Munich, Germany, April 24, 2014 / B3C newswire / - Isarna Therapeutics GmbH, a leader in TGF-β therapeutics, today announced that it has raised Euro 5.5 million ($7.6M) in equity from its current investors including AT NewTec, Global Asset Funds, and MIG Fonds. The company also announced that Elizabeth Czerepak has joined Isarna’s management team as Chief Financial Officer and Chief Business Officer to lead the company’s new office location in New York City.

"Isarna is committed to its leadership in TGF-β and we see Elizabeth’s addition to our management team, as well as our expansion into the U.S., as key strategic steps toward building our presence in the global biotech industry,” said Dr. Philippe Calais, Chief Executive Officer at Isarna Therapeutics. “We are grateful for the continued support and confidence from our investors as we work to create Isarna’s future.”

“Isarna’s goal of unlocking the power of TGF-β for cancer immunotherapy and as an innovative approach for treating ocular diseases and fibrosis is tremendously exciting and I am excited to join this impressive team and make an impact toward achieving success for the company,” added Ms. Czerepak.

Elizabeth Adkins Czerepak, MBA, brings to Isarna twenty-one years of pharmaceutical and biotechnology leadership experience and nine years as a venture capital investor at JP Morgan and Bear Stearns. Ms. Czerepak has served in executive-level finance, licensing and corporate development positions, most recently as Chief Financial Officer and Principal Accounting Officer at Cancer Genetics, Inc. (CGIX), that she took public on NASDAQ and for which she raised three rounds of public financing totaling $69M. Prior to CGI, Elizabeth worked at BASF Pharma (Knoll), Hoffmann-La Roche and Merck & Co., MBA,

 
About Isarna Therapeutics
Isarna Therapeutics has an unmatched commitment to developing TGF-β inhibitors that stimulate the human immune system to effectively fight cancer and other diseases. We are advancing a unique pipeline of novel oligonucleotides and combination modalities to transcend clinical response and improve patient outcomes.  

Isarna Therapeutics
Leopoldstr. 254-256 | 80807 Munich | Germany
415 Madison Avenue | Suite 1420 | New York, NY 10017 | USA


Contacts

Dr. Andrea Kottke
Head Medical Affairs and Communication
Isarna Therapeutics
media@isarna-therapeutics.com
+49 151 11 354 185

or

Gretchen Schweitzer
MacDougall Biomedical Communications
gschweitzer@macbiocom.com
+49 172 861 8540

Dresden, Germany, May 5, 2014 / B3C newswire / – Cenix BioScience GmbH (Cenix), a leading preclinical contract research provider and technology developer specialized in RNAi-based genomics and high content screening-driven pharmacology, today announced that is has signed a research service agreement with Bayer Pharma AG (Bayer).

Under the agreement, Cenix will undertake a target discovery project for an undisclosed disease indication by applying its longstanding industry-leading expertise in high throughput RNAi for genome-scale screening in advanced cell models.

Financial terms were not disclosed.

About Cenix BioScience
With operations in Germany and the U.S., Cenix BioScience conducts contract research and develops new reagent technologies focused on a wide array of preclinical cell-based and in vivo applications including RNAi-based gene silencing, miRNA modulation, compound testing, advanced genomics analyses and high content screening to accelerate drug discovery and development. Now in its 15th year, Cenix has established unrivaled scientific and commercial track records in this field, successfully advancing therapeutic programs for numerous industry and academic partners in a broad range of disease fields. This success, illustrated by a high rate of repeat business from top clients, is driven by the consistent application of industrial best practices through highly customized, multi-staged projects carefully designed for maximal strategic value and accountability, with minimized risk and full data transparency. More information: www.cenix.com

Contact
Dr. Christoph Sachse
Director Cell-based Services
E: info@cenix.com
W: www.cenix.com

Cenix and the Cenix BioScience logo are registered trademarks owned by Cenix BioScience GmbH.

Regensburg, Germany, May 8, 2014 / B3C newswire / – Lophius Biosciences GmbH, a privately held biotech company focusing on the development and marketing of innovative T cell based research tools and diagnostic systems for functional assessment of disease-reactive T cells, today announced that the company has secured a EUR 2,0 Million financing round. This financing was led by one of the current main investors, VRD GmbH, Heidelberg, Germany with participation of two of the existing investors one of which S-Refit AG, Regensburg. The current investment will support the continuation into a commercial operation to further advance the clinical studies of Lophius’ flagship product T-Track® CMV for the various clinical indications and to enable the further development of the pipeline products T-Track® TB (Tuberculosis) as well as T-Track® MS (Multiple Sclerosis).

With the secured financing, Dr. Robert Phelps, previously Lophius’ Director Business Operations, has been appointed as new Chief Executive Officer and the current CEO, Prof. Dr. Ralf Wagner, has been elected as Chairman of the Board, replacing Mr. Bertram Gilka-Bötzow, now one of the board’s Vice Presidents. Prof. Wagner and Dr. Phelps will work closely together to further drive the conversion of a previously research and development focused company into a commercial organization.

“The current round of financing and management change are supporting a long-term strategy to capitalize on the company's future growth opportunities and goals and its transition into a commercial operation” said Prof. Dr. Wagner. “I am excited to take on this new challenge and to work with Ralf and a team of highly skilled specialists and researchers. I look forward to increasing our market presence and continuing to aggressively pursue additional pathways for market expansion of our T-Track® products," added Dr. Phelps.

Prof. Dr. Wagner, now elected to become Lophius’ Chairman of the Board, joined Lophius Biosciences in January 2013 as CEO. During his leadership, he instrumentally contributed to the further development of all parts of the company – from human resources to quality management, from research activities up to the implementation of new entities such as manufacturing, clinical trial coordination or sales. “With his professional working attitude, his excellent management skills and his profound scientific and economic background, Ralf has tremendously contributed towards advancing Lophius to a highly innovative and at the same time commercially oriented organization. We’ll hear more about most recent progress made under his leadership in the weeks to come. We are very happy that Prof. Dr. Wagner will continue to support Lophius in his new role as Chairman of the Board”, said Mr. Gilka-Bötzow.

About Lophius Biosciences
Lophius Biosciences GmbH, a German biotech company, is focusing on the development and marketing of innovative T cell based diagnostic systems for diagnosis and immunomonitoring. The Company’s flag ship product is T-Track® CMV, a diagnostic system intended to determine the functionality of the cell-mediated immune response in cytomegalovirus (CMV) seropositive transplant patients who undergo an immunosuppressive therapy. With its innovative products, the Company aims to significantly improve therapy control and personalized treatment of patients in the area of transplantation medicine, infectious and autoimmune diseases. 

Dr. Robert Phelps joined Lophius Biosciences in October 2013 as Director Business Operations and previously spent 14 years in various business development, licensing, and marketing and sales roles in the biotech and pharma industry.

Prof. Dr. Ralf Wagner joined Lophius in January 2013 as CEO. Prior of that, he served almost 13 years as CEO of GeneArt AG, a German biotech company founded Nov 1999 as spin-off from the University of Regensburg, that went public in 2006 and was acquired by Life Technologies in 2010. Besides to his roles in the biotech industry, he is Professor for Medical Microbiology and faculty member at the University of Regensburg.

Contact:

Dr. Robert Phelps
Lophius Biosciences GmbH
Josef Engert Str. 13
93053 Regensburg
Tel.: +49 941 630 9191 80
Email: info@lophius.com

Research Triangle Park, North Carolina, USA, May 13, 2014 / B3C newswire / - KBI Biopharma, Inc. (KBI) has signed an agreement with Merck & Co., Inc. (known as Merck in the United States and Canada) to acquire Merck’s microbial process development and manufacturing operations in Boulder, Colorado, effective May 1, 2014.  Under the agreement, KBI will provide ongoing development and manufacturing services to Merck, as well as to third party customers.

“We are very pleased to continue to advance our partnership with Merck, and to welcome this very highly regarded team of scientists in Boulder to the KBI team,” stated Joe McMahon, KBI’s President and CEO.  “KBI will now offer expanded microbial development and manufacturing services up to 1500L scale, as well as continuing to offer our current full range of process development, analytical and formulation development and mammalian manufacturing services up to 2000L.”

KBI will also continue to support other ongoing drug development programs for Merck from its two North Carolina facilities.

To date, KBI has helped to advance more than 220 molecules in 55 unique health indications for over 170 clients around the world.  With the addition of these expanded microbial capabilities, KBI is well positioned to continue to accelerate an even broader range of drug development programs for its global client base.

About KBI Biopharma, Inc.
KBI is a contract development & manufacturing organization driven to improve the quality of human life by serving their biopharmaceutical clients in the accelerated development of innovative medicines for patients around the world.

To date, KBI has served over 170 clients globally and offers an extensive suite of expert development and manufacturing services through an agile, customer-focused approach. Clients include global pharmaceutical and biotechnology companies as well as academic and non-profit organizations.

Contact

Andrew Cohen
KBI Biopharma Inc.
Phone: +1 919-479 9898
acohen@kbibiopharma.com

Copenhagen, Denmark, May 21, 2014 / B3C newswire / - Brian Zambrowicz, Ph.D. is one of the co-founders of Lexicon Pharmaceuticals Inc. and has served the company as Executive Vice President and Chief Scientific Officer since 2007. Dr. Zambrowicz has been instrumental in setting the overall scientific direction of the company, including the development of Lexicon's proprietary gene knockout technology and small molecule drug discovery pipeline.  Under his direction, Lexicon has knocked out and analyzed nearly 5,000 genes resulting in the identification of more than 100 potential new drug targets. He has been involved in the discovery and development of Lexicon’s portfolio of clinical stage programs, including LX4211, a dual SGLT1 and SGLT2 inhibitor for Type 1 and 2 diabetes, and telotristat etiprate for carcinoid syndrome. Prior to joining Lexicon, he served as a National Institutes of Health postdoctoral fellow at the Fred Hutchinson Cancer Research Center in Seattle, Washington.  Dr. Zambrowicz received his B.S. in biochemistry from the University of Wisconsin, Madison and his Ph.D. in biochemistry from the University of Washington, Seattle.

Nuevolutions Board of Directors is composed as follows:

• Stig Løkke Pedersen, Chairman of the Board.
• Viktor Drvota, Director, SEB Venture Capital, Head of Investment Area, Life Science.
• Søren Lemonius, Director, Partner, Sunstone Capital.
• Jonas Brambeck, Director, Investment Manager, Industrifonden.
• Professor Dr. Jutta Heim, Director, Senior Scientific Advisor to the Board
• Dr. Brian Zambrowicz, Director, Senior Scientific Advisor to the Board
• Stefan Olofsson, Observer, SEB Venture Capital Investment Manager, Life Science and Technology.

“We are very pleased that Brian has decided to join us as Director and Scientific Advisor, said Alex Gouliaev, CEO of Nuevolution A/S. “Brian’s entrepreneurial experience and life science expertise, will strongly support Nuevolution to successfully develop its pipeline within oncology and inflammation”.

Stig Løkke Pedersen, Chairman of Nuevolution A/S said: “Nuevolution A/S has successfully developed and commercialized its Chemetics® technology to a very advanced level, and is progressing its own pre-clinical pipeline. We are convinced that Brian’s expertise in drug discovery and commercialization thereof will add important expertise to the Board of Directors”.

In June 2012, Nuevolution announced a new financing round of € 11 Million to establish an internal pipeline of drug candidates addressing important targets within oncology and inflammation. The lead programs are now in the final optimization stage. In February this year, Nuevolution licensed a small molecule program targeting an undisclosed intracellular protein-protein interaction, to MSD.

Nuevolution’s powerful lead discovery platform is currently being applied against a vast number of therapeutically important targets within oncology and inflammation and several programs are progressed through pre-clinical development by Nuevolution as well as in partnerships to deliver new medication for diseases with an unmet need.

Brian Zambrowicz commented further: “The Nuevolution Chemetics® platform has interested me for many years and I look forward to working with the Nuevolution board and management team to discover novel small molecule drugs using the strengths of this technology.”

In parallel with delivering novel small molecule compounds alone as well as in collaboration with pharmaceutical companies, Nuevolution will continue to form partnerships around its platform technology, similar to the agreement Nuevolution made with Novartis in January this year.

About Nuevolution
Nuevolution is a leading small molecule lead discovery company founded in 2001 and based in Copenhagen, Denmark. The company has developed Chemetics®, a unique, patent protected hybrid of proven wet chemistry and molecular biology, which represents the ultimate fragment, based drug discovery technology. 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 of these, facilitating the identification of potent drug leads at unprecedented speed and scale.

Nuevolution partners its technology with pharmaceutical and biotechnology companies, and has entered into drug discovery agreements with Merck, Novartis, Boehringer Ingelheim, Cancer Research Technology and The Institute of Cancer Research. Furthermore, Lexicon Pharmaceuticals, GlaxoSmithKline and Novartis have entered technology licensing agreements with Nuevolution. Nuevolution participates in a scientific joint venture consortium (Nuevolution, Duke University, Howard Hughes Medical Institute, Lexicon Pharmaceuticals) focusing on GPCR’s, and Nuevolution is currently in the optimization phase for compounds identified under a joint venture consortium between Nuevolution, EpiTherapeutics, ExpreS2ion Biotechnologies and BRIC focusing on epigenetics. Nuevolution has demonstrated the power of Chemetics® by identification of highly potent and drug like novel ligands with the potential to address major unmet medical needs across a range of therapeutic areas and target classes. Nuevolution’s internal programs are focused on therapeutically important targets within inflammation and oncology. Nuevolution is a privately owned company by key Scandinavian investors, including SEB Venture Capital, Sunstone Capital, Industrifonden, SLS Invest, Novo Ventures and Innoventus Life Sciences.

Chemetics® is a registered trademark of Nuevolution.

Chemetics® is a patented technology of Nuevolution: EP1402024, US7,727,713, EP1487978, US7,413,854, EP1756277, EP1608748, US 7,915,201, EP1558744, AU2003273792, CN-ZL20038010476, HKHK1082742, IN213390, IL167531, JP4895608, ZA2005/02624, NZ538993, SG111515, US8,206,901, US7,704,925, EP1957644,EP07114663.3, EP10184311.8, US12/330,709, EP08169346.7, US12/179,323, EP03766117.0, US10/523,006, US10/539,288, US13/179,283, EP09154197.9, AU2011226815, CA2,544,153, CN201210222023.8, EP10183942.1, EP10184069.2, HK11107861.8, HK11107866.3, IL207672, IL207673, IN178/MUMNP/2007, JP2010-226107, JP2013-155967, US11/402,957, US13/455,223, US10/572,644, EP10192716.8, EP10192717.6, US12/095,778, EP09765460.2, US12/999,267, EP11720372.9, IN9924/DELNP/2012, US13/641,588.

 
For further enquiries about Nuevolution please contact:

Nuevolution A/S

Alex Haahr Gouliaev, CEO
Phone: +45 7020 0987
ahg@nuevolution.com

Stig Løkke Pedersen, Chairman
Phone: +45 4086 4151
slp@stigloekkepedersen.dk

Groningen, the Netherlands, May 22, 2014 / B3C newswire / - Biotechnology company Mucosis B.V. today announced that it has received an innovation credit line of up to €5 million from the Netherlands Enterprise Agency, an agency of the Dutch Ministry of Economic Affairs.

Mucosis will use these funds to further advance the clinical development of its proprietary SynGEM® prefusion F RSV vaccine candidate through human proof-of-concept studies. These studies aim to demonstrate both safety and protection against a challenge with RSV in healthy volunteers.

"We are delighted to have the support of the Dutch government in such an important disease area. Combined with our recently announced strategic partnership with BCHT of China and new investment round, we have now raised over €10 million in the first half of 2014. Advancing the SynGEM® program to human clinical trials through these funds will create a substantial company value inflection point in the near term", said Thomas Johnston, CEO of Mucosis.  "Additionally, we see this significant funding as a further validation of our clinical-stage Mimopath® platform and its potential to combat the most challenging of infectious diseases.”

About Mucosis 
Mucosis B.V. is a clinical-stage Dutch biotechnology company with a proprietary platform technology, Mimopath®, on which it develops novel vaccines using various routes of administration including those that provide additional protection in the mucosa, the site where over 90% of pathogens enter the human body. Mucosis’s lead product is SynGEM®, a stabilized prefusion F protein recombinant vaccine to prevent RSV infection in various target groups. In addition, the company has developed PneuGEM®, a vaccine to prevent diseases caused by pneumococcal bacteria and FluGEM®, a vaccine to prevent influenza which served as a successful Mimopath® platform proof of concept through human clinical testing.

About Mimopath® technology 
The Mimopath® technology is based on Lactococcus lactis, a Generally Recognized As Safe (GRAS) bacterium commonly used in the food industry. Mucosis has developed a robust proprietary technique to formulate the L. lactis bacteria into non-living bacterium-like particles (BLPs) that can be covered with antigens from viral, bacterial, parasitic or tumor origin. BLP-based vaccines are particularly suitable to administer into the nose or mouth, without the need for a needle. Such mucosal vaccines have been shown to raise protective immunity by activation of both the innate and the adaptive immune system.

About SynGEM®
SynGEM®, Mucosis’s lead vaccine candidate that is currently completing preclinical studies, is being developed in cooperation with corporate, governmental and non-governmental partners across the globe. SynGEM® is designed to prevent infections with Respiratory Syncytial Virus (RSV), which affect over 60 million people worldwide ranging from the very young to the elderly with more than one million hospitalizations and 160,000 deaths annually. The unique stabilized RSV prefusion F protein in SynGEM® displays the epitopes thought to be most important for optimal virus neutralization and is suitable for use in different formulations and administration routes to efficiently address various target groups. An RSV vaccine does not yet exist.

Contact

Thomas Johnston 
CEO Mucosis 
+31 (50) 8200050
info@mucosis.com
www.mucosis.com

Companies Advance Multiple Co-discovery Programs for First-in-class Targets in Oncology

Cambridge, MA, USA and Krakow, Poland, May 22, 2014 / B3C newswire / - H3 Biomedicine Inc., a biopharmaceutical company specializing in the discovery and development of precision oncology treatments, and Selvita (PL: SLV), one of the largest drug discovery companies in Eastern Europe, announced today that they have achieved the first research milestone in their strategic collaboration to develop breakthrough precision medicines for cancers. The companies have validated the importance and druggability of a kinase target in a specific genetic context and have generated multiple novel chemical series against this target. The companies expect the first candidate molecule originating from the collaboration to move to IND-enabling studies in 2015.

Markus Warmuth, President and Chief Executive Officer of H3 Biomedicine, commented: “Teaming up with Selvita has allowed us to validate multiple targets with hypotheses based on genetic changes in cancer. Through systematic validation of these targets, H3 and Selvita together are solidifying their understanding of their biological mechanisms and, in parallel, are developing novel chemical matter that modulates them. We have made quick progress and will continue to aggressively pursue the programs toward clinical development.”

Krzysztof Brzozka, Selvita Chief Scientific Officer, said, “Selvita’s most advanced internal programs focus on kinase inhibitors in oncology and the work on the novel target follows our previous successful discovery efforts on PIM/FLT3 and CDK8. Since the start of our collaboration with H3 in September 2013, our teams have worked very well together, complementing each other’s efforts. We hope to see the first small molecules originating from the collaboration in the clinic in 2016”.

H3 Biomedicine will provide a milestone to Selvita in consideration of Selvita’s achievement of the first research goal in the project. The companies are not disclosing the amount.

 
About H3 Biomedicine Inc.
H3 Biomedicine is a biopharmaceutical company specializing in the discovery and development of precision oncology treatments. Leveraging an unprecedented collaboration with Eisai, which provides research funding and access to the capabilities and resources of a global pharmaceutical company, H3 Biomedicine combines long-term vision with operational independence. Using modern synthetic chemistry, chemical biology and human genetics, the company seeks to bring the next generation of cancer treatments to market with the goal of improving the lives of patients. H3 Biomedicine is based in Cambridge, Massachusetts.

About Selvita
Selvita is a Polish biotechnology company engaged in the discovery and development of breakthrough medicines to treat oncology, CNS and autoimmune disorders, as well as provision of drug discovery services. It was established in 2007 and currently employs 195 people, including 63 PhDs. Selvita has currently several internal projects at early or late discovery stage and is expected to move its first candidates to the clinic in 2015. The most advanced programs at Selvita are SEL24, a pre-clinical PIM/FLT3 kinase inhibitor, with multiple indications in hematopoietic tumors and SEL120, first-in-class small molecule inhibitor of cyclin dependent kinase CDK8. Other innovative projects currently in development include SEL141, an early stage discovery program of DYRK1A kinase inhibitors with therapeutic potential in the treatment targeting Alzheimer's disease and Down syndrome, SEL201 – novel small molecule MNK1/2 inhibitors in oncology, cancer metabolism platform and inflammasome platform.  Drug discovery clients of Selvita include more than fifty large and medium-sized pharmaceutical and biotechnology companies from USA and Europe. Selvita is listed on the NewConnect market of the Warsaw Stock Exchange in Poland (SLV).

 
Media Contacts:

Mike Beyer
Sam Brown Inc.
(773) 463-4211
beyer@sambrown.com

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

Planegg, Germany, May 23, 2014 / B3C newswire / - Mr. Jens Klein was appointed managing director of AMSilk GmbH, Planegg, as of March 15, 2014. He succeeds Mr. Axel Leimer, AMSilk’s former CEO, who had successfully run the company for six years until February 28, 2014.

As CEO Mr. Klein is responsible for the strategic positioning and the future growth of the company. 

Most recently Mr. Klein worked for Evonik Industries AG. In 2011 Evonik acquired nanoresins AG and Hanse Chemie AG. Mr. Klein was a member of the executive committee of both companies since 2006. In these functions he had a significant impact on the growth of both companies, the integration of new technologies, the optimization of manufacturing processes as well as the international expansion.

Previously, he was a member of the executive board of Mulligan BioCapital AG, Hamburg and Munich. Mulligan used to be a long-term investor in medical technology, biotechnology and high technology enterprises in the US and Europe. Among other responsibilities Mr. Klein shared responsibilty for the initial public offerings of two portfolio companies as well as several trade sales to strategic investors. Prior to joining Mulligan he was the commercial head and managing director of subsidiaries of Fresenius AG, Bad Homburg.

With regard to his new tasks at AMSilk GmbH Mr. Klein stated, „AMSilk has the unique potential to market spider silk protein across various application areas. The key goal is to position the product successfully in high revenue markets and to generate  additional collaborations and licensing deals.“.

Mr. Helmut Jeggle, managing director of AT Newtec GmbH and representative of AMSilk’s largest shareholder commented, „Our thanks go to Mr. Leimer for his magnificent performance ever since the founding of AMSilk in 2008 and for his outstanding personal commitment that allowed him to take AMSilk to where it is today. We also wish Mr. Klein our best for the challenges ahead.“

Dr. Matthias Kromayer, chairman of the board of AMSilk GmbH and member of the executive committee of MIG Verwaltungs AG mentioned, „We feel enthusiastic that we managed to hire Jens Klein who happens to be not only an expert with comprehensive industry knowledge but also a man who can skillfully formulate ambitious goals and then turn them into reality. Beyond this he combines extensive experience in strategically positioning companies, building sales organizations, managing corporate finances and working with the financial markets with his broad skills and know-how in high technology markets."

About AMSilk
AMSilk is a privately-held company that develops, manufactures and markets novel cosmetics, medical technology and drug delivery products as well as technical fibers on a worldwide basis.

Spider silk has attracted man's interest for thousands of years, mainly due to its toughness and elasticity. The silk is biocompatible and can be used in formulations for specialized coatings, films, nonwovens and in pharmaceuticals. Spider silk has evolved over millions of years resulting in a combination of properties that far exceed any man-made material. AMSilk has developed a proprietary process for producing spider silk on an industrial scale.
AMSilk was founded in 2008 as a spin-off of Technische Universität Munich and is located at the IZB in Planegg near Munich. AMSilk's investors are Munich-based MIG Funds and AT Newtec GmbH (a company of the Strüngmann family office). Projects are partially funded by grants from the German Federal Ministry of Education and Research as well as the Bavarian Ministry of Economic Affairs, Infrastructure, Transport and Technology with project management provided by the PTJ and VDI.

AMSilk is a registered trademark of AMSilk GmbH, Germany.

Contact

AMSilk GmbH
Am Klopferspitz 19 im IZB
82152 Planegg; Germany
Phone: +49 (0)89 38156-4430
Email: pr(at)amsilk.com

Trial Results Demonstrate Safety and Therapeutic Benefits of Antibody

Mainz, Germany, May 27, 2014 / B3C newswire / - Ganymed Pharmaceuticals AG announced today that its Ideal Monoclonal Antibody IMAB362 demonstrated significant safety and therapeutic benefits in a Phase IIa trial in gastroesophageal cancer (GEC). The trial involved 54 patients who had exhausted all other therapeutic options.

“This study establishes IMAB362’s high potential as novel treatment for patients with advanced gastroesophageal cancers,” commented Professor Martin Schuler, West German Cancer Center, Essen, who coordinated the study. “The clinical activity seen in this heavily pretreated study population is very promising for an antibody monotherapy.”

In the trial, patients with CLDN18.2-positive, metastatic, refractory or recurrent advanced GEC (NCT01197885) received 600 mg/m2 IMAB362 as a monotherapy every 2 weeks for 5 cycles. Final analyses indicate that partial response and stabilization of disease was achieved following IMAB362 treatment. A per protocol set of 21 patients showed a Disease Control Rate of 48%: Of these patients, 19% underwent partial remission and 29% achieved stable disease state according to the Response Evaluation Criteria In Solid Tumors (RECIST).

The median Progression Free Survival (PFS) was 102 days (95% CI), ranging from 70 to 146 days. Patients with clinical benefits had a median PFS of 262 days as compared to a median PFS of 70 days for patients with disease progression. Nine patients continued treatment beyond 5 cycles due to clinical benefit and one patient has been benefiting from treatment for over 16 months.

IMAB362 was safe and well tolerated during the study with nausea and vomiting being the most frequent drug related adverse event.

“I find it exciting that even as single agent, IMAB362 brought therapeutic benefits to patients to whom we have no other therapeutic options to offer,” said Professor Emeritus Christoph Huber, Co-founder and Supervisory Board member of Ganymed. “We are looking forward to seeing the results of the ongoing randomized Phase IIb study that includes 210 patients with gastroesophageal cancer receiving IMAB362 as first-line therapy in combination with chemotherapy. Based on preclinical data a synergistic effect of adding IMAB362 to best standard care is expected.”

About IMAB362
IMAB362 is a first-in-class antibody that is selective and specific for the tight junction protein CLDN18.2. This unique target is present only on differentiated cells of the stomach mucosa and is absent from all other healthy tissues. CLDN18.2 is however expressed in up to 80% of gastrointestinal adenocarcinomas, 60% of pancreatic tumors as well as in subsets of lung, ovarian and bile duct cancers. This makes IMAB362 the first antibody that is cancer cell selective while having little or no effect on healthy cells, thus reducing the risk of side effects. This represents a great advantage over other anticancer therapies that target both cancerous and healthy cells resulting in unwanted side effects.

About Gastroesophageal Cancer
More than a million individuals worldwide are diagnosed with gastroesophageal cancer each year. The majority of cases are diagnosed at an advanced stage which drastically reduces the effectiveness of current therapies resulting in a five year survival rate of less than 25%. Major unmet medical needs include lack of safe and effective systemic first-line therapy, poor control of metastatic tumors and a complete absence of second-line treatment options. Consequently, the need for earlier diagnosis and more effective therapies is extremely high.

About Ganymed Pharmaceuticals AG
Ganymed Pharmaceuticals AG is a biopharmaceutical company with the mission of revolutionizing cancer treatment by developing a new class of therapeutic drugs called Ideal Monoclonal Antibodies (IMABs). IMABs are unique in that they are highly selective for proteins which are present on tumor cells, but do not bind to healthy cells. This unmatched tumor cell specificity makes IMABs cancer cell selective allowing them to efficiently kill tumor cells without harming normal healthy tissues. They can thus be administered at optimal dose and have a broad therapeutic window with reduced risks of side effects.

Ganymed’s lead program, IMAB362, is in advanced Phase II testing for gastroesophageal cancer. IMAB362 binds to the tight junction protein Claudin-18.2 which is expressed in up to 80% of gastroesophageal adenocarcinomas, 60% of pancreatic tumors as well as in other various solid tumors.   

Ganymed is also developing IMAB027, a monoclonal antibody targeting Claudin-6 which is absent in healthy adult organs, but is expressed in a wide range of solid cancers, including testicular, ovarian, uterine, and lung cancers. IMAB027 is presently in Phase I/II clinical development for ovarian cancer.

Ganymed is a private company that was founded in 2001 as a spin-off from the Universities of Mainz and Zurich. Its majority shareholder is ATS Beteiligungsverwaltung GmbH. Other investors include Future Capital AG, MIG Fonds, FCPB Gany GmbH, and private individuals.

Contact Information

Dr. Luc St-Onge
Business Development
Ganymed Pharmaceuticals AG
Freiligrathstrasse 12
55131 Mainz
Germany
Tel.: +49 (0)6131 1440 100
e-mail: pr@ganymed.ag

Media Contact

Frank Butschbacher, CIR
Investor Relations & Communications
Mobile: +43-650-78 44 940
Office: +43-2236-892036
e-mail: office@butschbacher.net

Maastricht, The Netherlands, June 2, 2014 / B3C newswire / – PharmaCell B.V. a leading Contract Manufacturing Organization for Cellular Therapies and Regenerative Medicine in Europe, announced today that it finalized its purchase of the state-of-the-art cell therapy production facility from TiGenix NV. TiGenix, a leading European cell therapy company has been producing its marketed product for cartilage repair, ChondroCelect® at the site in Sittard-Geleen, close to Maastricht (The Netherlands), since the beginning of 2013.

ChondroCelect® will continue to be manufactured at the facility as before under a long-term CMO agreement with TiGenix. PharmaCell has acquired the facility, including its qualified team of employees in Production, QC, QA and other functions that bring many years of experience in cell therapy manufacturing into the organization.

Following the acquisition, PharmaCell will continue to operate its Maastricht facility in addition to the site at Sittard-Geleen. The Maastricht facility offers non-GMP process development and flexible GMP-production facilities for early- to mid-stage clinical trials in cell therapy. The Cell Manufacturing Facility Geleen will offer clients the opportunity to support late stage clinical trials and commercial production for the industry. Taken together, PharmaCell offers a comprehensive contract manufacturing service package for cell therapy companies along the development pathway from translational work all the way to the commercial stage. With both TiGenix (ChondroCelect®) and Dendreon Corporation (for Provenge®) as partners, the company has two commercial cell therapy products under contract. In addition, work is ongoing on early stage clinical trials and translational projects.

Alexander Vos, CEO of PharmaCell B.V. said: “We are very pleased to have concluded the transaction with TiGenix. We believe PharmaCell now offers a unique manufacturing platform in Europe to support the growth of the cell therapy and regenerative medicine industry in future years. We look forward to discuss plans for a future collaboration with interested parties.”

About PharmaCell
PharmaCell is a leading European-based CMO active in the area of cell therapy and regenerative medicine. PharmaCell has experience in supporting Phase I through Phase III clinical trials and early commercial manufacturing in cell therapy in terms of manufacturing, QC, storage, in-outgoing logistics and product release through its in-house QPs. PharmaCell is exclusively focused on providing contract services in the area of human cell therapy. Its services also include process and assay-development to ensure GMP compliance, robustness and scalability of cell therapy manufacturing processes.

About TiGenix
TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands).

 
For more information:
Alexander Vos
Chief Executive Officer
a.vos@pharmacell.nl
+31 43 35 09910

Soenke Brunswieck, PhD
Director Business Development
s.brunswieck@pharmacell.nl
+31 43 35 09910

Innovative polyethylene film sets new benchmark

Goettingen, Germany and Aubagne, France, June 2, 2014 / B3C newswire / –Sartorius Stedim Biotech, a leading global supplier of the biopharmaceutical industry, is introducing a brand-new, scalable range of single-use bags. Its completely new developed product family Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using just the one innovative polyethylene film. The innovative concept of the Flexsafe family addresses key industry requirements for future-proof single-use manufacturing of commercial vaccines and drugs.

Flexsafe is based on a multilayer, proprietary polyethylene (PE) film, called S80, and has been developed in close collaboration with resin and film suppliers. A standardized cell growth assay has been used to optimize film formulation, determine the operating ranges for extrusion, welding and gamma-irradiation processes and to establish specifications and process controls.

Flexsafe ensures excellent and reproducible cell growth behavior of the most sensitive cell lines. The optimization of the resin formulation, the complete control of raw materials, the extrusion process and the bag assembly guarantee lot-to-lot consistent cell growth performance. With its robust 400 μm thick PE film, Flexsafe is the strongest and most flexible bag currently on the market. The bags enable safe and easy-to-use operation, even in the most demanding applications such as liquid shipping and large-scale stirred bioreactors.

Furthermore, batch-to-batch consistent extractables and leachables profiles support drug manufacturers throughout the entire lifecycle of modern biological treatments from clinical development to commercial supply many years after launch. Users can gain assurance that their initial extractable and leachable qualification work and data remain valid every time they operate their single-use Flexsafe bioprocess.

Assurance of supply, one of the most important aspects for manufacturers, is guaranteed as a result of long-term contracts with suppliers and business continuity plans with defined safety stocks and global manufacturing capabilities including resin manufacturing.

„Flexsafe represents a completely new generation of single-use bags. They offer our customers consistent cell growth as well as extraordinary robustness and flexibility. In addition a sustainable supply chain and consistent film throughout the entire manufacturing process is guaranteed. Every single one of these benefits sets a new benchmark. Being unique in all of them makes us very proud”, stated Stefan Schlack, Senior Vice President Marketing and Product Management at Sartorius Stedim Biotech.

Sartorius Stedim Biotech is launching Flexsafe RM bags (1L-200L) and small bags for validation purposes first. Bags for single use bioreactors BIOSTAT STR (50-2000L) and additional applications such as storage, mixing, shipping freeze and thaw will be rolled out step by step.

For high resolution, please click on image

For high resolution, please click on image

Caption:  Stefan Schlack, Senior Vice President Marketing and Product Management at SSB
For high resolution, please click on image

Photos | Links for downloading:

www.sartorius.com/fileadmin/media/global/company/flexsafe_2.jpg
www.sartorius.com/fileadmin/media/global/company/flexsafe_3.jpg
www.sartorius.com/fileadmin/media/global/company/flexsafe_4.jpg
www.sartorius.com/fileadmin/media/global/company/flexsafe_validation.jpg

Video Link:
www.sartorius-stedim.com/flexsafe

 
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 enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,300 people, and in 2013 earned sales revenue of 588.4 million euros.

 
Contact
Dominic Grone
Group Corporate Communications
Sartorius AG
Goettingen
Phone:+49 (0)551 308 3324
dominic.grone@sartorius.com
www.sartorius.com

Hannover, Germany, June 3, 2014 / B3C newswire / - Implandata Ophthalmic Products GmbH (Implandata) and Professor Peter Szurman, Head of “Section Experimental Ophthalmic Surgery” at Eye Hospital of University Tübingen, have started pre-clinical studies for the first implantable, permanent extraocular sensor, measuring intraocular pressure. The primary objective of the study is to show proof of concept and to demonstrate product and procedure safety. It is expected that the studies will provide additional design input, before early feasibility studies are started at human patients.

Whereas the company’s permanent intraocular pressure sensor is implanted at patients with pseudophakic eyes (glaucoma patients who undergo cataract surgery, or where cataract extraction has been done already before), the less invasive extraocular sensor implant measuring intraocular pressure can also address glaucoma patients with phakic eyes with healthy intraocular lenses.

The micro sensor of both versions allows close monitoring of the patients disease status and glaucoma therapy success. Through simple and more frequent measurements of intraocular pressure - which is the key parameter in glaucoma therapy - important information on therapy response is delivered to the ophthalmologists early on, enabling immediate glaucoma management adjustment, resulting in prevention of further vision loss due to uncontrolled intraocular pressure. Patients can perform pressure measurements with ease by themselves at home and under normal life conditions.

Study investigator Prof. Peter Szurman explains: “The implantable micro sensor will provide a new dimension in glaucoma monitoring, management and control. Furthermore this device is the next step to personalized glaucoma therapy and will be an effective tool to monitor intraocular pressure even out of medical practice hours and thus help us preventing progression of intraocular pressure-associated optic neuropathy which would further lead to permanent vision damage and blindness.” After the minimal invasive way of implantation the extraocular micro sensor is easy to handle for the health personnel and the patient and is a reliable way to measure intraocular pressure with high precision, comments Prof. Szurman.

After successful completion of the ARGOS-01 early feasibility study, Implandata is currently conducting ARGOS-02 clinical study with its implantable intraocular pressure sensor, with the goal to start the EC Conformity Declaration process in 2015. After completion of the pre-clinical study with the implantable extraocular sensor measuring intraocular pressure by end of 2014, Implandata and Prof. Peter Szurman will decide on next steps towards early feasibility studies of the extraocular placed sensor at glaucoma patients. Overall, Implandata is well underway to significantly broaden its product portfolio for telemetric measurement of intraocular pressure and improved glaucoma management.

About Implandata Ophthalmic Products GmbH
Implandata Ophthalmic Products GmbH is a privately held medical device company founded in 2010 and headquartered in Hannover, Germany. Implandata’s product for continuous monitoring of intraocular pressure will transform management of glaucoma patients, providing dramatically improved quality and quantity of intraocular pressure data, which is key for personalized therapy and therapy control. Remote patient management will increase glaucoma treatment efficiency and results in cost savings for all stakeholders.

Contact

Implandata Ophthalmic Products GmbH
Max G. Ostermeier
Kokenstrasse 5
30159 Hannover
Phone: +49 551 2204 2581
Fax: +49 511 2204 2589
mostermeier@implandata.com

Laupheim, Germany, June 6, 2014 / B3C newswire / – Rentschler Biotechnologie GmbH, a leading contract manufacturing organization (CMO) for the development and production of biopharmaceuticals, announce the addition of a 2,000 L single-use bioreactor to its facility in Laupheim. The expansion is anticipated to be fully operational end of the first quarter of 2015.

The new 2,000 L single-use bioreactor will supplement two existing 1,000 L single-use bioreactors already in operation and will double the total single-use production capacity.  

“We see an increasing need for production capacity in the mid-scale. The expansion will allow us to match the growing demands of our clients for all clinical phases. The addition of the 2,000 L single-use bioreactor will increase our flexibility to serve the market with either stainless steel or single-use technology as the client requires”, explains Frank Ternes, Chief Business Officer at Rentschler. 

In 2012, Rentschler received the “Facility of the Year Award” for its flexible, multi-product 1,000 L manufacturing facility designed to minimize manufacturing costs and product cycle times. Single-use equipment reduces contamination risks and permits a faster product turnaround with a shortened setup time and hence increases the capacity utilization. The facility features a flexible space concept comprising four independent, connectable, multi-purpose clean room suites. The new 2,000 L single-use bioreactor seamlessly integrates in this proven facility concept.  

Rentschler is one of the first CMOs having established a fully disposable process concept and already has more than three years of experience with this system. 

 
About Rentschler
Rentschler is a CMO with over 35 years proven track record in biopharmaceuticals. Focused on the utilization of mammalian cell lines, Rentschler’s long experience covers the development and production of recombinant proteins in compliance with international GMP standards. Rentschler’s customized solutions range from supporting drug candidate selection, cell line and process development capabilities as well as GMP production to comprehensive analytics and fill & finish. Rentschler’s state-of-the-art manufacturing facility includes bioreactors up to 3,000 L and aseptic filling lines for vials (including lyophilization) and prefilled syringes. The long-term experience with international regulatory affairs and authorities complements the offerings. Rentschler’s full-service concept allows flexibility on the individual project requirements.

Contact 

Dr. Marion Schrader
Senior Director Marketing
Rentschler Biotechnologie GmbH
Tel.: +49 (0) 7392 701 491
Marion.Schrader@rentschler.de

Deqing, China, June 6, 2014 / B3C newswire / - Shuwen Biotech Co. Ltd., a diagnostic company focused on licensing, developing and commercializing diagnostic kits and services for unmet clinical needs in China, has announced today that it has formed an alliance with the Canada-based DiagnoCure, Inc. (TSX: CUR) (OTCQX: DGCRF) to commercialize the Previstage™ GCC colorectal cancer staging test in China. 

Under the exclusive license and collaboration agreement, DiagnoCure has granted Shuwen Biotech an exclusive license to commercialize the Previstage™ GCC colorectal cancer staging test in the Greater China Region (China, Hong Kong, and Taiwan).  Shuwen Biotech will conduct clinical trials in China on an IVD kit format of the Previstage™ test, and obtain a regulatory approval from the Chinese FDA for the kit.  Shuwen Biotech will manufacture the IVD kit in its own manufacturing facilities and market the kit to major Chinese hospitals.  In addition, Shuwen Biotech will also offer the Previstage™ testing service from its own clinical reference lab. 

“Shuwen Biotech is a leading molecular diagnostic company in China led by its Chairman and CEO Jay Z. Zhang, a diagnostic industry veteran, who was formerly a senior vice president at Myriad Genetics.  Collaborating with Jay and his team will undoubtedly create value for both corporations and most importantly help colon cancer patients receive the most appropriate treatment,” commented Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure. 

“The ability to collaborate with DiagnoCure and to market Previstage™ GCC in the Greater China Region provides Shuwen with an exciting opportunity.   We strongly believe in the benefits of Previstage™ GCC to help in staging and better control of colorectal cancer, a condition afflicting unfortunately a growing number of patients in China,” said Mr. Jay Z. Zhang.

About Shuwen Biotech Co., LTD
Based in China, Shuwen Biotech is a diagnostic company providing China’s physicians and their patients with the most innovative diagnostic products and services to meet the growing need for improved prediction, prevention, diagnosis, prognosis, and treatment of diseases.  The company is engaged in licensing, developing, marketing and distributing innovative diagnostic products and services for disease diagnosis and personalized medicine. 

About DiagnoCure 
DiagnoCure (TSX: CUR; OTCQX: DGCRF) is a life sciences corporation that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Corporation launched a colorectal cancer staging test through its U.S. CLIA laboratory. Previstage^TM GCC is currently available for licensing. The Corporation has granted a worldwide exclusive license on the diagnostic applications of its proprietary molecular biomarker PCA3 to Gen-Probe, now a wholly-owned subsidiary of Hologic Inc. Hologic Gen-Probe's PROGENSA® PCA3 prostate cancer test is commercialized in Europe under CE mark and is approved for commercialization in Canada and the United States.

Contact

Jay Z. Zhang
Shuwen Biotech Co., Ltd.
info@shuwenbiotech.com

Uppsala, Sweden, June 10, 2014 / B3C newswire / -  Beactica, the Swedish fragment-based drug discovery company, today announced that it has entered into an agreement with Medivir AB (OMX: MVIR). Under the agreement, Beactica will use its proprietary discovery platform to identify novel hits against a disease-relevant protease of therapeutic interest to Medivir. Financial terms of the agreement were not disclosed.

“We are pleased that Medivir has selected Beactica to advance one of their prioritized discovery programmes”, said Beactica CEO, Dr Per Källblad. “Medivir is at a very exciting point in their development and we are looking forward to tackle this challenging project together with their team of innovative scientists”.

Dr Richard Bethell, Executive Vice President Discovery Research, Medivir commented: “We at Medivir are very much looking forward to collaborating with our partners at Beactica, and applying their fragment-based lead discovery technology, in our search for hits active against one of our early discovery targets".

About Beactica 
Beactica AB is a specialist drug discovery company, utilising its proprietary methodologies to evaluate the interactions of molecules in order to generate novel therapeutics. The Company offers expertise and services in the area of SPR biosensor-based small molecule interaction analysis and partnerships for fragment-based lead generation using its proprietary discovery platform. Founded in 2006 based on research carried out at Uppsala University and first-hand experience from the drug discovery industry, Beactica has established a robust reputation as the leader in SPR biosensor-based small molecule drug discovery. As well as providing services and building collaborations with external companies, Beactica is progressing its own drug discovery programmes.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics. 

 
Contact
Dr Per Källblad
Beactica CEO
+46 18 56 08 80

Uppsala, Sweden, June 17, 2014 / B3C newswire / – Biotage (STO: BIOT), a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, announces the launch of the new ISOLUTE® SLE+ 1 mL Supported Liquid Extraction 48-well plates, enabling the extraction of larger sample volumes (1 mL total load volume) than presently possible in the microplate footprint.

The new ISOLUTE® SLE+ 1 mL sample volume 48-well plates are packed with ISOLUTE SLE+ material; each well containing sufficient ISOLUTE® SLE+ material to efficiently extract 1 mL of aqueous sample.  Existing 96-well formats have a maximum capacity of 400 µL, the new plates enable customers to extract larger sample volumes and therefore achieve higher sensitivity, higher throughput and lower detection limits.

The new plates are ideal for the extraction of small molecule drugs, metabolites and endogenous biomarkers from biological fluid samples prior to analytical techniques such as LC-MS/MS and GC-MS. Analytical chemists in clinical, forensic toxicology and Pharmacology will appreciate the high throughput and extra sample capacity.

As with the other products in the ISOLUTE® SLE+ range, the same simple load-wait-elute procedure is used with this new 48-well format reducing method development time.

The plates can be processed using microplate compatible positive pressure manifolds, such as the Biotage® Pressure+ 96, vacuum manifolds such as the Biotage® VacMaster™ 96 and most automated liquid handling systems.

The plate is arranged in a 6 x 8 array; with 48 samples being processed per plate a higher throughput than equivalent column formats is achievable. A new compatible 48-well collection plate is also available with a 5 mL capacity so that the entire elution solvent volume can be collected with no need to swap collection vessels.

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 +81 422 28 1233, 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 290 employees with sales of 444.6 MSEK in 2013. Biotage is listed on the NASDAQ OMX Nordic Stock Exchange.

For further press information from Biotage please 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

Canterbury, UK, June 18, 2014 / B3C newswire / – Ziarco Pharma Ltd, a biopharmaceutical company focusing on steroid-unresponsive inflammation and allergic diseases, is pleased to announce this prestigious award of grant funding from the TSB.

The award will be used by Ziarco to further develop ZPL-389, a novel, oral antagonist of the recently-discovered histamine H4 receptor which is in clinical development to treat a number of dermatological, and potentially other inflammatory diseases. Specifically, the funding will be used to support a Phase 2a clinical study to further evaluate the safety and efficacy of ZPL-389 in patients with Atopic Dermatitis.

Atopic Dermatitis (AD) is a poorly treated inflammatory dermatological disorder. It affects all ages, from young infants through to the elderly. The condition including the itching (chronic pruritus) can result in disturbed or otherwise poor sleep, mood changes and a general increase in other illnesses for sufferers.  Although some older treatments exist, there is a significant need for new therapies, especially oral treatments that are safe for long term use and address all features of the disease, including itch. ZPL-389 has already been studied in over 60 subjects in two different countries.

Ziarco believes that ZPL-389 is one of only two clinical-stage oral H4 antagonists in active development. Previously, ZPL-389 has completed a 14 day multi-dose study as well as earlier Phase I studies incorporating a dose-setting biomarker. With the recent completion of additional subchronic non-clinical toxicology work, ZPL-389 is ready for patient studies which are the subject of the TSB grant.

Dr Mike Yeadon, CEO of Ziarco, said: “We are pleased to have won this valuable award and we are grateful to the Technology Strategy Board for their diligence. We believe that H4 antagonism will prove a valuable new contribution to treatment of many diseases and that ZPL-389 will make a real difference to patients suffering from itch and skin inflammation. The Biomedical Catalyst funding is a big help in enabling us to conduct the upcoming AD study, and thus to take an additional step in bringing ZPL389 to patients. If successful, ZPL-389 may have the chance to treat millions of patients worldwide, from the young through to the elderly”.

About Ziarco
Ziarco is a clinical-stage biotechnology company developing innovative therapeutics targeting inflammatory and allergic diseases. The company’s product pipeline includes a histamine H4 receptor antagonist programme with potential in multiple therapeutic areas, including a number of inflammatory skin diseases as well as rheumatoid arthritis, psoriatic arthritis, asthma and pain. A lead H4 antagonist has completed a Phase 1 multiple ascending dose study.  A second clinical-stage programme targets inflammatory disorders by inhibiting cytosolic phospholipase A2 (cPLA2). The pipeline is completed by a histamine H3 receptor antagonist programme possessing CNS-sparing properties which is in advanced preclinical development and an early-stage spleen tyrosine kinase (SYK) inhibitor programme suitable for topical administration. Investors in Ziarco include Biotechnology Value Fund L.P. and other affiliates of BVF Partners L.P. and Pfizer Venture Investments.

About Technology Strategy Board
The Technology Strategy Board is the UK’s innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy.

About Catalysts
Catalysts are run jointly by the Technology Strategy Board and the Research Councils. A Catalyst is a form of research and development funding which focuses on a specific priority area and aims to help take projects from research to as close to commercial viability as possible. The Catalyst model supports projects in priority areas where the UK research base has a leading position and where there is clear commercial potential. Current Catalysts include: Biomedical Catalyst, Agri-tech Catalyst and the Industrial Biotechnology Catalyst.

 
Contact
Mike Yeadon
+44-1227-459119
mike.yeadon@ziarcopharma.com

Berlin, Germany, June 18, 2014 / B3C newswire / - BioGenes GmbH, a leader in host cell protein (HCP) assay development for biomanufacturing processes, announce the availability of a 2-D DIGE Western Blot service for highly accurate determination and electronic quantification of HCP coverage.

2-D DIGE Western Blot is a DIGE based fluorescent two-dimensional gel electrophoresis combined with a Western Blot that detects whole protein and HCP antibody signals on the same membrane. It allows the protein spots to be aligned perfectly with immuno-detected spots, thus eliminating any gel-to-membrane variations. 2-D DIGE Western Blot uses two CyDye fluorescent dyes for labelling of total protein and HCP antibodies which enable signal detection at different wavelengths. CyDye fluorescence labelling is very sensitive and produces sharp and clear spots allowing an accurate and fully electronic analysis.

HCPs comprise the majority of protein contaminants derived from the manufacturing of therapeutic proteins and vaccines. HCPs are often immunogenic, can alter the therapeutic efficacy of a therapeutic drug substance and may affect patient safety. Therefore, the detection and quantification of HCPs is a major precondition for clinical trials of therapeutic proteins in human beings.

ELISA is a widely used technique to measure the residual HCPs and assess product purity. The current technique for estimating coverage of the HCP antibodies to the total HCPs present in a cell line is the comparison of a Coomassie Blue stained 2-D gel electrophoresis with an immunologically stained 2-D Western Blot. However, this technique may produce errors in pattern alignment between gel and membrane, is less sensitive than fluorescence and the results cannot be evaluated electronically.

About BioGenes GmbH
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

GLASGOW, Scotland, UK, June 19, 2014 / B3C newswire / – BioOutsource Ltd. (“BioOutsource”), a leading international Contract Testing Organisation (CTO) today announced their partnership with PsiOxus Therapeutics Ltd. to support clinical sample analysis of their Phase I/II OCTAVE (Ovarian Cancer) study.

PsiOxus Therapeutics, Ltd., an Oxford, based biotechnology company, has been awarded a £1.7 million grant towards a Phase I/II clinical trial to assess the use of Enadenotucirev (previously known as ColoAd1) in the treatment of platinum-resistant, recurrent ovarian cancer. The funding is from the UK government-backed Biomedical Catalyst, a programme run jointly by the Technology Strategy Board and the Medical Research Council. The OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) study will be the second clinical trial of the oncolytic vaccine Enadenotucirev, a highly potent, broad-spectrum, anticancer therapeutic capable of destroying tumour cells at very low concentrations.

The OCTAVE Phase I/II study will assess the safety and efficacy of Enadenotucirev when given to patients by intra-peritoneal perfusion at multiple UK cancer centres beginning in June 2014.  The Principal Investigator of the OCTAVE study will be Professor Iain McNeish from the Institute of Cancer Sciences at the University of Glasgow. Clinical sample analysis will take place at BioOutsource Ltd, Glasgow, based in the West of Scotland Science Park.

BioOutsource CEO Gerry Mackay commented “BioOutsource are delighted to collaborate with such an innovative biotechnology company as Psioxus Therapeutics and we look forward to continuing to provide ongoing analytical support to assess the efficacy of Enadenotucirev in clinical trials.” 

 
About BioOutsource Ltd
BioOutsource provides contract testing services to the biopharmaceutical industry. Our core offering includes a comprehensive range of services to support the testing of Biologics, Vaccines & BioSimilars throughout their development. We possess an unparalleled combination of commercial, regulatory and technical knowledge that enables us to truly stand out as the industry’s increasingly preferred testing partner. We understand the importance of our service to support our client’s critical testing requirements and as a result, continually strive to provide a world class service globally. 

Contacts

Gemma Fulton
Sales & Marketing Department
BioOutsource, Ltd.
+ 44 (0) 141 946 4222
gfulton@biooutsource.com

Laupheim, Germany, June 20, 2014 / B3C newswire / – Rentschler Biotechnologie GmbH, a leading contract manufacturing organization (CMO) for the development and production of biopharmaceuticals, announces the investment of €24m to build a Twin system with two 3,000 L stainless steel bioreactors mainly targeting market supply at the company’s site in Laupheim, Germany. The Twin system should be operational in early 2017.

The Twin system is designed for running two main bioreactors in parallel with one shared downstream processing unit thus providing higher throughput while reducing incremental labor costs involved. It integrates well into the existing 3,000 L GMP line and will more than double the production capacities for cell culture-derived proteins. The Twin system allows us to run cell culture processes in fed-batch mode with a very high output in a single suite.

“The expansion will strengthen our global competitiveness and increase our market awareness of being a CMO partner of first choice all the way down from early clinical trials up to approval and market supply with a wide range of manufacturing technologies to offer” explains Frank Ternes, Chief Business Officer at Rentschler.

In the last few years, Rentschler has been heavily investing in single-use technology and only recently announced that it will add a new 2,000 L single-use bioreactor. Nevertheless, manufacturing in stainless steel is far from being outdated. Rentschler is experiencing a high demand for stainless steel bioreactor capacity, mainly for market supply, but also for late clinical phases. The criteria for bioreactor selection includes the characteristics of the product to be manufactured, the approval phase, the expected volume requirements, the required flexibility, and competitive pricing due to optimal technological fit.

 
About Rentschler
Rentschler is a CMO with over 35 years proven track record in biopharmaceuticals. Focused on the utilization of mammalian cell lines, Rentschler’s long history covers the development and production of recombinant proteins in compliance with international GMP standards. Rentschler’s customized solutions range from supporting drug candidate selection, cell line and process development capabilities as well as GMP production to comprehensive analytics and fill & finish. Rentschler’s state-of-the-art manufacturing facility includes bioreactors up to 3,000 L and aseptic filling lines for vials (including lyophilization) and prefilled syringes. Our long-term experience with international regulatory affairs and authorities complements the offerings. Rentschler’s full-service concept allows flexibility on the individual project requirements.

Contact

Dr. Marion Schrader
Senior Director Marketing
Rentschler Biotechnologie GmbH
Tel.: +49 (0) 7392 701 0
Marion.Schrader@rentschler.de