BioVaxys Technology Corp, a biotechnology company, announced the signing of a definitive exclusive bioproduction agreement (the Agreement) with BioElpida SAS (BioElpida), a CDMO organization based in Lyon (France), to initiate the clinical grade bioproduction and aseptic packaging of BXV-0918A, BioVaxys' vaccine candidate for stage III and IV ovarian cancer.
BioVaxys and BioElpida signed a terms sheet in February outlining the terms of the business relationship. The final agreement reached today mainly concerns the construction of a facility certified to good manufacturing practices (GMP) in Lyon, as well as technical aspects of the bioproduction protocol, such as process design and validation, quality control and assurance steps, batch testing, stability testing and aseptic filling. BioVaxys expects to be able to prepare a regulatory request by the end of the year to conduct a phase I study in the EU on the use of BVX-0918A in stage III and IV ovarian cancer. The vaccine batch for the planned clinical study is expected to be ready in early May 2022.
“We decided early on to seek out a bioproduction partner capable of rapidly moving from manufacturing small batches of GMP grade supplies for clinical studies to large-scale manufacturing in the event that our clinical trials prove successful and where the EU grants us the required regulatory approval, said Kenneth Kovan, co-founder, president and COO of BioVaxys. BioElpida's technical experience and its previous work on the first generations of our cancer vaccine platform will be valuable assets in supporting our efforts to bring hope to people with ovarian cancer advanced stage. "
BioVaxys is currently collaborating with Spanish biopharmaceutical company ProCare Health Iberia SAS on the ovarian cancer vaccine clinical program. The Spanish company plans to submit a clinical trial request (CTA) to the European Medicines Agency (EMEA) later this year to authorize the compassionate use of BVX-0918A in the context of stage III and IV ovarian cancer. ProCare Health will have the rights to market BVX-0918A in the EU and UK, while BioVaxys will market its ovarian cancer vaccine in North America and the rest of the world.
Globally, more than 300,000 women are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer being the leading cause of death from gynecologic malignancies in the United States (American Cancer Society Data and Statistics 2020). There are an estimated 21,750 new cases of ovarian cancer in the United States in 2020 andto 13,940 the number of deaths (National Cancer Institute in the United States, Surveillance and Epidemiology Program in the United States, 2020).
The majority of women with stage III or IV cancer will eventually have recurrent disease that is resistant to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have a limited life expectancy, even with multiple lifesaving treatments. This large group of non-responders or patients who relapse after first-line treatment is the initial target market for BioVaxys.