Nivolumab

LYON, France--(BUSINESS WIRE)--Regulatory News: Gut dysbiosis is increasingly recognized as a risk factor for immunoresistance to immunotherapy. MaaT033 is designed to restore microbiome balance and may help improve patients’ response to treatment MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced that the first patient has been randomized in the IMMUNOLIFE Phase 2 clinical trial, a randomized multicenter study evaluating the potential of an oral pooled fecal microbiotherapy (MaaT033) in combination with Regeneron’s Cemiplimab (CB) in enhancing disease control rate versus best investigator’s choice (BIC) in patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to PD-1/PD-L1 blockade following antibiotic (ATB) exposure and who present ATB-induced gut dysbiosis. The IMMUNOLIFE trial is evaluating MaaT033 in combination with CB vs BIC in 162 patients with advanced NSCLC who are refractory to immune checkpoint inhibitors (ICIs) and have received antibiotics. Patients are randomized (1:1) to receive either MaaT033 orally for one week prior to each cycle of CB (administered every 3 weeks for 6 months), followed by CB alone, or BIC. The primary objective is to assess whether the combination is associated with an improved disease control rate at 12 weeks compared to BIC. The study includes 14 centres in France, with patient enrolment of approximately 2 years and total CB treatment duration of 2 years. Primary results after 1-year follow-up post-treatment could be expected in late 2030. An interim futility analysis around H1 2027, after the 81st randomized patient. “Gut dysbiosis is increasingly recognized as a risk factor for immunoresistance to immunotherapy. MaaT033 is designed to restore microbiome balance and may help improve patients’ response to treatment,” said Lisa Derosa, MD, PhD at Gustave Roussy and coordinating investigator of the IMMUNOLIFE trial. “We have built substantial evidence in our hemato-oncology programs that complex donor-derived products restore immune homeostasis in the context of pre-existing dysbiosis. This study represents an opportunity to further explore these findings in immuno-oncology in a well-defined patient population expected to show antibiotic-mediated dysbiosis,” said Hervé Affagard, CEO and co-founder of MaaT Pharma. This trial, sponsored by Gustave Roussy, is part of MaaT Pharma’s exploratory strategy launched in 2022, which also includes the PICASSO trial, a Phase 2a randomized controlled trial sponsored by AP-HP in Paris evaluating Xervyteg® (MaaT013) in combination with ICIs, ipilimumab (Yervoy®) and nivolumab (Opdivo®) for patients with metastatic melanoma. The Company has been informed by PICASSO's academic sponsor that topline results could not be available in Q4 2025 (as previously announced) and could now be expected in H1 2026. Overall, IMMUNOLIFE and PICASSO studies aim to contribute to the ongoing assessment of the Company’s research strategy, including indication, treatment line, and patient population. This will also inform on the clinical development of MaaT034, a co-cultured microbiome-based therapy and the Company’s next-generation drug candidate, designed to target large indications in solid tumors. In parallel, data already generated and to be generated during the IMMUNOLIFE consortium will also fuel the Company’s AI platform and support the development of all the Company’s microbiome-based drug candidates. The IMMUNOLIFE consortium includes leading academic institutions such as Gustave Roussy, INSERM, Paris Saclay University, INRAe, Hospital-University Institute (IHU) Méditerranée Infection and biotech companies. The consortium aims to address the challenge of primary resistance to ICI observed in advanced NSCLC patients following antibiotic exposure. The IMMUNOLIFE consortium receives funding from the French National Research Agency (“ANR-21-5 RHUS-0017 IMMUNOLIFE”). For more information on the IMMUNOLIFE (IMMUNOLIFE2) study: NCT07001618 --- About MaaT033 MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA). About MaaT034 MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1. By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer. About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. Forward-looking Statements All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

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--(News - January 20, 2026) - BioVaxys Technology Corp. (CSE: BIOV) (FSE: 5LB0) (OTCQB: 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. 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. 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 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. 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. ( ), 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 and connect with us on X and LinkedIn. ON BEHALF OF THE BIOVAXYS BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +1 740 358 0555 Cautionary Statements on Forward-Looking Information This news release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein, without limitation, statements relating to the future operating or financial performance of the Company, are forward-looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by BioVaxys, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. 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 typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties. Many factors, both known and unknown, could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements and the parties have made assumptions and estimates based on or related to many of these factors. BioVaxys does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by applicable securities laws. To view the source version of this press release, please visit