SIGNIFICANT ADVANCEMENT TOWARDS LAUNCH OF PHASE I OVARIAN CANCER VACCINE TRIAL
VANCOUVER, BC, Feb. 18, 2021 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: LMNGF) ("BioVaxys" or "Company") announced today that it has signed a Term Sheet ("Term Sheet") with BioElpida S.A.S. ("BioElpida") of Lyon, France, 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 is a biotechnology contract development and manufacturing company ("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).
The two companies are working towards the execution of a definitive agreement by the end of this March. 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.
Kenneth Kovan, President and Chief Operating Officer of BioVaxys, stated that, "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."
BioVaxys recently announced that it 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, whereas BioVaxys will market its ovarian cancer vaccine in North America and Rest of World.
Globally, there remain significant unmet therapeutic needs for ovarian cancer treatment. 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 (American Cancer Society Facts & Figures 2020). An estimated 21,750 new cases of ovarian cancer were expected in the US in 2020 with 13,940 deaths (National Cancer Institute, Surveillance and Epidemiology Program, 2020). 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. This large group of non-responders to, or those who relapse after, first line therapy are the initial target market for BioVaxys.
