お知らせ • Jan 23
Biovaxys Reports Positive Clinical Study Results from Phase 1B/2 Pesco Trial of Mvp-S with Pembrolizumab (Keytruda) and Low-Dose Cyclophosphamide for Patients with Recurrent Epithelial Ovarian Cancer
BioVaxys Technology Corp. announced positive preliminary results from the PESCO study, an investigator-initiated, open-label, non-randomized phase 1B/2 trial to evaluate the safety and efficacy of combination of BioVaxys' MVP-S with pembrolizumab (Keytruda™?) and cyclophosphamide in patients with recurrent epithelial ovarian cancer (EOC). Led by Principal Investigator Amit Oza, MD, Director of the Cancer Clinical Research Unit, Princess Margaret Cancer Centre, University of Toronto and Chair, UHN Clinical Research Collaborative Centre, the primary study objectives were safety, recommended phase 2 dose, and clinical efficacy based on disease control rate (DCR) and overall response rate (ORR). Secondary objectives included efficacy in patients with platinum sensitive (Cohort A) and platinum resistant disease (Cohort B), progression free survival (PFS) and overall survival (OS). New advances, such as immune checkpoint inhibitor monotherapy, have demonstrated only limited efficacy in treating ovarian cancer. A phase 3 clinical study of the immune checkpoint inhibitor nivolumab reported a lower ORR of 8% compared to an ORR of 13% with the chemotherapeutics gemcitabine or doxorubicin, without improving OS and with worse progression-free survival in patients with recurrent epit epithelial ovarian cancer.1 Recent studies with checkpoint inhibitors, such as anti PD-1, with immunotherapeutic cancer vaccines demonstrates the potential to expand antigen-specific T-cells and inhibit regulatory T-cells (Tregs), thereby enhancing the overall tumor immune response2. Additional studies have shown a synergistic effect between checkpoint inhibitors and cancer vaccines, thus positioning these combinations for further exploration, with the optimization of these combinations reliant on selection of the ideal cancer vaccine antigens.3. survivin, a tumor-associated antigen, is highly expressed in ovarian and other cancers but nearly undetectable in normal tissues, making it a promising target for ovarian cancer immunotherapy. Other studies suggest that anti-PD1 enhances the robust antigen-specific, cytotoxic immune response already induced by MVP-S. These findings reinforce survivin as a viable target for immunotherapy in ovarian cancer, together with checkpoint inhibitors such as anti PD-1." The BioVaxys DPX platform is a major innovation in vaccine development that offers a solution to limitations faced by vaccines using other antigen delivery methods. The DPX platform presents antigens to the immune system using a novel non-systemic mechanism of action that does not release active ingredients at the site of the injection, but rather forces an active uptake of immune cells and delivery into the lymphatic nodes. The programming of immune cells happens in vivo and offers a more efficient approach that mimics the natural function of the immune system. This "no release" mechanism allows for an active uptake of antigens into immune cells and lymph nodes for a sustained activation of the immune system in which the T cell flow is sustained over a longer duration than traditional vaccines on the market. The Company's clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX platform, in phase IIB clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its DPX platform can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications.