Asterias Biotherapeutics, a Fremont, California-based biotechnology company focused on regenerative medicine, has selected Cognate BioServices, a Hanover, Maryland-based third-party provider of process development and cGMP manufacturing services, to perform process development studies for the clinical and commercial development of Asterias Biotherapeutics' patient-specific cancer vaccine, AST-VAC1.

Cognate BioServices will also manufacture AST-VAC1 under cGMP. In parallel with ongoing process development efforts, Asterias Biotherapeutics is currently developing plans for further progressing the AST-VAC1 clinical program.

The company is developing AST-VAC1 for treating acute myeloid leukemia. In February 2016, the company announced a positive meeting with the US Food and Drug Administration (FDA) to validate its Phase III clinical strategy. The FDA will consider AST-VAC1 for accelerated approval, according to Asterias Biotherapeutics.

Source: Asterias Biotherapeutics