Date: 2014-09-11
Type of information: Clinical research agreement
Compound: AST-VAC2
Company: Cancer Research UK (UK) Cancer Research Technology (UK) Asterias Biotherapeutics (USA -CA)
Therapeutic area: Cancer - Oncology - Regenerative Medicine
Type agreement:
Action mechanism: AST-VAC2 is an immunotherapeutic product candidate consisting of human embryonic stem cell derived- mature dendritic cells (hESC-DCs) that are engineered to express telomerase. AST-VAC2 is designed as an “off-the-shelf” vaccine platform to stimulate an immune response against tumor cells expressing telomerase. Telomerase is expressed in most human cancers, and plays an important role in the prolonged proliferative lifespan of cancer cells. In contrast, telomerase expression is rare and transient in most normal adult tissues, making telomerase an attractive target for cancer immunotherapy. Previous studies of a patient specific (autologous), peripheral blood-derived, dendritic cell vaccine targeting telomerase (AST-VAC1) in prostate cancer and acute myelogenous leukemia (AML) provided promising data supporting the safety and feasibility of dendritic cell-based telomerase immunotherapy, and showed telomerase-specific immune responses in 55% of AML and 95% of prostate cancer patients.
Disease: non-small cell lung cancer.
Details: * On September 11, 2014, CANCER RESEARCH UK and Cancer Research Technology (CRT), the charity\'s development and commercialisation arm, have reached an agreement with Asterias Biotherapeutics, a biotechnology company in the emerging field of regenerative medicine, to take forward Asterias\' novel immunotherapy treatment AST-VAC2 into clinical trials in subjects with non-small cell lung cancer. AST-VAC2 is a non-patient specific (allogeneic) cancer vaccine designed to stimulate patients\' immune systems to attack telomerase. The vaccine was developed following successful early phase clinical trials of a similar, patient specific (autologous) Asterias vaccine, called AST-VAC1, which was derived from patients\' blood cells and tested in prostate cancer and acute myeloid leukemia. Unlike AST-VAC1, and other autologous (patient specific) vaccines that are developed from a patient\'s own cells, AST-VAC2 is derived from human embryonic stem cells (hESCs), meaning it can be produced on a large scale and stored ready for use, rather than having to produce a specific version of the drug for each patient. The trial of AST-VAC2 will evaluate the safety and toxicity of the vaccine, feasibility, stimulation of patient immune responses to telomerase and AST-VAC2, and clinical outcome after AST-VAC2 administration in patients with resected early-stage lung cancer and in patients with advanced forms of the disease. Under the agreement, Asterias will complete development of the manufacturing process for AST-VAC2. Cancer Research UK will then produce the vaccine and conduct the phase 1/2 clinical trial in the UK. On completion of the clinical trial, Asterias will have an exclusive first option to acquire a license to the data from the trial on pre-agreed terms including an upfront payment, milestones and royalties on sales of products. If Asterias declines this option, CRT will then have an option to obtain a license to Asterias\' intellectual property to continue the development and commercialisation of AST-VAC2 and related products in exchange for a revenue share to Asterias of development and partnering proceeds. AST-VAC2 represents the tenth treatment to enter Cancer Research UK\'s Clinical Development Partnerships* (CDP) scheme, with six having progressed into the clinic to date. CDP is a joint initiative between Cancer Research UK\'s Drug Development Office (DDO) and Cancer Research Technology, to develop promising anti-cancer agents which pharmaceutical companies do not have the resources to progress through early phase clinical trials.
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