Ovarian Cancer Vaccine Candidate Completes Successful Bi-Haptenized Test-Run

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

The process of haptenization teaches a patient's immune system to recognize and make target proteins more 'visible' as foreign, thereby stimulating a more intense immune response.

Single haptenization only modifies hydrophilic amino acids on antigenic proteins, but utilizing two different haptens modifies both hydrophilic and hydrophobic amino acids on these target proteins, making the protein more foreign to the immune system with modification of additional amino acids. 

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.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated in a press release on December 1, 2022, "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."

"Our EU clinical development and marketing partner, Procare Health Iberia, has selected a CRO and has already begun meeting with prospective Spanish Phase I study investigators."

The CTA is the European equivalent of the U.S. FDA's Investigational New Drug application, which is filed to seek approval for a clinical study.

Based in Vancouver, BioVaxys Technology is a clinical-stage biotechnology company developing viral and oncology vaccine platforms and immuno-diagnostics.