BioVaxys Technology Corp. announced the successful sterile and bacteria-free test-run production of BVX-0918, the Company's bi-haptenized autologous ovarian cancer vaccine. 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 50% 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.