AST-VAC2 is an allogeneic (non-patient specific) cancer vaccine designed to stimulate patient immune responses to telomerase, which is expressed in over 95% of human cancers but is rarely expressed in normal adult cells.

This treatment represents a second generation approach to the same telomerase loaded, dendritic cell vaccination immunotherapy strategy that has been tested in two previous clinical trials of our AST-VAC1 product.

The use of human embryonic stem cells, as opposed to patient blood, as the starting material for AST-VAC2 provides a scalable system for the production of a large number of vaccine doses in a single lot, reducing manufacturing costs, enabling “off-the-shelf” availability, and ensuring product consistency. Additionally, this approach has the potential to stimulate a more robust immune response through an adjuvant effect of the immune mismatch between AST-VAC2 and patients. Due to its mechanism of action, we anticipate that AST-VAC2 will be synergistic with immune checkpoint inhibitors currently in development for many cancer indications.

Our current efforts in the AST-VAC2 program are focused on progressing this product towards a Phase 1/2a clinical trial in non-small cell lung cancer in collaboration with Cancer Research UK (CRUK). Under the collaboration, CRUK will conduct the Phase 1/2a trial, providing the resulting data to Asterias through a license agreement. The CRUK collaboration provides the AST-VAC2 program with external scientific validation, access to CRUK’s tremendous network in oncology, and allows Asterias to advance this program into clinical development at minimal cost to our shareholders.

To enable scaling long term, we have entered into an agreement with Cell Therapy Catapult Services, a research organization specializing in the development of technologies which speed the growth of the cell and gene therapy industry. Cell Therapy Catapult will develop a scalable manufacturing and differentiation process for AST-VAC2 in order to support the downstream demands of clinical trials and ultimately commercialization.

AST-VAC2 is scalable and “off-the-shelf”

Although we are focused on development in lung cancer at present, AST-VAC2 has potential for broad applications in oncology because telomerase is expressed in more than 95% of cancers. Additionally, the allogeneic platform has the flexibility to leverage alternative antigens beyond telomerase, which could extend AST-VAC2 applications even further.