BioVaxys Technology (BIOV) has signed the definitive exclusive bioproduction agreement with BioElpida S.A.S. (BioElpida) of Lyon, France.
The companies will begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys’ vaccine candidate for Stage III/Stage IV ovarian cancer.
The definitive agreement focuses 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 submit its regulatory submission for an 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 in early May 2022.
BioElpida is a biotechnology contract development and manufacturing company that applies single-use bioprocessing for the 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 S.A.S., 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. BioVaxys will market BVX-0918A in North America and the rest of the world.
Worldwide, over 300,000 women are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer the leading cause of death from gynecologic malignancy in the United States. An estimated 21,750 new cases of ovarian cancer were expected in the US in 2020 with 13,940 deaths. The majority of women with Stage III or Stage IV cancer will ultimately have recurrent disease resistant to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have limited life expectancy even with multiple salvage regimens.
Non-responders to first-line therapy, or those who relapse after first-line therapy, are the initial target market for BioVaxys.
The global ovarian cancer drugs market was valued US$1.2B in 2017 and is expected to reach US$4.6B by 2026.
BioVaxys Technology Corp. is a clinical-stage immunotherapeutics company developing vaccine platforms for SARS-CoV-2 and various cancers.
BioVaxys Technology (BIOV) is up 2.86 per cent, trading at C$0.36 per share at 2:30 pm ET.