The complete manufacturing of BVX-0918 from a cancer patient's ovarian tumor now validates the production protocols that had been in development over the past few months for the successful extraction of tumor cells, the cryo-packaging and cryo-preservation of tumor cells, identification of ovarian cancer cells as the components of the vaccine using specially developed monoclonal antibodies and flow cytometry, sterility processes, and development of the process for double haptenization of the ovarian tumor cells used in the vaccine. 

The production protocols have reduced the time needed to haptenize the tumor cells by fifty percent having established a semi-automatic technique for mechanically extracting tumor cells from a tumor mass, resulting in a time savings for GMP manufacturing.

The next steps include further optimization of the vaccine production process, finalizing the protocol for GMP manufacturing of BVX-0918, followed by transfer of the production protocol to larger scale manufacturing and GMP validation for submission of a CTA to EU regulatory authorities. The CTA is the European equivalent of the FDA's Investigational New Drug application, or IND, which is filed to seek approval for a clinical study.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated, "BioVaxys has successfully met a major manufacturing milestone by establishing the process to take surgically excise ovarian cancer cells from a cancer patient, conjugate two haptens, and manufacture a sterile and bacteria-free complete vaccine. The next steps now involve GMP product characterization and applying analytical methods to validate that each step of BVX-0918 production is under GMP conditions to the satisfaction of EU regulatory authorities. We have completed the clinical study protocol, and our EU clinical development and marketing partner, Procare Health Iberia, has selected a CRO and already begun meeting with prospective Spanish Phase I study investigators."