP System’s glucose meter for diabetes management.

RSP System’s CEO, Andreas Jenne, added: ‘This is the first tangible result from a focused process, starting with putting a great team together, dedicating resources and now demonstrating the ability of the team to deliver. This bodes well for the overall success of our regulatory program.’

The ISO 13485 Certification follows on the heels of the recent Series B financing round, which to date has provided an additional €6.5 million of funding towards more in depth clinical trials, CE marking, and preparations for market launch.

 
About RSP Systems A/S
RSP Systems is a Danish biotechnology company founded in 2006 as a spinout from Odense University focused on using Raman spectroscopy for human diagnostics. Raman is a well-understood and widely applied technology, but its employment for human diagnostics has long eluded industry. RSP Systems has now taken the hurdles and offers the world’s first robust diagnostic system. Over the past 6 years, the company has aimed for glucose and has now developed a prototype which shows target performance in clinical studies on diabetic patients at the University of Odense. The company is now integrating its technology into a consumer device as the first non-invasive glucose monitor of analytical quality for diabetic patients. Other applications will follow the market launch.

Contact

Anders Weber, CSO
andersw@rspystems.com 

Posted by Sabine Duntze, B3C Group GmbH

Proceeds to advance three late-stage programs towards registration, prepare for commercialization and progress the company’s gene therapy platform

Boston, USA and London, UK, August 13, 2018 / B3C newswire / -- Orchard Therapeutics, a leading commercial-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today announced the completion of an oversubscribed $150 million Series C financing.

Deerfield Management led the financing with significant new investments from RA Capital Management, Venrock, Foresite Capital, Perceptive Advisors, Cormorant Asset Management LP, ArrowMark Partners, Sphera Global Healthcare, Medison Ventures, Driehaus Capital Management and Ghost Tree Capital Group, LP, as well as additional U.S. based healthcare focused funds. Existing investors also participated including Temasek, Baillie Gifford, RTW Investments, LP, Cowen Healthcare Investments and Agent Capital.

Proceeds from the Series C financing will be used to progress Orchard’s three most advanced clinical programs: OTL-101 for adenosine deaminase severe combined immunodeficiency (ADA-SCID), OTL-200 for metachromatic leukodystrophy (MLD) and OTL-103 for Wiskott–Aldrich syndrome (WAS) towards registration and commercialization. The funding will also support the clinical and preclinical development of the company’s rare disease gene therapy pipeline.

“We are thrilled to have such strong support from both new and existing investors in this financing round,” said Mark Rothera, president and CEO of Orchard. “The quality of this investor syndicate is a testament to the confidence we have built among our stakeholders, based on the substantial progress of Orchard’s clinical and preclinical programs since our Series B round last year.”

Frank Thomas, CFO and chief business officer of Orchard, said “This financing provides Orchard with additional capital to rapidly progress our most advanced clinical programs to commercialization. We are advancing our pipeline of potentially transformative gene therapies in primary immune deficiencies and neurometabolic disorders to reach patients as quickly as possible.”

Elise Wang, Principal at Deerfield Management said, “Orchard has made an impressive transition from a start-up company to an emerging leader in gene therapy for rare diseases by building a comprehensive, industry-leading, portfolio of ex vivo gene therapies and assembling a highly experienced team.  We are pleased to have led this round of financing. We believe the company has generated compelling clinical data on products which have the potential to become breakthrough treatments for patients.”

Cowen served as exclusive placement agent for the financing.

 
About Orchard
Orchard Therapeutics is a fully integrated commercial-stage biotechnology company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies.

Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the EMA for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for primary immune deficiencies, neurometabolic disorders and hemoglobinopathies include three advanced registrational studies for ADA-SCID, metachromatic leukodystrophy (MLD) and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.

Orchard currently has offices in the U.K. and the U.S., including London, San Francisco and Boston.

Contacts

Corporate contact
Mary D. Wallace
Orchard Therapeutics
857-291-6266
Mary.Wallace@orchard-tx.com

Media contact
Allison Blum, Ph.D.
LifeSci Public Relations
+1 516 655 0842
Allison@lifescipublicrelations.com

Posted by Sabine Duntze, B3C Group GmbH

San Ramon, CA, USA, August 16, 2018 / B3C newswire / -- rfxcel, the global leader in track and trace solutions, releases enhancements to its compliance solution for Russia and kicks off additional customer implementations in the Russian marketplace.

Russia compliance is now fully embedded in rfxcel’s Compliance Management (rCM) and Serialization Processing (rSP) modules. The extended Russia support builds upon rfxcel’s awarding winning Traceability System (rTS) and continues rfxcel’s long-standing commitment to help customers meet global compliance needs.

rfxcel is actively rolling out its Russia compliance solution for pharmaceutical customers to meet the serialization, aggregation, traceability, and reporting requirements for the Russian market.  As one of the first compliance providers to implement for Russia, rfxcel is strategically positioned to help pharmaceutical companies achieve compliance well in advance of the January 1, 2020 deadline mandated by the Russian government.

Russia’s Federal law 425-FZ requires medicines to be uniquely identified across packing levels with additional Russia-specific cryptography.  Under Russia’s Federal law, participants must track and report products in various stages of the supply chain.  This information is reported to Russia’s centralized Federal State Information System for Monitoring Drug Circulation (FSIS MDC).

“We are extremely proud to work with our customers to meet Russia’s compliance regulations – arguably the most complex in the world.  Delivering a serialization, aggregation and reporting solution for compliance requires not only robust software, but also demands an experienced local and international team with the skills and flexibility to manage an end-to-end project.  rfxcel offers both the solution and service to ensure success,” said Mark Davison, Senior Operations Director, rfxcel Europe.

Many pharmaceutical companies are challenged in providing resources to meet and deliver a fully validated compliance solution.  The rfxcel implementation team consists of both global and local Russian resources who provide a full-service experience.  This approach is extremely well received by our customers and allows them to shift the worry of compliance to rfxcel so they can focus on their core business.

 
About rfxcel
rfxcel is a leading-edge track and trace solution to help companies meet regulatory compliance requirements, protect their products, and brand reputation. rfxcel has been an industry leader since 2003, expanding to locations beyond the US to include the EU, Russia, India, Brazil, and APAC. rfxcel’s unique integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

To learn more about rfxcel or participate in rfxcel’s Russia compliance program please contact us at https://www.rfxcel.com/contact-rfxcel/.

Contact

Herb Wong
Head of Marketing
hwong@rfxcel.com
+1 (925) 824-0300

Posted by Sabine Duntze, B3C Group GmbH

• Product Launch during 2018 BioProcess International in Boston.
• CITSens MeMo is a new, innovative, affordable, and easy to handle single-use wireless bi-parametric metabolic monitoring system that allows the continuous online / real-time measurement of glucose and lactate in cell cultures.

Waedenswil (Zurich), Switzerland, August 20, 2018 / B3C newswire / -- C-CIT Sensors AG, today announced the release of its new sensor product allowing to monitor glucose and lactate in-situ and over weeks using one single-use sensor. The product will be exhibited at booth 1732 during the BioProcess International Conference & Exhibition in the Hynes Convention Center, from 4-7 September 2018 and is available for beta testing as of 4 September 2018.

The measurement of critical process parameters (CPP) such as glucose and lactate is key to the understanding, development and control of bioprocesses of different kinds. Most labs today rely on frequent sampling and off-line analytics in order to follow the dynamics of a cell culture’s growth and metabolic status. These procedures are often manually conducted resulting in error-prone and risky data acquisition and processing. Many of them consume valuable and significant amounts of cell culture volume (and product) over the complete process time and require high upfront investment for instrumentation. 

CITSens MeMo is an electrochemical, enzyme-based sensor with the capacity to be used in defined cell culture media and blood.

The continuous online/in-situ measurement of glucose and lactate as offered by CITSens MeMo adds value to cell line, media and process development projects within the cell bio research and biopharma community. The affordable sensor system is unique and delivers real-time information on a culture’s growth behavior and metabolic state at any given time. Data is being generated at a 20 second frequency and continuously sent to a database via wireless communication out of a closed incubator. Using a smartphone, a round the clock observation of your cell culture is here. Through straightforward OPC server connectivity, process control based on the online measured kinetics of glucose consumption and/or lactate generation has become reality.

The benefits are evident: Easy and fast learning about a cell culture’s metabolic behavior under a given condition and straight forward process development at lowest investment and running cost, no risk of contamination, in-time information and automation, better science and engineering.

The single-use sensor comes as a standard product (a reactor probe containing a PG13.5 thread or as a flow cell sensor) or can be custom-manufactured as a cap sensor fitting any of the widely used brands of different cell culture vessels (T-flask, shake flask, roller bottle).

About C-CIT Sensors
At C-CIT Sensors we continue to develop innovation in this exciting field of easy and affordable metabolic monitoring helping to turn “dumb plastics” into “smart single-use cell culture systems”.

Interested in testing CITSens MeMo in your specific application? Please contact us at Andreas.Koch@c-cit.ch or call +41 79 935 7481

Contact

Andreas Koch
Andreas.Koch@c-cit.ch
+41 79 935 7481

Posted by Sabine Duntze, B3C Group GmbH

Boston, USA and London, UK, August 29, 2018 / B3C newswire / -- Orchard Therapeutics, a leading commercial-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today announced two additions to its ex­­­ecutive leadership team, appointing Kathryn (Katie) Payne as senior vice president, global head of corporate communications and external affairs, and John Cerio as senior vice president, global head of human resources. Ms. Payne and Mr. Cerio will report to Mark Rothera, president and CEO of Orchard.

“I am delighted to welcome Katie and John to Orchard’s executive leadership team, bringing an impressive wealth of experience in their respective fields,” said Mark Rothera. “Katie is a proven communications leader who comes to us with an extensive portfolio of success in global corporate communications, brand building, public affairs and patient advocacy. John has a strong record of executive leadership in the life sciences space and is adept at translating corporate strategy into an effective workforce and organizational plan. We look forward to Katie and John applying their deep expertise as we shape our business for future growth with an unrelenting commitment to enhancing the lives of patients living with rare disease.”

Katie Payne joins Orchard from AMAG Pharmaceuticals, where she served as senior vice president of corporate affairs, directing the company’s communications, government relations and advocacy activities. During her time at AMAG, Ms. Payne led the internal and external communications strategy for six significant corporate and business development transactions and played a key role in the company’s efforts to collaborate with healthcare experts and advocacy groups to advance public health. Her expertise includes stakeholder engagement, issues and crisis management, media relations and corporate identity. Prior to AMAG, Ms. Payne spent a decade at APCO Worldwide where she developed and implemented U.S. and global communications programs for a wide variety of companies and organizations in the healthcare industry. In her role at Orchard, Ms. Payne will be responsible for leading the global corporate communications and external affairs function, spanning internal and external communications, investor relations, patient advocacy and government relations. Ms. Payne graduated Phi Beta Kappa and with high honors from The Johns Hopkins University with a Bachelor of Arts degree in writing and business management and a master’s degree in communications. She currently serves as a member of the MassBio Board of Directors and is also a member of the Board of Directors of the Boston-Manchester March of Dimes chapter.

“I am excited to be joining a team that is so deeply committed to transforming the lives of patients and their families,” said Ms. Payne. “The opportunity to tell Orchard’s story and advance understanding of the company’s innovative approach to gene therapy among a variety of corporate stakeholders compelled me to join Orchard’s dedicated employees and its network of collaborators in this important mission.”

John Cerio brings over 25 years of human resources leadership experience in the pharmaceutical and biotech industry, building high-growth, high-performance, mission-driven and entrepreneurial companies. His expertise includes talent acquisition, leadership and organizational development, human resources planning and mergers and acquisitions. Until recently, Mr. Cerio served as vice president of human resources and administration for Agenus, where he led the human resources and real-estate functions through periods of rapid growth, transformation and global expansion, including the integration of strategic acquisitions in research and technical operations. Prior to Agenus, he was vice president of global human resources for PerkinElmer Life Sciences division, which included their pre-natal and neo-natal genetic screening business. Previously, John spent nearly a decade with Bristol-Myers Squibb Company in roles of increasing responsibility and leadership, including director of organizational development for US Medicines and head of human resources for the oncology and immunology division. Mr. Cerio holds a Bachelor of Science in industrial and labor relations from Cornell University and a Master of Arts in organizational psychology from Columbia University.

“I am thrilled to join the Orchard team at this exciting time in the company’s evolution,” said Mr. Cerio. “I look forward to partnering with Mark and my many talented colleagues across Orchard to facilitate continued organizational growth in support of the company’s mission and values-based culture.”

About Orchard
Orchard Therapeutics is a fully integrated commercial-stage biotechnology company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies.

Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for primary immune deficiencies, neurometabolic disorders and hemoglobinopathies include three advanced registrational studies for ADA-SCID, metachromatic leukodystrophy (MLD) and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.

Orchard currently has offices in the U.K. and the U.S., including London, San Francisco and Boston.

 
Contacts

Corporate contact    
Katie Payne    
Orchard Therapeutics
+1 202 669 6786
Katie.Payne@orchard-tx.com

Media contact
Allison Blum, Ph.D.    
LifeSci Public Relations          
+1 516 655 0842        
Allison@lifescipublicrelations.com

Posted by Sabine Duntze, B3C Group GmbH