BioVaxys announced successful trial production of disemiptenated vaccines

BioVaxys Technologies (CSE: BIOV) (FRA:5LB) (OTCQB:BVAXF) (hereinafter referred to as "BioVaxys" or the "Company") is pleased to announce that the Company's disemipten autologous ovarian cancer vaccine BVX-0918 has successfully completed sterilization and sterile pilot manufacturing
.

The complete manufacturing of BVX-0918 from an ovarian tumor in a cancer patient validates manufacturing practices developed over the past few months, including for successful extraction of tumor cells, cryopackaging and cryopreservation of tumor cells, identification of ovarian cancer cells as a component using specially developed monoclonal antibodies and flow cytometry, sterilization process, and development of a double semiptenation process
for ovarian tumor cells for epidemic seedlings.

These manufacturing specifications establish semi-automatic technology for the mechanical extraction of tumor cells from tumor blocks, reducing the time required for tumor cell haptenization by 50%, thus saving time in GMP production
.

Next steps include further optimizing the seedling production process, finalizing the GMP manufacturing specifications for BVX-0918, then transferring the manufacturing specifications to larger scale production, and conducting GMP verification for submission to the EU regulator for CTA
.
CTAs in Europe are equivalent to FDA's investigational new drug application (IND) and are submitted for clinical study approval
.

Kenneth Kovan, President and Chief Operating Officer of BioVaxys, said, "BioVaxys has successfully reached an important manufacturing milestone
by establishing a process for surgical removal of ovarian cancer cells from cancer patients, binding two haptens, and producing sterilized and sterile intact seedlings.
The next work included GMP product characterization and the application of analytical methods to verify that each step of BVX-0918 production was performed
under GMP conditions that met the requirements 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 begun meeting
with researchers from potential Spanish Phase I studies.
"