First activities resulting from the investment already underway

Ravensburg, Germany, September 30, 2015 / B3C newswire / -- Vetter has announced that in keeping with its commitment to providing customers with the manufacture of high quality drug products, the company will invest approximately 300 million euros to expand and upgrade its manufacturing facilities over an estimated five-year period. As a leading contract development and manufacturing organization, Vetter is continuously developing its manufacturing sites and techniques to prepare them for future needs and requirements. The upgrades are being driven by a changing healthcare market that is affected by issues such as ever-more complex molecules, smaller batch sizes, and increasing regulatory requirements.

The first of the facility expansions are already ongoing at several of the company’s German locations including its ‘Ravensburg Vetter West’ center for visual inspection and logistics. Structural work for the facility enlargement, which will offer more than double of its current capacity, is completed with the site being on schedule to become fully operational in 2017. In addition, the Ravensburg Vetter South production site has also been designated for significant enlargements as is the Ravensburg Schuetzenstrasse facility where initial construction activities began in 2013. All three site expansions will result in additional capacities for drug product manufacturing and logistic services.

A central technology element of the planned upgrades will be the implementation of an in-house made improved restricted access barrier system (RABS) concept which will contribute to increased operational excellence in aseptic manufacturing. For decades, Vetter has relied on RABS as one of the two distinct technologies available today for its aseptic filling processes, the other being isolators. RABS achieves the sterility assurance level (SAL) required by regulatory authorities, and allows for rapid product change-over coupled with high safety. To better meet future industry trends in quality, safety and flexibility, a corporate project team has evolved this ‘Improved RABS concept’ by combining the advantages of isolator and RABS technology. The core of the approach is a uniquely fast, by today’s standards, 3-hour cycle and fully automated decontamination of the cleanroom using hydrogen peroxide (H₂O₂), resulting from an extremely high level of process innovation. Following a successful pilot project in a selected cleanroom the company will now implement this decontamination concept in all of its cleanrooms within the next years.

All of the planned activities are designed to meet future customer expectations and regulatory requirements at an early stage, maintaining a level of manufacturing excellence that customers have come to expect from Vetter. “We are continuously monitoring and reacting to a changing marketplace and are pleased that we are in the position to be able to make these strategic investments to further develop our sites and meet these challenges. Individually and collectively, they will help us keep pace with the market and allow us to continue to build a successful future for Vetter and our customers,” said Vetter Managing Director Peter Soelkner. Managing Director Thomas Otto added “As trusted partners for drug product development and manufacturing, it is our intent to always get each customer’s job done right. In order to reach this level on a continuous basis, these investments are the right step, at the right time.”

Caption: Structural work completed: A portion of the 300 million Euro investment is directed to completion of the Ravensburg Vetter West facility expansion.
For high resolution please click the image.

About Vetter
Vetter is a premier contract development and manufacturing organization (CDMO) and a global leader in the fill and finish of aseptically prefilled syringe systems, cartridges and vials. Headquartered in Ravensburg, Germany, with facilities in Germany and the United States, the company provides state-of-the-art manufacturing, from early clinical development through commercial filling and packaging of parenteral drugs. The CDMO’s extensive experience covers a broad range of complex compounds, including monoclonal antibodies, peptides and interferons. Vetter supports its customers every step of the way, guiding their products through development, regulatory approval, launch and lifecycle management. Known for quality, the company offers a foundation of experience spanning more than 35 years, including dozens of product approvals for novel bio/ pharmaceutical compounds. Since 2014, Vetter operates a representative office in Singapore, increasing the presence of the company and the awareness of its service portfolio in the Asian healthcare market.

Contact

Vetter Pharma International GmbH
Oskar Gold
Senior Vice President Key Account Management,
Marketing / Corporate Communications
Eywiesenstrasse 5
88212 Ravensburg
+49 (0)751-3700-3729
PRnews@vetter-pharma.com

Horsholm, Denmark, October 1, 2015 / B3C newswire / -- ExpreS²ion Biotechnologies, a private Danish company, ("ExpreS2ion") announced today the execution with Boston Children’s Hospital ("Boston Children’s”), located in Boston, Massachusetts, USA, of a non-exclusive research license agreement to use ExpreS²ion’s proprietary recombinant protein expression platform ExpreS² for Boston Children’s academic research. Boston Children’s is the pediatric teaching affiliate of Harvard Medical School.

The ExpreS² platform is being used by top academic and top private industry teams to solve protein expression challenges. The system has proven to be instrumental in advancing research in neglected diseases, including malaria research and vaccine projects, where other expression systems have failed to yield the native properties of the parasite proteins – or even failed to express the proteins. ExpreS² provides high quality, very homogenous expressed proteins, qualities that are needed in structural biology studies.

“ExpreS²ion aims to support the development of novel drugs through solving protein production challenges. Our proprietary technology platform can deliver protein for laboratory use and is also compatible with current Good Manufacturing Practice (cGMP). This interaction with Boston Children’s is part of our strategy to support top academic teams in protein expression. It is our hope that this license will advance the understanding of relevant immunological processes and of malaria vaccine candidates.” said Wian de Jongh, Ph. D., Chief Scientific Officer, ExpreS²ion.

About ExpreS²ion Biotechnologies
ExpreS²ion Biotechnologies is a world leading CRO specializing in developing cell lines and processes based on Drosophila S2 cells. Our company has a proprietary and complete S2 recombinant protein expression platform: ExpreS², which was developed over more than ten years. ExpreS² is a uniquely successful tool for non-viral insect-cell based expression, and we are the only company with in-depth practical experience in how to use it – both in preclinical development and in clinical trials. The ExpreS² platform is excellent in all phases of drug discovery, R&D and manufacturing as it offers fast access to protein and easy establishment of stable polyclonal pools. This results in high protein-expression levels with a regulatory friendly expression system.

Contact

ExpreS²ion Biotechnologies ApS.,
Sancha Salgueiro
+45-41666121
sas@expres2ionbio.com
http://www.expres2ionbio.com
SCION Science Park
Agern Alle 1
2970 Horsholm, Denmark

ADCC-enhancement for innovative cancer therapy, produced via ProBioGen’s accelerated CMC development path.

Berlin, Germany, and South San Francisco, CA, USA, October 1, 2015 / B3C newswire / -- ProBioGen AG and Tizona Therapeutics, Inc. have signed a commercial license and service agreement for cell line and process development. Under the Agreement ProBioGen will develop Tizona’s immuno-oncology antibody up to GMP manufacturing, applying ProBioGen’s proprietary GlymaxX® cell line to boost the antibody’s ADCC anti-tumor activity. The program will follow ProBioGen’s integrated and accelerated development path which allows selecting superior, stable producer clones with robust and excellent process features in a significantly reduced time, facilitating the earlier onset of clinical trials. Manufacturing of clinical study material will be conducted at ProBioGen’s new facility which will house two additional 1,000L single-use bioreactors in its GMP suites.

Volker Sandig, ProBioGen’s CSO commented “We were impressed by the scientific approach and quality of work which Tizona has invested into this product candidate already, and we are looking forward to combining our expertise with that of Tizona for this very promising product candidate.”

René Brecht, VP Process Science and Manufacturing at ProBioGen added “Our accelerated CMC development path allows us to choose clones with optimal product and manufacturing characteristics right from the beginning, resulting in simplified scale-up and reduced time lines.”

Tizona’s COO, Jeremy Bender, commented: We were seeking a high quality service provider with a proven track record and a robust ADCC enhancement technology for our project, and ProBioGen’s package of technical and scientific expertise, timelines, financial terms and, importantly, people behind it, were a compelling combination.”

About ProBioGen AG
ProBioGen is a specialist for developing and manufacturing complex therapeutic glycoproteins.
Combining both state-of-the-art development platforms together with intelligent product-specific technologies yields biologics with optimized properties.
Rapid and integrated cell line and process development, comprehensive analytical development and following 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 1994, is privately owned, and located in Berlin, Germany.

About Tizona Therapeutics
Tizona Therapeutics, Inc., based in South San Francisco, CA, USA, is a preclinical stage biotechnology company that is developing multiple, innovative immuno-oncology and autoimmune therapies. Tizona Therapeutics, Inc. was founded by MPM Capital and leading scientists from Dana Farber Cancer Institute, the University of Pittsburgh, Johns Hopkins, Memorial Sloan Kettering Cancer Center, and Brigham and Women’s Hospital.

About GlymaxX®
The GlymaxX® technology, developed by ProBioGen, prevents the addition of the sugar “fucose” to the N-linked antibody carbohydrate part by antibody producing cells. The absence of fucose enhances ADCC (antibody-dependent cell-mediated cytotoxicity) activity for antibodies directed against cancer and infectious diseases. The GlymaxX® technology is based on the stable introduction of a gene for an enzyme which deflects the cellular pathway of fucose biosynthesis. Moreover, GlymaxX® cell lines can be two cell lines in one: They can either produce afucosylated antibodies, or, by adding fucose to the medium, stably produce fully fucosylated antibodies. The GlymaxX® technology is universally applicable, simple and potent, and can be rapidly applied to any existing antibody producer cell line, any new cell line development or to entire expression platforms. ProBioGen offers this technology royalty-free to third parties.

 
Contacts

ProBioGen AG
Dr. Gabriele Schneider
VP Business Development
Goethestr. 54
13086 Berlin, Germany
+49 (0)30 924 006-0
info@probiogen.de

Tizona Therapeutics
Svetlana Lucas
VP Business Development
San Francisco, CA
601 Gateway Boulevard
Suite 350
South San Francisco, CA 94080
+1 650-553-3300
info@tizonatx.com

Basel, Switzerland, and Konstanz, Germany, October 6, 2015 / B3C newswire / --  Konstanz based contract research organization Trenzyme GmbH and Basel based Celonic AG today announced the closure of a licence agreement on Celonics CHO-K1 based cell line expression platform SEFEX. Under the terms of the deal, Trenzyme acquires the non-exclusive rights and know-how on this technology to establish high performance cell lines for R&D and GMP production purposes for its clients.

The SErum Free EXpression technology, SEFEX, is a royalty-free cell line based on CHO-K1 cells. This powerful platform offered by the Swiss CDMO Celonic can be used throughout the entire development ranging from laboratory cultures to production scale. It is robust, highly performant, easy to implement and guarantees maximum productivity, substantial cost savings and scale-up stability for more project safety. As an experienced R&D cell line developer, Trenzyme is looking forward to enter a new market by the closure of the licence agreement on Celonics SEFEX technology.  

 "We are very happy since the deal enables us to extend our cell line services. From now on, we can additionally offer the generation of a cell line which can not only be used for R&D but also for subsequent GMP manufacturing purposes" said Reinhold Horlacher, founder and CEO of Trenzyme. "With this agreement, we can save our clients time and money on their way from research to pharmaceutical production. There is no further need of two different cell lines as the generated R&D cell line can be directly upgraded to GMP manufacturing. In addition, we can provide maximal comparability of their drug substances from R&D to clinical research. All that at a very competitive price."

"Just last year, we obtained titers beyond 7 g/L of an antibody product, so the technology proved to be extremely efficient. This means less Cost of Goods for the clients." said Karlheinz Landauer, Chief Operating Officer of Celonic. "As Celonics partner, Trenzyme has received a technical service package and was verified by our quality management. Hence, we can guarantee its clients to take over their approved R&D cell lines and upgrade them to a fully GMP compliant Master Cell Bank. In addition, we can transfer the cell lines seamlessly to our process development and GMP manufacturing units."

About Trenyzme
Trenzyme GmbH is a privately owned German contract research organization based in Konstanz, offering a wide range of highly customized services in cell line development and recombinant protein production for its national and international clients, ranging from academia and small biotechs up to big pharmaceutical companies. Since its establishment in 2000, Trenzymes scientific experts have been continuously developing new and comprehensive solutions to provide reliable and highly individualized support for the challenging projects of its clients. Whether their needs are in development of assay cell lines, production cell lines or in recombinant protein production, Trenzyme delivers the perfect solution by always following its clear mission: Accelerating innovation and save valuable research time and budget!

About Celonic
Celonic AG is privately owned CDMO based in Basel, Switzerland providing comprehensive GMP development and manufacturing services for New Biological Entities (NBEs) and Biosimilars worldwide. These services include the development of cell lines, production processes as well as the GMP and non-GMP manufacturing of biopharmaceutical drug substances. In addition, Celonic licenses its proprietary SEFEX cell line technology to clients, drug developer and other service provider. In every aspect Celonic goes one step beyond expectations, to help its partner attain their goals better, more efficiently and reliably.
Empathy, Efficiency and Excellence belong to his business model / philosophy.

About SEFEX
SErum Free EXpression (SEFEX) cell lines developed by Celonic are very powerful and guarantee cost savings. The same cell lines can be used in the early R&D development phase that will later be used for GMP production. This saves time and money as well as considerably improving safety. A license package for SEFEX includes the cell line, a vector set and all relevant information for cultivation, handling, screening and selection.

 
Contacts

Trenzyme GmbH
Yvonne Krumm
Inside Sales & Marketing Manager
Byk-Gulden-Str. 2
78467 Konstanz
Germany
yvonne.krumm@trenzyme.com
Phone: +49 (0) 7531 12290 14

Celonic AG
Dr. Ole Fütterer
Senior Director Sales & Marketing
Eulerstrasse 55
4056 Basel'
Switzerland
ole.fuetterer@celonic.ch
+41 (0) 615649 159

Ajdovscina, Slovenia, October 13, 2015 / B3C newswire / -- BIA Separations is introducing a second generation CIMac™ r-Protein A Analytical Column. This short bed, high performance monolithic column is primarily intended for fast, efficient, and reproducible qualitative and quantitative analyses of immunoglobulin G (IgG). It is suitable for use with HPLC and UPLC systems. Quantification of Immunoglobulin G is possible between 0.20 µg and 20 µg. Its small volume and short column length allow operation at high volumetric flow rates (up to 3 mL/min). The information about product quantity and purity is thus generated in just 1 minute! The column has innovative symmetric design for bi-directional flow, also extending column lifetime.

CIMac™ r-Protein A Analytical Column is therefore the chromatographic tool of choice for in-process (PAT) and final control of IgG purified from cell culture supernatant or human plasma.

To test the column at the special launch price valid only for the next six months, contact your local representative or BIA Separations' sales department (sales@monoliths.com).

 
About BIA Separations Slovenia
BIA Separations Slovenia is the leading developer and manufacturer of CIM Convective Interaction Media® monolithic chromatographic columns optimized for the separation and purification of large bio-molecules and viral particles for analytical, laboratory and industrial scale.

Contact

BIA Separations
Spelca Kompara
spelca.kompara@monoliths.com

Warsaw, Poland, October 13, 2015 / B3C newswire / - On October 13, 2015, OncoArendi Therapeutics Ltd. announced that it selected OATD-01 as its clinical development candidate for the treatment of asthma. Submission of the Company's first Investigational New Drug ("IND") application is expected by mid-2017.

OATD-01 is an orally active, non-steroidal small molecule, which is a potent inhibitor of human and murine acidic mammalian chitinase (AMCase). Based upon available information OATD-01 is thought to be the first chitinase inhibitor to enter development. OATD-01 has excellent oral pharmacokinetic characteristics in three species, with high bioavailability, low clearance and high volume of distribution. In addition, OATD-01 has good metabolic stability, moderate plasma protein binding and does not inhibit or activate human cytochrome P450 isozymes.  The overall DMPK profile of OATD-01 is consistent with the targeted once-a-day oral dosing in humans. OATD-01 is effective in two standard mouse models of asthma (ovalbumin and house dust mite), with anti-inflammatory activity superior to montelukast (Singulair), the only current oral asthma medicine that is used regularly. OATD-01 has low potential for off-target side effects as demonstrated by a clean profile in the Diversity Profile™ (Eurofins, Cerep) consisting of 98 enzymes, ion channels and receptors, and no significant effect against the hERG channel. OATD-01 is also negative in the Ames mutagenicity test.

“We believe that drugs against novel targets from the chitinase protein family have great potential to be transformational medicines in the treatment of several chronic inflammatory diseases.  At OncoArendi, we are dedicated to researching and developing first-in-class small molecule-based therapies that could significantly advance our understanding and treatment of inflammation-based diseases such as asthma, IPF, COPD or IBD," said Marcin Szumowski, PhD, President and CEO of OncoArendi Therapeutics. "We are particularly excited about the potential of our first clinical candidate as an alternative or complementary treatment to the corticosteroid-based asthma therapies such as Advair or Symbiocort. This compound has an excellent safety profile and appears suitable for once-a-day oral dosing, with a completely different molecular target and mechanism of action compared to Singulair.”

Activities in support of IND-enabling pre-clinical testing of OATD-01 are already in progress with initiation of first in human studies expected during the second half of 2017. OncoArendi Therapeutics’ AMCase inhibitors, including OATD-01, are protected by three pending patents covering three structurally different groups of compounds.

About Chitinase Science
Acidic Mammalian Chitinase (AMCase) is one of the enzymes that cleaves chitin - a component of the cell walls of fungi and exoskeletal elements of crustaceans and insects. AMCase has been shown to be induced at sites of Th2-dependent inflammation, including in asthma and represents an attractive, novel target for a small molecule strategy. OncoArendi is working on AMCase inhibitors under a global exclusive license for the initial technology from Yale University. In addition, OncoArendi is conducting research on two other members of the chitinase family, chitotriosidase (Chit1) and chitinase-3-like protein 1 (CHI3L1), also known as YKL-40, which have been shown to play significant roles in numerous diseases.

About OncoArendi Therapeutics
OncoArendi Therapeutics is an innovative biopharmaceutical company dedicated to developing and commercializing novel therapeutics for neoplastic and inflammatory diseases. OAT has broad interest and commitment to chitinase science with three distinct small molecule drug discovery programs directed against different chitinase family targets currently in progress. Potential therapeutic applications for compounds resulting from this R&D Chitinase Platform include treatment of numerous diseases with high unmet medical need, such as idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD), as well as tropical diseases and some types of cancer.

Contacts

Marcin Szumowski
President & CEO
m.szumowski@oncoarendi.com

Stanislaw Pikul
VP Development
s.pikul@oncoarendi.com

OncoArendi Therapeutics Sp. z o.o.
J.J. Rostafinskich 4
02-593 Warsaw
Poland

Cancer Antibody With Enhanced ADCC Potency to be Produced

Berlin, Germany and Vancouver, Canada, October 14, 2015 / B3C newswire / -- ProBioGen AG, a leading specialist for contract development and manufacturing of complex glycoproteins, and Zymeworks Inc., a world-leading antibody therapeutics development company, today jointly announced signing an agreement under which ProBioGen will complete cell line development of a Zymeworks bi-specific antibody product candidate, applying its GlymaxX® Technology to enhance antibody-dependent cell-mediated cytotoxicity (ADCC).

ProBioGen’s CSO, Dr. Volker Sandig, commented: “We have been working productively with Zymeworks for some time already and look forward to contributing to the success of Zymeworks’ Azymetric™ bi-specific antibody platform. Our proprietary CHO expression platform is ideally suited for the expression of bi-specific antibodies with high purities and expression titers. The implementation of our innovative GlymaxX® technology for enhanced cancer cell killing underlines the flexibility of our expression platforms’ tool box approach.”

Dr. Ali Tehrani, Zymeworks’ President and CEO said: “We believe that biotherapeutics developed using the Azymetric™ platform have the potential to create game-changing treatment options for patients with unmet medical needs. Our productive partnership with ProBioGen and their highly skilled team will help advance one of Zymeworks’ therapeutic programs into the clinic. The incorporation of the GlymaxX® technology is one of the key components in enhancing the efficacy of this therapeutic candidate.”

ProBioGen’s CEO, Dr. Wieland Wolf, added: “We are very pleased to work with Zymeworks as a biopharmaceutical company with world-wide recognition for their innovative and potentially life-changing therapeutic candidates. Given our established working relationship, we are confident that together we will help move highly efficacious bi-specific antibody therapeutics towards clinical validation.”

About ProBioGen AG
ProBioGen is a specialist for developing and manufacturing complex therapeutic glycoproteins. Combining both state-of-the-art development platforms together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and following 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 1994, is privately owned, and located in Berlin, Germany.

About Zymeworks
Zymeworks is a privately held biotherapeutics company that is developing best-in-class Azymetric™ bi-specific antibodies and antibody drug conjugates for the treatment of oncology, autoimmunity and inflammatory diseases. The company’s novel Azymetric™ and AlbuCORE™ platforms, and its proprietary ZymeCAD™ structure-guided protein engineering technology, enable the development of highly potent bi-specific antibodies and multivalent protein therapeutics targeted across a range of indications. Zymeworks is focused on accelerating its preclinical biotherapeutics pipeline through in-house research and development programs and strategic collaborations.

About GlymaxX®
The GlymaxX® technology, developed by ProBioGen, prevents the addition of the sugar “fucose” to the N-linked antibody carbohydrate part by antibody producing cells. The absence of fucose enhances ADCC (Antibody-dependent cell-mediated cytotoxicity). The GlymaxX® technology is based on the stable introduction of a gene for an enzyme which deflects the cellular pathway of fucose biosynthesis. Moreover, GlymaxX® cell lines can be two cell lines in one: They can either produce afucosylated antibodies, or, by adding fucose to the medium, stably produce fully fucosylated antibodies. The GlymaxX® technology is universally applicable, simple and potent, and can be rapidly applied to any existing antibody producer cell line, any new cell line development or to entire expression platforms. ProBioGen offers this technology royalty-free to third parties.

Contacts

ProBioGen AG
Dr. Gabriele Schneider
VP Business Development
Goethestr. 54
13086 Berlin, Germany
+49 (0)30 924 006-0
info@probiogen.de

Zymeworks Inc.
Dr. David Poon
Sr. Director, External R&D and Alliances
540-1385 West 8^th Ave
Vancouver BC Canada V6H 3V9
+1 (604) 678-1388
info@zymeworks.com

Munich, Germany and Fountain Valley, CA, United States, October 14, 2015 / B3C newswire / -- Isarna Therapeutics, the leader in transforming growth factor beta (TGF-ß) isoform targeted antisense therapeutics, and Autotelic Inc., a specialist in therapeutic drug monitoring and development, today announced an asset sale and purchase agreement for trabedersen, Isarna’s TGF-ß2 antisense oligonucleotide. Autotelic acquires full and worldwide rights to develop trabedersen, which had previously reached Phase 3 clinical evaluation to treat recurrent high-grade glioma. No financial details of the agreement have been disclosed.

“Autotelic Inc. has a unique expertise and resources that enables them to effectively advance trabedersen. The agreement, made possible by our partners at Egamid Ltd, recognizes our leadership in TGF-ß and our efforts to bring trabedersen to patients while allowing us remain focused on our new generation of antisense oligonucleotides,” said Dr. Philippe Calais, President and Chief Executive Officer of Isarna Therapeutics.

Autotelic utilizes therapeutic drug monitoring to achieve consistent drug levels benefiting both efficacy and toxicity in multiple indications. The company’s leadership has long-standing experience in the development of cancer therapies as part of the team that led the early development of Abraxane®, a protein-bound paclitaxel compound approved by the FDA and EMA for the treatment of solid tumors, which was acquired by Celgene in 2010 when it merged with Abraxis BioScience Inc.
Subsequent to Abraxis, the team formed Igdrasol Inc. to develop next generation Abraxane®. Igdrasol recently was acquired by NantPharma in a deal that could be worth as much as $1.3 billion.

“Trabedersen is an excellent fit for our therapeutic drug monitoring program and provides an exciting opportunity to enhance the development of a truly novel treatment. We are looking forward to advancing this promising antisense oligonucleotide further,” commented Dr. Vuong Trieu, Chief Executive Officer of Autotelic.

About Trabedersen
Trabedersen, developed to target the human TGF-ß2 mRNA, is believed to reverse TGF-ß’s immunosuppressive effects, rendering the tumor visible to a patient’s immune system and resulting in priming and specific activation of the patient’s anti-tumor immune response. Trabedersen was developed by Isarna’s predecessor company at the Biopark in Regensburg. Trabedersen has been granted orphan designation for three tumor indications: high grade glioma (US, EU), pancreatic cancer (US, EU) and malignant melanoma (US).

About Isarna Therapeutics
Isarna Therapeutics has an unmatched commitment to developing selective TGF-ß inhibitors to effectively treat ophthalmic and fibrotic diseases and fight cancer. We are advancing a unique pipeline of novel oligonucleotides and combination modalities to transcend clinical response and improve patient outcomes. Isarna is established in the Netherlands, Germany, and the United States. 

About Autotelic Inc.
Autotelic Inc. develops novel treatments using therapeutic drug monitoring. The company was incorporated in 2011 and is headquartered in Fountain Valley, California, United States.

Contacts

Isarna Therapeutics
Dr. Andrea Kottke
Head Medical Affairs and Communication
media@isarna-therapeutics.com
+49 151 11 354 175
or
Gretchen Schweitzer
MacDougall Biomedical Communications
gschweitzer@macbiocom.com
+49 89 2424 3494 or +49 172 862 8540

Autotelic Inc.
Vuong Trieu, PhD
CEO
info@autotelicinc.com
+1-714-445-0127

Company’s second office in the region will strengthen customer relations and help develop new business among emerging and established Japanese companies

Tokyo, Japan, and Ravensburg, Germany, October 14, 2015 / B3C newswire / -- Vetter, one of the global leaders in the aseptic manufacturing of drug-delivery systems, servicing the top-ten pharma/biotech companies worldwide along with mid-size firms and emerging startups, today announced the opening of a new business entity in Tokyo, Japan. The announcement was made at a ceremony attended by executives of customer and partner companies with a presence in the Asian region, as well as Vetter and industry executives. Mr. Hiroaki Suzuki in his role as Business Development Manager for Vetter Pharma International Japan K.K., will lead Vetter’s business activities in Japan, reporting to Ms. Chervee Ho based in Singapore in her role as Director Key Account Management Asia Pacific.

The new office underlines the importance of Japan for Vetter’s business activities. As the second largest pharmaceutical single market, Japan is home to a number of leading global companies which offer a promising injectable pipeline. It is also a point of departure for several established Japanese companies for increasing their global reach. As such, the new office will support customer relations and aid in the development of new business within Japan, while strengthening the global position of Vetter, particularly in selected Asia Pacific markets. As a strategic partner, Vetter supports its worldwide clients through every phase of their drug product’s lifecycle, from early product development to launch to commercial supply.

“For more than 35 years, the name Vetter has been synonymous with high-quality aseptically prefilled drug-delivery systems. With our office opening in Japan, we continue to build upon that history with a further demonstration of our strategy to better service the needs of our growing customer base worldwide, including Asia,” said Udo J. Vetter, Chairman of the Advisory Board and member of the owner family.

“Our presence in Japan will help to increase awareness of Vetter’s services in this growing healthcare market by presenting our expertise and market position onsite,” added Managing Director Peter Soelkner. “Following the creation of our Asia Pacific hub in Singapore last year, the new office is a further development, establishing a dedicated presence in the most important single market of the region. This activity affords us the opportunity to strengthen personal contacts with national audiences.” 

“Vetter’s decision to expand their presence in the Asia Pacific region and to open their first office in Japan is a strong message of their commitment to service the needs of this important market,” said Dr. Hitoshi Kuboniwa, Senior Vice President and General Manager of Pharmaceutical Technology Division at Chugai Pharmaceutical Co., Ltd. “As a trusted partner, we appreciate that step, wishing Vetter as a company in general, and Ms. Ho and Mr. Suzuki in particular, a promising start for their onsite activities in Japan.”

The new office is located in district Shinagawa, which is one of the 23 wards of Tokyo, and a rapidly developing area. Situated on the 28^th floor of a business tower directly across from Shinagawa station, being one of the transportation hubs in Tokyo, the office offers ease of accessibility for many JR Rail lines with proximity to international Haneda and Narita airport through direct train connections.

Caption: Left to right: Dr. Hitoshi Kuboniwa (Senior Vice President and General Manager of Pharmaceutical Technology Division at Chugai Pharmaceutical Co., Ltd.) and Peter Soelkner (Managing Director Vetter) share in the cutting of the ribbon signaling the opening of the Vetter Pharma International Japan K.K. office, its second in the Asia Pacific region.
For high resolution please click the image.

About Vetter
Vetter is a premier contract development and manufacturing organization (CDMO) and a global leader in the fill and finish of aseptically prefilled syringe systems, cartridges and vials. Headquartered in Ravensburg, Germany, with facilities in Germany and the United States, the company provides state-of-the-art manufacturing, from early clinical development through commercial filling and packaging of parenteral drugs. The CDMO’s extensive experience covers a broad range of complex compounds, including monoclonal antibodies, peptides and interferons. Vetter supports its customers every step of the way, guiding their products through development, regulatory approval, launch and lifecycle management. Known for quality, the company offers a foundation of experience spanning more than 35 years, including dozens of product approvals for novel bio/ pharmaceutical compounds. Since 2014, Vetter operates a representative office in Singapore, increasing the presence of the company and the awareness of its service portfolio in the Asian healthcare market.

Contact

Vetter Pharma International GmbH
Oskar Gold
Senior Vice President Key Account Management,
Marketing / Corporate Communications
Eywiesenstrasse 5
88212 Ravensburg
+49 (0)751-3700-3729
PRnews@vetter-pharma.com

Cancer Vaccine OQR200 Elicits Broad and Strong Immune Response to Her2/neu

Vienna, Austria, October 15, 2015 / B3C newswire / -- OncoQR ML, a company developing Adjustable Cancer Immunotherapies, today announced that its breast cancer vaccine candidate OQR200 has successfully completed a proof-of-concept study in non-human primates (NHPs). In the study, the vaccine elicited the expression of very high levels of polyclonal antibodies targeting multiple epitopes on Her2/neu. These epitopes include those two which are recognized by current blockbuster monoclonal antibodies Herceptin and Perjeta and which lead to ADCC (antibody dependent cytotoxicity). In addition, antibodies against Her2/neu epitopes so far not targeted by any licensed therapy were induced. These new epitopes allow tumor cell killing through complement activation (CDC), confirming the superior mode of action of polyclonal responses over current monoclonal treatments. Importantly, on top of the antibody response, OQR200 simultaneously induced polyclonal cellular immune responses to the breast cancer antigen, activating both helper T-cells and cytotoxic T-cells. Thus, OQR200 mobilizes and boosts the patient’s complete immunological repertoire to combat the cancer cells. No adverse reactions were observed.

“We are very pleased that this study has proven that OQR200 induces both high levels of antibodies and T-cell responses to Her2/neu-cancer cells”, commented Dr. Geert C. Mudde, CSO of OncoQR. “The results of this study show that compared to other drugs OQR200 is capable of mobilizing and boosting both arms of the immune system against cancer cells: cellular and humoral immunity. Such a two-pronged approach is considered critical to prevent ‘tumor escape’, a major limitation of current antibody treatments.”

Dr. Mudde continued: “As an immunologist I am extremely excited that we could show that with our S-TIR™ technology underlying OQR200, an autologous antigen can overcome immune tolerance. This has been a longstanding challenge for active cancer immunotherapy. Equally important for the clinical potential of our technology is the fact that the strong and broad immune reaction OQR200 induces is reversible, as the body will return to its natural state of tolerance for the auto-antigen after the end of the vaccination schedule, when immunization pressure is released. In addition, this also means that the immune response can be fined-tuned on a patient-by-patient basis to reach the individually desired optimal levels by shortening or increasing the time period between immunizations of the patient.”

“This study with OQR200 is the third indication in which our proprietary and highly versatile S-TIR™ technology has shown proof of concept again in the absence of side effects”, commented Christof Langer, MBA, CEO of OncoQR. “We are delighted that we could move OQR200 from drawing-board to pre-clinical proof of concept in just eight months. Our next goal is to find adequate partners that will help bring this promising breast cancer vaccine to the clinic as fast as possible.” Discussions with potential partners have already started, Langer added.

Over the next months, OncoQR plans to use the versatile S-TIR ™ technology underlying OQR200 to initiate the development of further Adjustable Cancer Immunotherapies against undisclosed clinically validated targets. 

About OncoQR’s Technology
OQR200, an anti-cancer immunotherapy vaccine, is based on a highly versatile, modular technology platform: S-TIR™ (specific T-cell immune remodeling). The vaccines based on this platform are comprised of two modules, a generic module (the “warhead”) and a disease-specific module (the antigen, or “immunogen”).

Module 1, the warhead, ensures that the immunogen is directed to the cells that initiate and execute the immune response to the immunogen (plasmacytoid dendritic cells (pDCs), and other antigen presenting cells as well as Module 2-specific B-cells). Module 1 primes pDCs to specifically break the tolerance against the tumor-associated antigen in Module 2, leading to activation of helper T-cells and cytotoxic T-cells which are specific for the immunogen in Module 2 and at the same time Module 1 breaks tolerances in Module 2 specific B-cells. This tolerance generally keeps the immune system of an individual from turning against itself, including tumor cells. After end of treatment with S-TIR™ vaccines, the “natural” tolerant status of B- and T-cells in the body returns.

In addition, Module 1 strongly boosts the response of the immune system and acts as an intrinsic “adjuvant” for both pDCs and immunogen-specific B-cells.

Module 2, the immunogen, represents the disease- or cancer-specific antigen. In the case of OQR200, the immunogen is Her2/neu, a protein overexpressed on the surface of breast cancer cells.

Both modules are linked by high-affinity connectors.

OncoQR’s modular technology is derived from the S-TIR™ technology platform, which was originally developed by S-TARget therapeutics for the treatment of severe allergic diseases. S-TARget’s founders recognized the potential for its S-TIR™ technology in cancer immunotherapy and subsequently founded OncoQR ML GmbH.

Before showing proof of concept in triggering a reversible immune response against the breast cancer target Her2/neu in a in a pre-clinical trial, the technology has shown in vivo proof of concept in a severe form of house dust mite-induced allergic asthma as well as in pancreatic cancer. No side effects were observed in either study.

About OncoQR ML
OncoQR ML (OQR) is a biotech start-up that develops novel, adjustable cancer immunotherapies (ACIs) to treat oncologic diseases.

OncoQR’s ACIs are based on the unique, proprietary human-specific S-TIR™ technology platform, which enables the patient’s immune system to generate a powerful immune response against tumor-associated antigens.

OncoQR’s lead candidate, OQR100, targets neutralization of G17 (“little gastrin”, a peptide growth factor/hormone produced by gastro-intestinal cancer cells) for treatment of pancreatic and gastric cancers and is in co-development with TYG Oncology Ltd. under the name TYG100.

The Company’s second most advanced program, OQR200, is a new candidate against Her2/neu to treat e.g. breast cancer.

In the next two years, several undisclosed new ACIs against clinically validated targets will be developed until at least in vivo proof of concept in Cynomolgus monkeys, after which the company will either seek for partners to bring these new ACIs into the clinic or to out-license the products.

OncoQR was founded by two experienced senior pharma professionals with top-level research & development as well as life-science management backgrounds: Christof Langer, MSc, MBA and Geert C. Mudde, PhD. The privately held company is based in Vienna, Austria.

 
Contact

OncoQR ML GmbH
Christof Langer, CEO
Mooslackengasse 17
1190 Vienna
Austria
www.oncoqr.com
c.langer@oncoqr.com
+43 664 5160032

• New S80 film features consistent cell growth, robustness and high quality
• Flexsafe® 3D shipping solutions meet stringent ASTM D4169 Standard Practice
• Pre-designed Solutions (PDS) proven for every process step in biomanufacturing

Goettingen, Germany and  Aubagne, France, October 15, 2015 / B3C newswire / -- Today, single-use bags are increasingly used in all process steps of biopharmaceutical manufacturing. Their robustness, performance and quality consistency are crucial for ensuring the safety and economy of bioprocesses. This is why Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, developed a new polyethylene film and the Flexsafe® family of bags that provide outstanding quality and significantly facilitate implementation of next-generation single-use factories. The complete control of the resins, film, bags and their final assembly, as well as dedicated supply chain and quality management for critical fluid-contact components, provides assurance of supply, reliable performance and a consistent extractable/leachable profile of Flexsafe® across all process steps.

Designed for storage and shipping of biopharmaceutical fluids, SSB’s new Flexsafe® 3D Pre-designed Solutions (PDS) meet all the functional and validation requirements of the biopharmaceutical industry. These solutions feature the appropriate components, functionalities and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling. Fluid-contact components are available off the shelf and their availability is backed by at least 24-month change notification to provide the best delivery reliability and business continuity.

The three-dimensional single-use bags are available in a range of sizes from 50L to 1,000L and are made of exceptionally robust, yet highly flexible, 400 µm thick co-extruded film structure. The strength of this film reduces the risk of damage to the bag, and its flexibility ensures easy installation and self-deployment of bags in containers, such as SSB’s stainless steel or plastic Palletanks®. The outstanding robustness of Flexsafe® bags has been demonstrated by shipping tests conducted in both airplanes and trucks and by applying the most stringent ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. This standard is designed to reflect worst-case conditions at several temperatures.

“With our Flexsafe® PDS, customers can easily select and safely implement single-use solutions proven for each process step. They will fully benefit from excellent cell growth in upstream, robustness in downstream and a consistent extractable profile in final drug products,” stated Jean-Marc Cappia, Vice President of Marketing for Fluid Management Technologies at SSB.

For further information, please visit www.sartorius-stedim.com.

 For high resolution please click the image.

Image Files (links for downloading):

www.sartorius.com/fileadmin/media/global/company/flexsafe_3d_bag-1.jpg
www.sartorius.com/fileadmin/media/global/company/flexsafe_3d_bag-2.jpg
www.sartorius.com/fileadmin/media/global/company/flexsafe_pe_film.jpg

A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.”

Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech has a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,700 people, and in 2014 earned sales revenue of 683.5 million euros.

Contact

Dominic Grone
Group Corporate Communications
Sartorius AG
Goettingen
Germany
+49.(0)551.308.3324
dominic.grone@sartorius.com
www.sartorius.com

Berlin, Germany, and Uppsala, Sweden, October 15, 2015 / B3C newswire / - BioGenes GmbH, a global leader in host cell protein (HCP) assay development, and Gyros AB, a pioneer in miniaturizing and automating immunoassays at nanoliter-scale, announce a cooperation for use of BioGenes’ 360-HCP antibodies in Gyrolab™ CHO-HCP Kits 2-5. The four Gyrolab™ CHO-HCP Kits, which have been introduced recently, quantify host cell proteins from Chinese hamster ovary (CHO) cells and are used in biomanufacturing processes.

360-HCP antibodies from BioGenes have been developed according to a novel approach and stand out by their ability to cover the broadest possible spectrum of antigens. 360-HCP antibodies have been generated by immunizing different species combined with an optimized antigen and antibody preparation as well as purification strategy resulting in several antibody preparations. Thus each Gyrolab™ CHO-HCP Kit contains antibody preparations that have been generated in different species using slightly different antigens.

Gyros’ kits are validated for use on the nanoliter-scale microfluidic systems Gyrolab xP workstation and Gyrolab xPlore which are in use in GLP and GMP environments in most of the top biopharma and CROs across the world. Primarily, BioGenes has developed the 360-HCP antibodies for its enhanced generic CHO|360-HCP ELISA. Through the collaboration with Gyros the 360-HCP antibodies can now also be used in in high-throughput analyses.

The new Gyrolab™ CHO-HCP Kits will be showcased at BPI 2015 on 26-29 October in Boston, MA.

About BioGenes
BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.

About Gyros
Gyros manufactures laboratory instruments, consumables, kits and software to maximize laboratory productivity by miniaturizing and automating immunoassays at nanoliter-scale. Gyrolab™ systems use proven microfluidic CD technology to analyze large numbers of samples in parallel, ensuring uniform processing and yielding up to 112 data points in less than one hour. Gyros will put a new spin on what’s possible in your laboratory.

Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

Copenhagen, Denmark, October 19, 2015 / B3C newswire / -- Nuevolution A/S today announced that it has entered into collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, using Nuevolution’s proprietary Chemetics® drug discovery platform. The collaboration was facilitated by Johnson & Johnson Innovation, in partnership with Janssen Discovery Sciences.

Nuevolution, a privately held Copenhagen-based biotechnology company is applying its propriety drug discovery platform to the generation of novel small molecule therapeutics. Today they announced a multi-target collaboration with Janssen. The collaboration will focus on the discovery and development of new medical entities for the treatment of oncological, infectious and inflammatory diseases.

Within the framework of the collaboration, Nuevolution will apply its drug discovery platform Chemetics® to discover and advance drug candidates against drug targets of interest to Janssen. Under the terms of the agreement, Nuevolution will receive an upfront payment, research funding and would be eligible to milestone payments upon achievement of specified research, development and commercial milestones. In addition, Nuevolution would be entitled to receive certain royalty payments on net-sale of products that may be commercialized as a result of the collaboration.

“We are excited about entering into the extensive collaboration with Janssen,” said Alex Gouliaev, CEO of Nuevolution A/S and continued, “We are looking forward to an excellent working relationship with their dedicated research and development teams.”

About Nuevolution
Nuevolution is a leading small molecule drug discovery biotech company founded in 2001, and based in Copenhagen, Denmark. Nuevolution partners its discovery platform and programs with pharmaceutical and biotechnology companies to seek future benefit of patients in need of novel medical treatment option. Nuevolution’s internal programs are focused on therapeutically important targets within inflammation, oncology and immuno-oncology.

The company has developed its proprietary drug discovery platform Chemetics®, a unique, patent protected hybrid of proven wet chemistry and molecular biology which represents the ultimate fragment based drug discovery platform for both identification and optimization of hit to candidate compounds. Chemetics® enables rapid oligonucleotide e.g. DNA encoded synthesis of up to billions of chemically diverse drug-like small molecule compounds, and the efficient screening and optimization of these, facilitating the identification of potent drug leads at unprecedented speed and scale.

Nuevolution has also entered into agreements with Merck & Co. (MSD), Lexicon Pharmaceuticals, GlaxoSmithKline, Novartis, Boehringer Ingelheim and Cancer Research Technology, where Lexicon Pharmaceuticals, GlaxoSmithKline and Novartis have entered into technology licensing agreements with Nuevolution. Nuevolution has also entered a scientific collaboration by and between Duke University, Howard Hughes Medical Institute, Lexicon Pharmaceuticals and Nuevolution.

Nuevolution is a privately owned company by key Scandinavian investors, including SEB Venture Capital, Sunstone Capital and Industrifonden.

Contact

Alex Haahr Gouliaev
Chief Executive Officer
Nuevolution A/S
+45 7020 0987
ahg@nuevolution.com

Chemetics® is a registered trademark of Nuevolution.

Chemetics® is a patented technology of Nuevolution: EP1402024, EP19005829, EP2305808, US7727713, US8932992, EP1487978, EP2186897, US7413854, US8808984, EP1539980, EP1756277, US13/179283, EP1608748, EP2236606, US 7915201, EP1558744, EP2348124, AU2003273792, AU2011226815, CNZL200380104764.5, HK1082742, HK1149947, IN213390, IL167531, JP4895608, JP5643398, ZA2005/02624, NZ538993, SG111515, US8206901, US8722583, US13/455223, US14/099106, US7704925, EP1957644, US14/571941, US14/340123, US10/539288, US13/179283, CA2544153, CN201210222023.8, EP10184069.2, HK11107866.3, IL207672, IN178/MUMNP/2007, JP2010-226107, US13/455,223, US14/099106, US10/572,644, EP10192716.8, EP10192717.6, US12/095778, CA2832672, EP11720372.9, IN9924/DELNP/2012, US13/641,588.

LUNARIS™ multiplexing platform is applied in epidemiological studies for AMD

Cologne, Germany, October 22, 2015 / B3C newswire / -- AYOXXA Biosystems GmbH, an international biotechnology company, is one of two industrial partners of EYE-RISK, a large biomedical consortium bringing together the expertise of ten renown scientific and clinical institutions and a patient organization from six European countries. It is led by Prof. Dr. Marius Ueffing of the University Medical Center of Tübingen, Germany and Prof. Dr. Caroline Klaver of the Erasmus University Medical Center Rotterdam, Netherlands. AYOXXA contributes the LUNARIS™ technology platform to develop biomarker footprints to stratify patient subgroups.

The program is funded by the Horizon 2020 Research and Innovation Program of the European Union, aiming to study the combined role of genetic and non-genetic factors for developing Age-Related Macular Degeneration (AMD), an incurable disease and leading cause of blindness in Western countries. The consortium had its kick-off meeting in June this year. The program is funded with 6 Mio. EUR until 2019.                    
EYE-RISK follows a multi-disciplinary approach exploiting epidemiological data and biosamples from large European eye cohorts and biobanks. Various risk factors including genes, environment, life style and age will be correlated with molecular data about pathways and drivers of AMD with the goal to improve diagnostics, to develop better therapies and to ultimately prevent blindness.          

“We are pleased to join this very prestigious expert network in EYE-RISK and are looking forward to developing assays to footprint specific biomarkers within large patient groups on our powerful LUNARIS™ protein multiplexing platform,” comments Dr. Markus Zumbansen, VP Research and Development at AYOXXA Biosystems GmbH. “With EYE-RISK, we follow our strategy to develop advanced ophthalmic diagnostic tools.”

Prof. Dr. Marius Ueffing adds: “We welcome AYOXXA as the expert in multiplex analysis in our consortium. We need faster protein testing solutions that generate more information out of precious samples without compromising data quality. EYE-RISK will bring a significant shift in our approach to the treatment of individuals suffering from AMD”.         

About AYOXXA
AYOXXA Biosystems GmbH, an international biotech company based in Cologne (Germany), Boston (USA) and Singapore, has developed LUNARIS™ the proprietary technology platform for multiplex protein analysis. LUNARIS™ BioChips enable researchers to perform simultaneous detection of multiple biomarkers in very small sample volume. Founded in 2010, AYOXXA is a biotech spin-off company of the National University of Singapore (NUS). Core to the cutting-edge technology is a bead-based method that yields 10,000-fold more data points than a standard immunoassay.
LUNARIS™ was developed at Associate Professor Dieter Trau’s laboratory at the Department of Biomedical Engineering at NUS.
In September 2015, AYOXXA launched LUNARIS™ 6-Plex Cytokine Kits to analyze prominent biomarkers that are important in inflammation and in immune regulation in human and mouse. Together with a sample volume down to 3 µL, an increased assay robustness, and using fluorescence readout, AYOXXA will innovate biomedical research, pharmacological screening and preclinical diagnostics development.

Contact

AYOXXA Biosystems GmbH
Dr. Marion Lammertz
Marketing Manager Communications
Nattermannallee 1
50829 Köln
+49 (0) 221 222529 41
marion.lammertz@ayoxxa.com
www.ayoxxa.com

Uppsala, Sweden, October 26, 2015 / B3C newswire / -- Biotage (STO: BIOT), a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, is pleased to announce the introduction of Isolera™ Assist, a new intelligent user experience for their flash purification systems.

Isolera™ Assist provides a structured guide for users resulting in consistent purification conditions and an intelligent way to select optimal cartridges based on crude sample mass and TLC data.  Isolera™ Assist is available to all Isolera instruments, making each system a simple to use purification instrument. Isolera™ Assist simplifies the setup procedure of a purification run, incorporating intelligence that guides the user to utilize the system in the most economical way to quickly and reliably isolate pure compounds. The patented gradient prediction and gradient optimization tools predict gradient shape and sample loading as well or better than an experienced chemist.

“Using Isolera Assist is like having a senior chemist/mentor with 30 years of experience watching over your shoulder. Helping you produce successful purifications with a minimum of risk, time spent and cost.  With Isolera™ Assist, we bring the benefits of our Accelerated Chromatographic Isolation (ACI™) system to the next level, integrating both in a simple to use setup procedure for every chemist, regardless of their experience level” says Biotage Flash Purification Product Manager, Tobias Nordin.

For further information visit www.biotage.com or call: in Europe +46 18 56 57 10, in North America toll free 1 800 446 4752, in Japan +81 3 5627 3123, other areas please call +46 18 56 57 10.

About Biotage
Biotage offers solutions, knowledge and experience in the areas of analytical and medicinal chemistry. Customers include the world’s top pharmaceutical and biotechnology companies, as well as leading academic institutes. The company is headquartered in Uppsala, Sweden, with offices in China, Japan, the United Kingdom, the United States and a worldwide network of distributors. Biotage has 293 employees with sales of 490 MSEK in 2014. Biotage is listed on the NASDAQ OMX Nordic Stock Exchange. 

Contact

James Churchill
Marketing Communications
Biotage GB Ltd.
Distribution Way
Dyffryn Business Park
Ystrad Mynach
Hengoed, Wales  CF82 7TS
United Kingdom
Tel: +44 (0)1443 811 849
Mobile: +44(0)7875484778
Email: james.churchill@biotage.com

Berlin, Germany, October 27, 2015 / B3C newswire / -- BioGenes GmbH, a global leader in host cell protein (HCP) assay development, today announced that it has launched a generic HCP assay with improved HCP recovery properties for E.coli cells. The E.coli|360-HCP ELISA allows sponsors and biotech companies to postpone the development of a cost-intensive specific HCP assay until a more informed decision on the success of a biologic in development can be made.

The E.coli|360-HCP ELISA has been developed using the 360-HCP ELISA approach. While traditional generic HCP assays provide just one single antibody that must work for all processes the generic 360-HCP ELISA provides several kits, each using a different anti-HCP antibody so sponsors can try multiple antibodies to find the one that works best for their samples. An upfront performance test identifies the most suitable ELISA kit thus allowing to greatly increasing HCP recovery.

Dagmar Schwertner-Knoll, Marketing Director of BioGenes GmbH said: “We have evaluated the new generic HCP ELISA for E.coli extensively. For all samples tested we found that at least one of the four kit types was superior to the competitor kit.”

E.coli|360-HCP assay is based on W3110 and BL21 (DE3) cell lines which were fermented in different culture media and temperatures resulting in four antigen preparations with distinct HCP patterns. By immunizing goats with these antigens, BioGenes has developed a panel of four different HCP ELISAs that together build up the enhanced generic E.coli|360-HCP assay.

For all four assay types the lower limit of detection (LOD) is between 0.2–0.5 ng/ml and the lower limit of quantification (LOQ) is 0.6–1.6 ng/ml with a working range between 2–100 ng/ml. A high specificity for the antigen in all four assays was determined by 2D western blotting with the respective antibodies.

The E.coli|360-HCP ELISA will be presented at booth 422 at the BioProcess conference held on Oct 26-29, 2015 in Boston, MA, USA.

About BioGenes
BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.

Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

Trastuzumab Development and Transfer for First Indonesian On-Site Production

Berlin, Germany, and Bandung, West Java, Indonesia, October 28, 2015 / B3C newswire / -- ProBioGen AG and Bio Farma signed an agreement for the development of a biosimilar Trastuzumab for cancer treatment. The goal of the co-operation is the supply of the Indonesian patients with cost-effective high quality biopharmaceuticals. Under the terms of the agreement ProBioGen will develop a highly efficient manufacturing process based on a specifically designed recombinant CHO-cell line, conduct engineering runs and the industrial scale-up.

The turn-key process, including state-of-the-art analytics, will then be transferred to Indonesia to enable local market production. The agreement is fee-for-service based, license and royalty-free.

Dr. Wieland Wolf, ProBioGen’s CEO commented: “This is the 1st Trastuzumab molecule which will be produced locally for the Indonesian market to provide effective modern medicines for a country of 250 million people. We are proud to be a partner of the well-established and experienced Bio Farma, a government company with a successful history of more than 120 years.”

Dr. Gabriele Schneider, Vice President Business Development of ProBioGen added: “The task to develop high-quality therapeutic proteins with high productivity but low commercial-scale production costs fits very well to our passion for developing intelligent biopharmaceutical solutions, based on our in-house CHO manufacturing platform of adapted cells, robust and economical process development know-how and chemically defined media platform.”

Dr. Iskandar, President Director of Bio Farma stated “Bio Farma is proud to be collaborating with ProBioGen. This collaboration will undoubtedly enhance our vision to enter lifescience industry, where in future it will contribute to producing high-quality biopharmaceuticals particulary for the Indonesian people and others in the world.”

Caption: Dr. Iskandar, President Director of Bio Farma (right) and Dr. Wieland Wolf, CEO of ProBioGen (left)
For high resolution please click the image.

About ProBioGen AG
ProBioGen is a specialist for developing and manufacturing complex therapeutic glycoproteins.
Combining both state-of-the-art development platforms together with intelligent product-specific technologies yields biologics with optimized properties.
Rapid and integrated cell line and process development, comprehensive analytical development and following 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 1994, is privately owned, and located in Berlin, Germany.

About PT Bio Farma
Bio Farma is a state-owned vaccine and immunosera manufacturer in Indonesia and plays a vital role in supporting the National Immunization Program. All vaccines needed by the Government are supplied by Bio Farma. The company has an extensive and strong major goal to responsibly endure its high quality vaccine production whilst holding the awareness to persistently develop a green industry by covering all the aspects of the green industry’s activities. Bio Farma was established in 1890 and throughout its long history, the company has gone a long way since its existence to become one of the renowned WHO Prequalified vaccine manufacturers in the world. Bio Farma’s products are exported to numerous countries both bilaterally as well as to UN Agencies. Bio Farma plays an active role in various international organizations such as WHO, International Vaccine Institute, DCVMN, GAVI and Self Reliance in Vaccine Production- in OIC. In order to achieve more breakthroughs ahead, the company  commits to be actively engaged in research and product development activities, both independently or collaborating with prominant  partners. This activity will ultimately give rise to new innovative products based on new technology platform.

Contacts

ProBioGen
Dr. Gabriele Schneider
VP Business Development
ProBioGen AG
Goethestr. 54
13086 Berlin, Germany
+49 (0)30 924 006-0
info@probiogen.de

PT Bio Farma
M. Rahman Rustan
Corporate Secretary
Bio Farma
Jl. Pasteur No. 28 Bandung
40161 Indonesia
+62 22 2033755
mail@biofarma.co.id

Nijmegen/Utrecht, the Netherlands, October 29, 2015 / B3C newswire / -- InteRNA Technologies B.V., a biopharma company engaged in the development of microRNA (miRNA)-based therapeutics for oncology, announces today the closing of an equity financing round. This final extension of its Series A was co-led by new investors INKEF Capital and Aglaia Oncology Fund II. Existing shareholders also participated in this round, bringing the total Series A funding to US$ 10.5 million.

The proceeds of this financing will be used to progress several lead product candidates, through preclinical studies towards clinical development and for further expansion of the management team.

InteRNA has miRNA compounds under development with proven pleiotropic effects across multiple oncogenic signaling pathways and cellular processes. Therefore, these compounds have the potential to become the next generation of drugs for the treatment of a broad spectrum of different human cancers.

In parallel to this funding, InteRNA is pleased to announce that Hans Schikan, former CEO of Prosensa, has become the new chairman of its Supervisory Board. Further joining him and current member Mark Vaeck (CEO of Complix) on the Supervisory Board are Lucas de Breed and Karl Rothweiler for the new investors. The Board is further completed by Samuel Gerssen (for Waterman 40 Holding) and new independent member Brian Bronk (Sanofi Sunrise, part of the Sanofi Global R&D organization).

 “We are very pleased to have these new experienced Board members and professional investors on board. We are now fully geared up to progress development of our lead compounds and further validate the power of our platform. The strong Board and investor base provides us a great outlook on further funding for clinical trials”, said Roel Schaapveld, CEO of InteRNA Technologies.

Hans Schikan commented: “I am excited to chair the Supervisory Board of InteRNA. RNA therapeutics are coming of age and have the potential to form a novel class of drugs next to small molecules and antibodies. InteRNA takes a unique position in the miRNA field through its agnostic functional screening approach delivering miRNA drug candidates which regulate multiple genes across cancer pathways.’’

“With the maturation of miRNA as a novel therapeutic modality, we believe that InteRNA has a strong foundation to translate their proprietary collection of functionally-validated leads into a clinical pipeline of compelling drug candidates, with the aim to substantially impact care for cancer patients”, commented Lucas de Breed, PhD, of INKEF Capital.  

About INKEF Capital
INKEF is an Amsterdam, the Netherlands, based venture capital firm that is focused on the long-term collaboration and active support of innovative technology companies. INKEF was founded in 2010 by Dutch pension fund ABP and with € 200 million under management, it is one of the largest venture capital funds in the Netherlands. INKEF focuses on investment opportunities in Healthcare, Technology and IT/NewMedia and prefers to participate from series A round financing onwards.

About Aglaia Oncology Fund II
Aglaia is a venture capital firm based in Bilthoven, the Netherlands. Aglaia invests in companies with technologies for the prevention and treatment of cancer. With three funds under management, Aglaia focuses exclusively on oncology, and distinguishes from other funds through its early-stage commitment and hands-on involvement. Aglaia aims to translate groundbreaking research into commercially and clinically successful products. The clear combination of financial and social return gives form to impact investing.

About InteRNA Technologies B.V.
InteRNA Technologies develops cancer therapeutics based on a broadly applicable proprietary technology platform for the rapid identification and validation of therapeutic miRNAs. At present, InteRNA has established in vivo proof of concept for multiple pipeline candidates. The Company is pursuing a proactive partnership strategy to acquire appropriate delivery technologies for its products and expects to engage in corporate partnerships to progress several of its products into clinical development.

InteRNA Technologies was incorporated by Aglaia Oncology Fund I as a spin-off from the Hubrecht Institute, Utrecht, the Netherlands.

Contact

Roel Schaapveld, PhD, MBA
CEO
InteRNA Technologies B.V.
+31 (0)24 352 96 33 / +31 (0)30 2532386
schaapveld@interna-technologies.com

Corporate office
Nijmegen City Centre
Jonkerbosplein 52
6534 AB Nijmegen
The Netherlands

Focus is to discover small molecule lead candidates for multiple oncology indications

Darmstadt, Germany, Krakow, Poland, November 2, 2015 / B3C newswire / -- Merck, a leading science and technology company, announced today that its healthcare business has entered into a three-year collaboration to validate new therapeutic concepts in the field of oncology with Selvita, headquartered in Krakow, Poland. Financial details were not disclosed.

The aim of the collaboration is to deliver potential first-in-class small molecules as lead candidate drugs for multiple oncology indications. Both companies will contribute funding and resources to support the collaboration, as well as bring their expertise in target validation, bioinformatics, medicinal chemistry, in vitro and in vivo biology, and toxicology.

"We are excited about our new collaboration and to continue our productive relationship with Selvita and to build upon our collective efforts of the last two years,” said Andree Blaukat, Head of the Translational Innovation Platform Oncology at Merck. “We are making strong progress in the area of cancer metabolism, and remain focused on bringing innovative new therapeutic options to patients that have the potential to make a substantial difference in their lives."

This collaboration will steer a joined portfolio of discovery projects in a risk/reward sharing model and builds on the framework that the two companies have developed during a two-year partnership in cancer metabolism which began in 2013.

Under the terms of the new agreement, Merck will have an exclusive license to the joint intellectual property and Selvita will receive milestone payments and royalties upon successful development and commercialization of products by Merck. The collaboration consists of a joint research phase up to lead identification, after which Merck will further research and develop the projects on its own.

Krzysztof Brzozka, Selvita Chief Scientific Officer, added: “Collaboration between Merck and Selvita is an excellent example of a successful joint drug discovery platform where both parties contribute their expertise to identify and validate novel therapeutic targets, in parallel developing new compounds and advancing them towards clinical development. This sort of deep and intensive type of collaboration is at the core of Selvita’s vision of modern drug discovery.”

About Selvita
Selvita is a drug discovery company engaged in the research and development of breakthrough therapies in the area of oncology, as well as provision of integrated drug discovery services.
Selvita was established and 2007 and currently employs over 280 people, including 88 PhDs, with extensive experience in area of life sciences. Selvita has currently several projects at early or late discovery stage and is expected to move its first candidates to the clinic in 2016. Drug discovery clients of Selvita include more than fifty large and medium-sized pharmaceutical and biotechnology companies from USA and Europe. Selvita offices are located in Greater Boston Area, San Francisco Area, Cambridge, UK, San Bruno, California, and Krakow, Poland. The company is listed on the Warsaw Stock Exchange (WSE:SLV).

About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 40,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2014, Merck generated sales of € 11.3 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Contact

Natalia Baranowska
+48 784 069 418 
natalia.baranowska@selvita.com

Amsterdam, The Netherlands, November 2, 2015 / B3C newswire / -- Hercules Pharmaceuticals BV, a biopharmaceutical company developing an innovative treatment for women with Triple Negative Breast Cancer (TNBC), has been awarded a € 3,5 million Eurostars grant for the development of its lead drug CB7993113 for treatment of TNBC. The Eurostars grant will enable Hercules to advance CB7993113, a novel non-toxic targeted anti-cancer drug, through pre-clinical development towards clinical trials in cancer patients. The development work will be done by a Dutch-English-Finnish-Danish-French consortium of specialist life-science companies and with researchers at Boston University in the U.S.

Hercules’ lead product, CB7993113, attacks tumors in three synergistic ways. Firstly, by inhibiting the Aryl Hydrocarbon Receptor (AHR), CB7993113 blocks spreading of the tumor via a direct effect on AHR positive tumor cells. Secondly, it reduces the number and function of Cancer Stem Cells, which are a type of cancer cells that resist chemotherapy and often cause metastasis and relapse of cancer even after “successful” treatment. Thirdly, CB7993113 may enhance tumor-specific immune response, which are dampened by the cancer itself. In this regard, CB7993113 is likely to act in a fashion similar to that of Check-Point inhibitors, a class of highly effective anti-cancer drugs. CB7993113 has shown efficacy in in-vivo cancer models in which it dramatically improved survival from 25% to 90% and inhibited tumor metastasis. Once proven to be safe for human use, the drug may be tested in patients with carcinomas including TNBC, for which there is a critical unmet medical need.

Professor David Sherr, founder of Hercules comments: “I’m delighted about this grant which allows us to further develop our novel approach to treating cancer. Our lab demonstrated that the AhR plays a crucial role in driving cancer cell metastasis, resistance to therapy, and suppression of tumor-specific immune responses. Therefore we are fully committed to our mission of developing drugs targeted to this cancer Achilles heel, that would offer hope for the treatment of some of the most aggressive cancers including triple negative breast cancer.”

 
About Hercules
Hercules was founded in 2013 to develop and commercialize the invention of Professor David Sherr, an international key opinion leader in the field of cancer at Boston University. Professor Sherr demonstrated that the Aryl Hydrocarbon Receptor plays an important role in the occurrence and progression of cancer. He also discovered that blocking the Aryl Hydrocarbon Receptor with a small molecule, non-toxic drug is a promising and novel way to treat aggressive carcinomas, including Triple Negative Breast Cancer. Hercules is incorporated in The Netherlands and is managed by the team of DDF Ventures with the scientific support of Professor Sherr.

Shareholders of Hercules are Amsterdam based DDF Ventures; Professor Sherr; Boston University; Boston Medical Center and Northeastern University.

About DDF Ventures
Amsterdam, The Netherlands, based DDF Ventures is majority shareholder of Hercules and employs its team of experienced life-science executives to manage Hercules. DDF Ventures holds significant equity positions in five early stage life-sciences companies, four of which are actively managed by the DDF Ventures team.

About Eurostars
Eurostars grants support international European innovative projects led by small- and medium-sized enterprises. Eurostars is a joint programme between EUREKA and the European Commission, co-funded from the national budgets of 34 Eurostars Participating States and Partner Countries and by the European Union. The budget for the period 2014-2020 is €1.14 billion.

The successful grant application was written by Catalyze, the Amsterdam-based financing consultancy company. Catalyze was also instrumental in building the international consortium of participating companies.

Contact

Bart Wuurman
CEO
Joop Geesinkweg 167
1114 AB Amsterdam, The Netherlands
Tel:    +31 20 72 34 400
Mob: +31 64 66 23 735
bart.wuurman@hercules-pharma.nl
www.hercules-pharma.nl