Cognate to make dendritic cell cancer vaccine in $2.2m deal with Asterias

By Dan Stanton contact

- Last updated on GMT

Image: iStock/arinarici
Image: iStock/arinarici

Related tags: Stem cell, Immune system

Asterias Biotherapeutics has selected Cognate BioServices for the process development and manufacture of its autologous dendritic cell vaccine candidate, AST-VAC1.

The Fremont, California-based biotech firm has three products in clinical development, its most advanced being AST-VAC1, an autologous (patient-specific) immunotherapy that enables a patient’s own dendritic cells to stimulate an immune response to telomerase, an antigen expressed by the majority of cancers.

Asterias is looking to initiate Phase III clinical trials for the vaccine in patients with Acute Myeloid Leukemia (AML), and announced in an SEC filing it has entered into a service agreement with Cognate BioServices which will provide clinical and commercial manufacturing services for AST-VAC1.

The deal is set to expire in August 2019 and Asterias will pay the contract manufacturing organisation (CMO) aggregate payments of up to approximately $2.2m (€2m) for the development stage.

Cognate’s cGMP facility is located in Memphis, Tennessee and boasts of the possibility of nearly 24 hour shipping due to its proximity to major UPS and FedEx hubs – something critical when dealing with the production of cell therapy products​ with short shelf lives.

Pipeline and manufacturing

The candidate is made using Asterias’s proprietary engineered cell platform which derives dendritic cells from a patient’s own white blood which are then transfected with mRNA encoding telomerase reverse transcriptase (hTERT) and the lysosomal targeting signal LAMP(4,5), before being cultured and cryopreserved.

The firm has a second vaccine in development for non-small cell lung cancer (NSCLC), AST-VAC2, which uses the dendritic cell platform but is allogeneic (non-patient specific).

Asterias’s partner Cancer Research UK (CRUK) is fully funding an upcoming Phase I/II trial and will be in charge of the manufacturing process.

The third product is AST-OPC1, oligodendrocyte progenitor cells manufactured from Asterias’s pluripotent embryonic stem cell platform, being developed for treating spinal cord injuries.

The company is looking to manufacture this product in-house, and according to a conference call this week discussing Q2 2016, has recently hit a milestone at its own facility, initiating the first commissioning runs in preparation for the eventual manufacture of AST-OPC1 master and working cell banks and clinical trial material.

“These runs will continue until the end of month and our key component to the ongoing work being done to initiative GMP manufacturing of our products at the facility,”​ said Astorias EVP of finance Ryan Chavez on the call.

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