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Reports Positive Clinical Study Results from Phase 1B/2 PESCO Trial of MVP-S with Pembrolizumab (Keytruda (TM)) and Low-Dose Cyclophosphamide for Patients with Recurrent Epithelial Ovarian Cancer (EOC)
* **Study subject Remains in Complete Response for 3 Years**
* **Exceeds Expectations in Platinum-Resistant Ovarian Cancer Compared to Standard of Care Single-Agent Chemotherapy**
Vancouver, British Columbia--(Newsfile Corp. - January 20, 2026) - BioVaxys Technology Corp. (CSE: BIOV) (FSE: 5LB0) (OTCQB: [BVAXF](https://marketwirenews.com/stock/bvaxf/)) ("BioVaxys" or the "Company"), a clinical stage biotechnology company focused on developing advanced treatments in oncology, infectious disease, allergy, and other immune diseases based on its DPX™ antigen delivery and immune-educating technology platform, is pleased to announce 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). All patients were followed for two years post-treatment vaccination, and patients with prior immunotherapy including checkpoint inhibitors such as anti-PD1, anti-PDL1, or anti-PDL2, were excluded from the study. ORR was based on RECIST 1.1 criteria.
In the Phase 1 / 2 study, patients with recurrent ovarian cancer received a novel combination of MVP-S, pembrolizumab and intermittent low dose cyclophosphamide. In all, 47 patients were enrolled, 16 in phase 1 dose escalation and 31 patients in phase 2. Regarding primary study endpoints, the ORR was 24% and the DCR was 82% among patients with high grade endometrial cancer, with median duration of response of 5.5 months among responders. Of note, the benefit was more pronounced in patients with platinum-sensitive disease, who achieved an ORR of 40% and a DCR of 90%. Even among patients with platinum-resistant disease, from the phase 1 dose escalation and cohort B (n=24), outcomes exceeded expectations with an ORR of 16% and a DCR of 54%, compared to standard of care single-agent chemotherapy which typically achieves an ORR around 11.8%.^(4)
Of major significance, the longest detected immune response lasted 195 weeks for a patient in Cohort A, with this patient remaining in complete response for 3 years following the first cycle of therapy. MVP-S induced survivin-specific immune responses in 62% tested patients and were correlated with disease control in 93% of patients.
Epithelial ovarian cancer (EOC), characterized by a pattern of relapse and progression through successive recurrences, has overall poor survival due to late detection, high heterogenicity and development of resistance, highlighting the urgent need for novel treatment strategies. 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 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 response^(2). 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. Designed to target and eliminate survivin-expressing tumor cells, BioVaxys' maveropepimut-S (MVP-S) is a DPX-based vaccine immunotherapy that induces a cytotoxic T-cell response. DPX is a non-aqueous, non-systemic, lipid-in-oil immune educating antigen delivering platform that is the foundation of BioVaxys' oncology and infectious disease product pipeline. MVP-S is a DPX-based formulation of five peptides derived from survivin, a T helper peptide, and an innate immune stimulant, which delivers instruction to the immune system to generate a specific, robust, and persistent immune response. MVP-S has been shown to be well tolerated and has demonstrated activation of a targeted and sustained, survivin-specific anti-tumor immune response in multiple cancer indications, such as in BioVaxys' recent phase 1 study of MVP-S with neoadjuvant hormone therapy in HR(+) / HER2(-) stage II-III breast cancer.
Kenneth Kovan, President & Chief Operating Officer of Biovaxys, says: "The combination of MVP-S, pembrolizumab and low dose cyclophosphamide in endothelial ovarian cancer demonstrated promising and sustained clinical activity with good tolerability. 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.
1. Hamanishi J., et al. Nivolumab vs. Gemcitabine or Pegylated Liposomal Doxorubicin for Patients with Platinum-Resistant Ovarian Cancer; Open-Label Randomized Trial in Japan (NINJA). J Clin Oncol. 2021 Nov 20;39 (33):3671-81.
2. Weir GM, Stanford MM, Mansour M, Quinton T, Hrytsenko O, Berinstein NL, Anti-PD-1 increases the clonality and activity of tumor infiltrating antigen-specific T cells induced by a potent immune therapy consisting of vaccine and cyclophosphamide. J Immunotrher Cancer. 2016 Dec;4(1):68
3. Rixe O, et al. Abstract CT035: Safety, preliminary efficacy and pharmacodynamic analysis of MVP-S, intermittent low dose cyclophosphamide, and pembrolizumab in advanced bladder cancer. Cancer Res. 2022 Jun 15;82(12\_Supplement):CT035-CT035.
4. Pujade-Lauraine et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase 3 trial. J Clin Oncol Off J Am Soc Clin Oncol. 2014 May 1;32(132):1302-8.
**About BioVaxys Technology Corp.**
BioVaxys Technology Corp. ([www.biovaxys.com](https://api.newsfilecorp.com/redirect/LqmqOhnojg)), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it's HapTenix© tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization for food allergy, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. 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. MVP-S delivers antigenic peptides from the survivin family, a set of well-recognized cancer antigens commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, DPX+rPA for peanut allergy prophylaxis, and BVX-0918, a personalized immunotherapeutic vaccine using its proprietary HapTenix© 'neoantigen' tumor cell construct platform for refractive late-stage ovarian cancer.
BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FSE: 5LB0) and in the U.S. on the OTC Markets (OTCQB: BVAXF). For more information, visit [www.biovaxys.com](https://api.newsfilecorp.com/redirect/oPqPYT01g1) and connect with us on X and LinkedIn.
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