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BioVaxys Reports Positive Phase 2 Data for Maveropepimut (MVP-S) + Pembrolizumab and Low-Dose Cyclophosphamide in Metastatic Bladder Cancer

Source: TheNewsWire

(TheNewswire)

 

Reinforces Synergistic Potential andExpands Opportunity Beyond Ovarian Cancer

 

VANCOUVER, BC – TheNewswire- January 29, 2026 / TheNewswire / - BioVaxysTechnology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB:BVAXF)(“BioVaxys" or the "Company"), a clinical stagebiotechnology company focused on developingadvanced treatments in oncology, infectious disease, allergy, andother immune diseases based on its DPX™ antigen delivery andimmune-educating technology platform, today announced positivefindings from a Phase 2 clinical study evaluating maveropepimut-S(MVP-S) in combination with pembrolizumab and low-dosecyclophosphamide in patients with advanced or metastatic bladdercancer.  These results build on the Company’s recent Phase 1B/2data in advanced ovarian cancer and further validate the potential ofMVP-S to enhance checkpoint inhibitor activity across multiple solidtumor indications.

The Phase 2 study, led by Oliver Rix, MD, PhD, Founder,Director, and Principal Investigator at Quantum Santa Fe, and ClinicalResearch Professor of Medicine at the University of New MexicoComprehensive Cancer Center, assessed the safety, tolerability, andclinical activity of the combination regimen in patients withmetastatic bladder cancer, including those who had progressed on prioranti-PD1/PD-L1 therapies.

Key Findings:

  • Of 17 evaluable subjects, five showed objectiveresponses: 2 confirmed complete responses (CRs) and 3 partialresponses (PRs). 

  • Notably, three responders—including both confirmedCRs—had previously progressed on prior checkpoint inhibitor therapy,suggesting the combination may overcome resistance in refractorysettings. 

  • Several patients achieved durable clinical benefit,with one remaining on treatment beyond 18 months. 

  • The regimen was well tolerated 

  • Immunological data showed increases insurvivin-specific T cells in peripheral blood, consistent with the DPXmechanism of action that promotes a targeted, cytotoxic T-cellresponse. 

These outcomes align with emerging evidence thatcombining MVP-S with checkpoint inhibitors can expand antigen-specificT cell responses, reduce regulatory T-cell activity, and amplifyanti-tumor activity.  Survivin, a tumor-associated antigenoverexpressed in bladder cancer, ovarian cancer, and othermalignancies—but minimally expressed in normal tissues—serves asan ideal target for this approach.

MVP-S is a DPX-based immunotherapy comprising multiplesurvivin-derived peptides, a T-helper peptide, and an innate immunestimulant. The DPX platform employs a novel, non-aqueous, lipid-in-oilformulation that promotes efficient antigen uptake and enablesin vivoimmune programming that mimics natural immune processes, resulting ina robust T-cell activation and durable response without systemicrelease at the injection site.

Kenneth Kovan, President & Chief Operating Officerof BioVaxys, commented: “Building on the promising results from therecent Phase 1B/2 study of MVP-S plus pembrolizumab in ovarian cancer,this Phase 2 bladder cancer data reinforces the synergistic potentialof combining MVP-S with anti-PD1 therapy.  The encouragingactivity—including complete responses in checkpoint-refractorypatients—highlights survivin as a compelling target and strengthensthe rationale for advancing MVP-S toward Phase 3 development inovarian cancer and exploring broader partnering opportunities acrossadditional indications.”

Merck’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo(nivolumab), the dominant anti-PD1 cancer therapies, are nearing asignificant patent cliff by 2028, with Libtayo (cemiplimab),Roche/Genentech’s Tecentriq (atezolizumab) and Astra Zeneca’sImfinzi (durvalumab), also facing patent expirations within the nextsix years and looking for new data to help maintain their marketleadership.  Kovan adds: “Together with the 200-plus drugcandidates in the PD-1 and PD-L1 Inhibitor pipeline, this represents atremendous opportunity for MVP-S.”

BioVaxys continues to advance its infectious disease and oncologypipelines, with MVP-S demonstrating consistent tolerability andantigen-specific immune activation across multiple cancer indications,including recent positive data in HR(+) / HER2(-) stage II-III BreastCancer, non-muscle invasive bladder cancer, relapsed/refractoryDiffuse Large B-Cell Lymphoma, and recurrent epithelial OvarianCancer.

 

About BioVaxys TechnologyCorp.

BioVaxys Technology Corp. (www.biovaxys.com), a biopharmaceuticalscompany registered in British Columbia, Canada, is a clinical-stagebiopharmaceutical company dedicated to improving patient lives withnovel immunotherapies based on the DPX™ immune-educating technologyplatform and it's HapTenix© tumor cell construct platform, fortreating cancers, infectious disease, antigen desensitization for foodallergy, and other immunological diseases. Through a differentiatedmechanism of action, the DPX™ platform delivers instruction to theimmune system to generate a specific, robust, and persistent immuneresponse. The Company's clinical stage pipeline includesmaveropepimut-S (MVP-S), based on the DPX™ platform, in phase IIBclinical development for advanced Relapsed-Refractory Diffuse Large BCell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-Sdelivers antigenic peptides from the survivin family, a set ofwell-recognized cancer antigens commonly overexpressed in advancedcancers, and also delivers an innate immune activator and a universalCD4 T cell helper peptide. MVP-S has been well tolerated and hasdemonstrated defined clinical benefit in multiple cancer indicationsas well as the activation of a targeted and sustained,survivin-specific anti-tumor immune response. BioVaxys is alsodeveloping DPX™+SurMAGE, a dual-targeted immunotherapy combiningantigenic peptides for both the survivin and MAGE-A9 cancer proteinsto elicit immune responses to these two distinct cancer antigenssimultaneously, DPX™-RSV for Respiratory Syncytial Virus, DPX+rPAfor peanut allergy prophylaxis, and BVX-0918, a personalizedimmunotherapeutic vaccine using its proprietary HapTenix©'neoantigen' tumor cell construct platform for refractivelate-stage ovarian cancer.

BioVaxys common shares are listed on the CSE under the stock symbol"BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and inthe U.S. on the OTC Markets (OTCQB:BVAXF). For more information, visitwww.biovaxys.com and connect with us on X and LinkedIn.

 

ON BEHALF OF THE BIOVAXYSBOARD

 

Signed "JamesPassin"

James Passin, Chief ExecutiveOfficer

Phone: +1 740 358 0555

 

Cautionary Statements on ForwardLooking Information

 

This news release includes certain"forward-looking information" and "forward-lookingstatements" (collectively "forward-looking statements")within the meaning of applicable securities legislation. Allstatements, other than statements of historical fact, included herein,without limitation, statements relating to the future operating orfinancial performance of the Company, are forward-looking statements.Forward-looking statements are frequently, but not always, identifiedby 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 beachieved.  There can be no assurance that such statements will proveto be accurate, and actual results and future events could differmaterially from those expressed or implied in such forward-lookingstatements.

Forward-looking statements reflectthe beliefs, opinions and projections on the date the statements aremade and are based upon a number of assumptions and estimates,primarily the assumption that BioVaxys will be successful indeveloping and testing vaccines, that, while considered reasonable byBioVaxys, are inherently subject to significant business, economic,competitive, political andsocial uncertainties and contingencies including, primarily butwithout limitation, the risk that BioVaxys' vaccines will notprove to be effective and/ or will not receive the required regulatoryapprovals. With regards to BioVaxys' business, there are a numberof risks that could affect the development of its biotechnologyproducts, including, without limitation, the need for additionalcapital to fund clinical trials, its lack of operating history,uncertainty about whether its products will complete the long, complexand expensive clinical trial and regulatory approval process forapproval of new drugs necessary for marketing approval, uncertaintyabout whether its DPX platform can be developed to produce safe andeffective products and, if so, whether its vaccine products will becommercially accepted and profitable, the expenses, delays anduncertainties and complications typically encountered by developmentstage biopharmaceutical businesses, financial and developmentobligations under license arrangements in order to protect its rightsto its products and technologies, obtaining and protecting newintellectual property rights and avoiding infringement to thirdparties and their dependence on manufacturing by third parties.

Many factors, both known andunknown, could cause actual results, performance or achievements to bematerially different from the results, performance or achievementsthat are or may be expressed or implied by such forward-lookingstatements and the parties have made assumptions and estimates basedon or related to many of these factors. BioVaxys does not assume anyobligation to update the forward-looking statements of beliefs,opinions, projections, or other factors, should they change, except asrequired by applicable securities laws.

   

Copyright (c) 2026 TheNewswire - All rights reserved.

BioVaxys Technology Corp.

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