Advancing Next-Generation Vaccines with the DPX Platform: Unlocking Strong Durable Immune Responses for Infectious Disease and Oncology $BIOV.CN $BVAXF FRA:5LB0
We are thrilled to announce highly promising Phase 1 clinical study results for our DPX™-formulated cancer vaccines, maveropepimut-S (MVP-S) and DPX-SurMAGE, in patients with non-muscle invasive bladder cancer (NMIBC).
Both vaccines were well-tolerated and induced significant systemic antigen-specific T cell responses (measured by IFN-γ ELISPOT), with strong responses observed in 55% of MVP-S participants and notable durability in the dual-antigen DPX-SurMAGE arm.
Led by Dr. Yves Fradet at CHU de Québec-Université Laval, these results highlight the potential of our DPX™ platform to advance immunotherapy for NMIBC patients who have failed prior treatments.
Proud to advance novel oncology solutions! #BladderCancer #Immunotherapy $BIOV $BVAXF
Please note that we will are scheduled to take our website (https://t.co/qVYVEp1jdZ) offline for a short period to conduct maintenance and make some content changes. Our webmaster is looking to have these udates completed by early next week. BioVaxys will continue to share developments via our X and LinkedIn accounts.
A very busy summer / early autumn for BioVaxys business development as we move ahead with the structuring of several collaborations with both big and small biopharma for: MVP-S+anti-PD-1’s, new DPX formulations with recombinant peptides, cryptic antigens / non‑canonical peptides---and a joint proposal submission together with two partnering organizations for the Singleshield Prize (https://t.co/r5WdBMraA2) an $80+ million, multi-stage competition to advance a single-administration vaccine platform for pandemic influenza A(H5N1). DPX enables the single dose capability, and our collaborators provide the antigens and grant preparation/contracting expertise. More to follow.
BioVaxys follows up tomorrow afternoon on a second invite to continue presenting DPX to the U.S. DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPE CBRN). In September we shared proof of concept in ebola, anthrax, RSV, flu, Burkholderia. Tomorrow we focus more on the flexibility to approach multiple threats with one versatile platform. A powerful opportunity to continue to showcase DPX potential to DoD. $BVAXF $BIOV
BioVaxys is pleased to announce its participation as a presenting company at the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference, taking place September 9–10, 2026, in New York City. The Conference brings together public and private growth companies, pioneering innovators, investors and industry professionals across biotechnology, medical devices, pharmaceuticals, and healthcare technology for one-on-one investor meetings, capital markets and financing panels, and networking with institutional investors and family offices. $BVAXF $BIOV
BioVaxys presented this week to the US DoD JPEO (CPE) CBRND on its infectious disease data and capabilities of the DPX platform to enable durable, safe, and more practical vaccines against high priority biological threats. Over 40 civilian and US Army research personnel from CBRND were in attendance.
BioVaxys demonstrated that it is able to address core strategic goals of CBRND: (1) a vaccine platform that provides high tolerability & safety (2) durability, (3) adaptability across a range of pathogens and antigens, (4) scalable production capability (5) a platform that has demonstrated successful manufacturing of phase 1 clinical trial material, and (6) the ability to fit into an architecture requiring a synergistic partnership combining distinct capabilities in antigen expression with vaccine carrier/formulation.
We are excited to have been invited by the US Army Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE CBRND) to present the overall utility of our DPX platform in infectious disease applications, all of the preclinical animal studies with anthrax, filoviruses (EBOV), B. Pseudomallei, and the phase 1 data in RSV. CPE CBRND manages the US Army’s investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs).
Moderna/Merck’s melanoma vaccine success is a major positive for $BIOV $BVAXF
Why? It validates the thesis that therapeutic cancer vaccines + checkpoint inhibitors can materially improve outcomes.
BioVaxys already has clinical experience from the PESCO study combining DPX-delivered tumor antigens + pembrolizumab.
Cancer vaccines are entering a new era—-the value is in the shift to better antigens + better delivery + durable T-cell responses.
That is exactly where $BIOV $BVAXF and DPX is positioned.
BioVaxys, Principal Investigator Carman Giacomantonio, MD, and @DalhousieU yesterday submitted the complete initial application to the Congressionally Directed Medical Research Program targeting acral melanoma. Our joint hypothesis is that #acral#melanoma tumors conditioned with THT will become more susceptible to MVP-S-driven survivin-specific T-cell immunity, and that anti-PD-1 checkpoint inhibition will sustain this response. The concept is straightforward: THT prepares the tumor, MVP-S directs the immune response, and anti-PD-1 helps sustain it. We should hear feedback next month.
The proposal for our collaboration with PI Carman Giacomantonio, MD, of Dalhousie University for the CDMRP Rare Melanoma Program targeting acral melanoma is complete and under University review prior to submission. #Acral#melanoma is a very aggressive subtype of skin cancer that forms on the palms of the hands, soles of the feet, or under the fingernails. Unlike ‘typical’ melanoma, it is not caused by sun exposure and delayed treatment can lead to function-altering surgery or amputation. Our joint hypothesis is that acral melanoma tumors conditioned with Sona Nanotech’s THT will become more susceptible to BioVaxys’ MVP-S-driven survivin-specific T-cell immunity, and that anti-PD-1 checkpoint inhibition will sustain this response. This could present a major breakthrough in acral melanoma therapy.
Burkholderia pseudomallei is a bacterium that causes melioidosis, a serious and potentially fatal infectious disease classified by the CDC as a bioterrorism agent due to its potential for aerosol dissemination, severe clinical impact, and resistance to many antibiotics.
A DPX formulated burkholderia vaccine protected 100% of mice following live bacterial challenge. Mice were administered either two doses of a DPX formulation or three doses of an aqueous Burkolderia vaccine. Mice were subsequently challenged with B. pseudomallei, with a 100% survival rate achieved following vaccination with the DPX candidate.
BIOV is getting together tomorrow with a research group at the University of Florida Emeging Pathogens Institute that has been engaged in UK government & DTRA-funded work on burkholderia vaccines and has expressed interest in DPX formulations.
Congratulations to BioVaxys Principal Investigator Dr. Amit Oza of Princess Margaret Cancer Centre @PMResearch_UHN on receiving the 2026 International Gynecologic Cancer Society (IGCS) Lifetime Achievement Award!
Under Dr. Oza's leadership, the Princess Margaret's gynecologic oncology clinical trials program has become one of the largest and most productive in the world, helping advance landmark studies that led to the global adoption of therapies. This includes trials that assessed PARP (poly [ADP-ribose] polymerase) inhibitors, anti-angiogenic treatments, and the PESCO study, a phase 1B/2 trial to evaluate the safety and efficacy of the combination of BioVaxys' maveropepimut-S (MVP-S) with pembrolizumab (Keytruda™) and low dose cyclophosphamide in patients with recurrent epithelial ovarian cancer.
The award recognizes a career of exceptional contributions to gynecologic oncology through research, clinical leadership, mentorship and international collaboration.
Excellent meeting yesterday with researchers at #Moffit Cancer Center and the Melanoma Research Association to discuss work at Moffit that has resulted in the discovery and sequencing of a growing library of very promising #acral#melanoma neoantigens and #cryptic antigens. Looking forward to evaluation of new #DPX #neoantigen formulations.
Studies have demonstrated that the DPX platform provides complete solubility of multiple neoantigens (at least 14-25) in a single formulation irrespective of their charge, nature and solubility profile and has capacity to deliver more peptides than conventional formulations. A single formulation containing 14 neoantigens generated higher immune response by IFN-γ ELISPOT compared to aqueous formulation containing 14 neoantigens or multiple pools of 3 -4 neoantigens, and elicit an enhanced CD8+ T cell mediated immune response after a single vaccination.
BioVaxys has entered a broad collaborative relationship with The University of Nairob @uonbii, KAVI Clinical Research Institute, to develop DPX-formulated vaccines for zoonotic and other emerging infectious diseases, and to conduct human clinical studies in East Africa. A zoonotic virus is an infectious agent that naturally transmits between animals and humans, such as Rabies, #Ebola, #Anthrax, #WestNile Virus, #Avian Flu, and #ValleyFever.
KAVI is an internationally recognized hub for epidemiological studies, basic science, and robust Phase I-IV clinical trials and translational research for vaccines and treatments targeting diseases such as #HIV, #TB, #HPV, #malaria, #zoonotic diseases, #COVID-19, #RSV, and oncology. KAVI is also a member of the #CEPI Global Centralized Laboratory Network. The collaboration with KAVI will enable access to world-class clinical trial infrastructure in East Africa, deep expertise in communicable and non-communicable diseases, and strategic partnerships with global health organizations like IAVI and CEPI.
BioVaxys President & COO Kenneth Kovan will be attending the BARDA Rapid Response Partnership Vehicle (RRPV) annual member meeting in Washington DC next month. The two-day conference, open only for RRPV members, will include updates from BARDA leadership and division directors on current priorities, upcoming needs, and structured networking to connect with industry and government partners. BioVaxys has requested 1-on-1 meetings with BARDA to discuss DPX-mRNA formulation optimization for priority pathogens, as well as BARDA opportunities for development of a potential DPX pan-filovirus vaccine.
We are very pleased to now have the support of the #Melanoma Research Alliance (MRA) for our CDMRP #acral melanoma proposal. Based in Washington DC, the MRA is the largest non-profit funder of melanoma research. For the CDMRP study we will have access to MRAs melanoma patient registry with disease histories, potential matches to clinical trials, acral melanoma biomarkers/tumor samples, as well as the participation of acral melanoma patient advocates and other MRA resources to provide consumer-focused input.
#BVAXF #BIOV
The proposal for our collaboration with PI Carman Giacomantonio, MD, of Dalhousie University for the CDMRP Rare Melanoma Program targeting acral melanoma is complete and under University review prior to submission. #Acral#melanoma is a very aggressive subtype of skin cancer that forms on the palms of the hands, soles of the feet, or under the fingernails. Unlike ‘typical’ melanoma, it is not caused by sun exposure and delayed treatment can lead to function-altering surgery or amputation. Our joint hypothesis is that acral melanoma tumors conditioned with Sona Nanotech’s THT will become more susceptible to BioVaxys’ MVP-S-driven survivin-specific T-cell immunity, and that anti-PD-1 checkpoint inhibition will sustain this response. This could present a major breakthrough in acral melanoma therapy.
@anon66666667 CPE CBRND is a separate but parallel organization to DTRA and BARDA that is under the 'umbrella' of the US Army, and they have their own discretionary budget. This meeting is not in response to any BAA; its based on a request from CPE CBRND. Hope this helps!
We are excited to have been invited by the US Army Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE CBRND) to present the overall utility of our DPX platform in infectious disease applications, all of the preclinical animal studies with anthrax, filoviruses (EBOV), B. Pseudomallei, and the phase 1 data in RSV. CPE CBRND manages the US Army’s investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs).
The Biovaxys collaboration with Adiverna continues to progress towards our goal of developing DPX-mRNA leptospirosis and rabies vaccines. The effort is currently focused on optimizing DPX's prior demonstrated protection of mRNA and APC uptake with novel AI-generated specific mRNA sequences for these pathogens and direct it to antigen-presenting cells. As non-aqueous DPX formulations offer robust shelf-life integrity compared to traditional LNPs and insulate the mRNA cargo from degradation, it will be a major industry milestone to demonstrate proof-of-product with these pathogens.
We have submitted our proposed program outline for the DPX-rPA anthrax vaccine to Canada NRC-BioMCM.
Can't put ourselves in the minds of the reviewers, but a lot of boxes are 'checked off'....positive preclinical lethal dose respiratory challenge data in primates, the solid safety/tolerability profile of DPX in multiple clinical studies, demonstrated antigen uptake by APCs, listing of anthrax as a priority pathogen by NRC BioMCM, and some top collaborators lined up such as the Canadian Center for Vaccinology and the former lead microbiologist from USAMRIID that worked on Cat biothreat pathogen response.