The two companies have signed the new definitive agreement focusing on the GMP facility build-out in Lyon, and technical aspects of the bioproduction protocol such as process design and validation, quality control and quality assurance steps, batch test runs, stability testing, and aseptic fill
Ovarian cancer is represented by teal cancer ribbon colors
BioVaxys Technology has signed the definitive exclusive bioproduction agreement with France-based BioElpida to begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys' vaccine candidate for Stage III/Stage IV ovarian cancer.
The two companies executed a term sheet in February outlining the commercial relationship, with the new definitive agreement focusing on the GMP facility build-out in Lyon, and technical aspects of the bioproduction protocol such as process design and validation, quality control and quality assurance steps, batch test runs, stability testing, and aseptic fill.
BioVaxys expects to be able to prepare its regulatory submission for a EU Phase I study of BVX-0918A in Stage III/Stage IV ovarian cancer near the end of this year, with vaccine supply for the planned clinical study available early May 2022.
BioElpida is a biotechnology CDMO, which applies single-use bioprocessing for development and manufacturing of biological and cell-based products. BioElpida's expertise extends from R&D to pharmaceutical manufacturing and release of clinical batches, and intermediate steps such as process development, feasibility studies, analytical method validation, as well as aseptic fill & finish and other bioproduction services. BioElpida's facility is certified for clinical bioproduction by France's National Security Agency of Medicines and Health Products (ANSM).
"Early on we made the decision to seek a bioproduction partner with the ability to quickly move from smaller-yield GMP-grade clinical study supplies to large-scale manufacturing if our clinical trials prove successful and EU regulatory approval is granted," said Kenneth Kovan, Co-Founder, President and Chief Operating Officer of BioVaxys. "BioElpida's technical experience and previous work on early generations of our cancer vaccine platform will be a significant advantage in our efforts to provide hope to those suffering from advanced ovarian cancer."
BioVaxys is collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia, which plans to submit a Clinical Trial Application (CTA) for BVX-0918A to the European Medicines Agency (EMEA) later this year for a compassionate use approval in Stage III & Stage IV ovarian cancer. ProCare Health will have marketing rights to BVX-0918A in the EU and UK, whereas BioVaxys will market its ovarian cancer vaccine in North America and Rest of World.