Asterias Biotherapeutics Announces Completion of Transfer of AST-VAC2 Manufacturing Process to Cancer Research UK as Milestone Towards Initiating Phase 1/2 Clinical Trial

Jan 21, 2016, 07:00 ET from Asterias Biotherapeutics, Inc.

FREMONT, Calif., Jan. 21, 2016 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), announced that it has completed the transfer of its manufacturing processes to produce AST-VAC2 to Cancer Research UK.

AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) AST-VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase permits enhanced stimulation of immune responses to the protein. The AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase which will target tumor cells.

To accelerate clinical development of AST-VAC2, Asterias has an ongoing partnership with Cancer Research UK and Cancer Research Technology, the charity's development and commercialization arm, to execute the first clinical trial of AST-VAC2. As part of this partnership, Cancer Research UK will perform cGMP manufacture of AST-VAC2 at their Biotherapeutics Development Unit. In preparation for cGMP production, Asterias developed the production process for AST-VAC2 to support the transfer and further scale-up in Cancer Research UK's manufacturing facility for the Phase 1/2 clinical study. To that end, Asterias has completed transfer of the AST-VAC2 manufacturing process information to Cancer Research UK. Cancer Research UK is now verifying and scaling up the production of AST-VAC2 in their facility in preparation for pilot and full cGMP campaigns. Upon successful completion of AST-VAC2 production campaigns, Cancer Research UK's Centre for Drug Development ("CDD") will  submit a Clinical Trial Authorisation application to the  UK regulatory authorities for a Phase 1/2 clinical trial in non-small cell lung cancer, which will be sponsored, managed and funded by CDD. The clinical trial will examine the safety, immunogenicity and activity of AST-VAC2 and position the immunotherapy to be tested for numerous clinical indications.

"Transfer of the manufacturing process for AST-VAC2 marks an important milestone in our partnership with Cancer Research UK and is a critical step towards initiating the first clinical trial of AST-VAC2," said Pedro Lichtinger, Chief Executive Officer of Asterias. "The program with Cancer Research UK will assess the safety and activity of AST-VAC2 and serve as a foundation for further clinical development in lung and other cancers."

"The design of AST-VAC2 affords three unique properties to this dendritic cell immunotherapy," stated Jane S. Lebkowski, Ph.D., President of R&D and Chief Scientific Officer of Asterias. "Being produced from pluripotent stem cells, AST-VAC2 can be manufactured at batch-scale and be available on-demand for patient use.  Second, the telomerase protein in AST-VAC2 is specifically engineered to target the two major pathways stimulating T cell immune responses, inducing more robust and durable cellular immune responses to telomerase. Lastly, the non-patient specific, allogeneic, nature of AST-VAC2 could potentially provide signals to further amplify immune responses."

"Based on its mode of action, AST-VAC2 is likely to be synergistic with immune checkpoint inhibitors and other adoptive immunotherapies that are being used for treatment now," stated Katy Spink Ph.D., Chief Operating Officer of Asterias. "The combination of the immunostimulatory activity of AST-VAC2 with the drugs that downregulate inhibitors of immune responses could provide a very powerful tool for the treatment of multiple cancers."

Dr. Nigel Blackburn, Cancer Research UK's director of drug development, said: "This drug could potentially treat most tumour types as it targets the telomerase protein – which is faulty in 95 per cent of all cancers. The treatment's design means it could also boost the effects of other immunotherapies and be used in combination.

"Lung cancer is the biggest cancer killer so we desperately need to find new treatments for the disease. And we're pleased to be working with Asterias Biotherapeutics to develop this new treatment and to test it in clinical trials for non-small cell lung cancer for the first time."

About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. (NYSE MKT: AST) is a leading biotechnology company in the emerging field of regenerative medicine. The Company's proprietary, industry leading platforms are based on its pluripotent stem cell and dendritic cell immunotherapy technologies. Asterias is focused on developing therapies to treat conditions in several medical areas where there is high unmet medical need and inadequate available therapies. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) has demonstrated promise in a Phase 2 study in acute myelogenous leukemia. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic approach to dendritic cell vaccines. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

About Cancer Research UK

  • Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research.
  • Cancer Research UK's pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
  • Cancer Research UK receives no government funding for its life-saving research. Every step it makes towards beating cancer relies on every pound donated.
  • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last forty years.
  • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK's ambition is to accelerate progress so that 3 in 4 people will survive their cancer for at least 10 years within the next 20 years.
  • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
  • Together with its partners and supporters, Cancer Research UK's vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

About Cancer Research UK's Centre for Drug Development
Cancer Research UK has an impressive record of developing novel treatments for cancer. It currently has a portfolio of around 30 new anti-cancer agents in preclinical development, phase I or early phase II clinical trials. Having supported drug development since the 1980s, the Cancer Research UK Centre for Drug Development, formerly the Drug Development Office was established in 1992. It has taken over 120 potential new anti-cancer agents into clinical trials in patients, five of which have made it to market and many others are still in development. These include temozolomide, a drug discovered by Cancer Research UK scientists, that is an effective treatment for brain cancer and abiraterone, which is used to treat prostate cancer. This rate of success is comparable to that of any pharmaceutical company.

About Cancer Research Technology
Cancer Research Technology (CRT) is a specialist commercialisation and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is a wholly owned subsidiary of Cancer Research UK, the world's leading cancer charity dedicated to saving lives through research. Further information about CRT can be found at www.cancertechnology.com and about Cancer Research UK at www.cancerresearchuk.org.

FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias's filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

 

SOURCE Asterias Biotherapeutics, Inc.



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