BioVaxys Technology signed a term sheet with BioElpida to collaborate on the build-out for the clinical-grade manufacturing process and aseptic packaging for BXV-0918A, BioVaxys’ vaccine for Stage III/Stage IV ovarian cancer. Completion of the GMP-grade bioproduction process development is planned for later this year, with the EU Phase I/II clinical trial slated for early 2022, pending European Medicines Agency (EMEA) approval.
BioElpida, a Lyon, France-based CDMO which applies single-use bioprocessing for development and manufacturing of biological and cell-based products, is working with BioVaxys towards the execution of a definitive agreement by the end of next month.
“In addition to its bioproduction expertise, the BioElpida team is intimately familiar with our haptenized protein approach, having previously been involved in the process development for the clinical supply of the ‘first generation’ haptenized tumor cell vaccines,” said Kenneth Kovan, president and COO, BioVaxys.
BioVaxys recently announced that it is collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia, which plans to submit a Clinical Trial Application for BVX-0918A to the 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.