$BVAXF Update on 1Q2026 initiatives, including collaborations and non-dilutive funding programs.
The Company is pleased to announce that it is participating in a Request for Information (RFI) solicitation issued by the US Government's Biomedical Advanced Research and Development Authority (BARDA) for transformative ‘New Vaccine Platforms’ that can enable efficient development timelines in response to emerging infectious disease threats. BARDAs mission is to accelerate medical countermeasure product and technology development to address evolving needs including pandemic influenza, emerging infectious diseases, and other biological threats. The RFI issued by BARDA is the precursor to a subsequent Request for Proposal (RFP), which is issued following BARDA’s assessment of novel vaccine platforms submitted during the RFI process. Having a role at the start during the RFI process ensures that the capabilities of BioVaxys’ DPX platform are considered when designing the development program needs for the RFP.
Through high-level introductions by the BioVaxys Board, the Company recently initiated discussions for a vaccine development collaboration with a United Nations-chartered international organization dedicated to discovery, development, and delivery of safe, effective, and affordable vaccines for global health initiatives. With a research budget of nearly US$120M, the organization is working to address unmet needs for Shigella, Hep B, Influenza, RSV, Rotavirus, ZIKA, HPV, and other globally critical pathogens. Kovan adds “Attributes of ourDPX platform that are attractive to their vaccine development efforts include features such as duration of immune-activity, single-dosenon-systemic delivery, shelf stability, and micro-dosing capabilities. DPX is uniquely positioned as a solution for antigen packaging and delivery for vaccines urgently needed in both the developed and developing world.” The Company anticipates further developments over the next several weeks as discussions continue.
Last month the Company shared that it was working with an additional prospective partner in the animal health field to advance a research collaboration for a proof-of-product program to evaluate a DPX™ formulation of a proprietary mRNA sequence for diseases requiring long-duration protection, such as rabies. “Since early January, we are jointly reviewing the study design and timelines for a DPX-mRNArabies vaccine program, in anticipation that the protocol is to be finalized and shortly announced. The Company says it’s already established that DPX provides enhanced in vitro and in vivo stability of packaged mRNA, attracts a therapeutically unique subset of Antigen Presenting Cells (APCs) to the injection site for targeted uptake of mRNA by the immune system, and that immunization with DPX containing m RNA induces specific immune responses towards encoded antigen. Gaining additional preclinical data with a DPX-mRNA rabies formulation not only expands our pipeline, but we expect it to open new partnering discussions in the human mRNA vaccine space,” noted Kenneth Kovan, BioVaxys President and Chief Operating Officer.
BioVaxys recently announced positive results from a phase 1 clinical study of MVP-S with neoadjuvant hormone therapy in HR+ / HER2- stageII-III breast cancer, and positive Phase 1 study results with theirDPX-SurMAGE and maveropepimut-S (MVP-S) cancer vaccines in patients with multiple previous recurrences of high grade non-muscle invasivebladder cancer (NMIBC), where treatment with either MVP-S orDPX-SurMAGE was shown to be well tolerated with both products inducing significant systemic antigen-specific T cell responses. After an average two years of follow-up post-treatment, many of the sehigh-grade NIMBC patients were free of recurrence. This simple and well tolerated approach may be a valuable alternative to the many intravesical and systemic treatments currently being developed.
BioVaxys is reviewing data with Principal Investigators from an additional phase 1B/2 clinical study with MVP-S in a different formulation combination and anticipates results in the upcoming weeks.
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 doe snot 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 is pleased to announce that it is participating in a Request for Information (RFI) solicitation issued by the US Government's Biomedical Advanced Research and Development Authority (BARDA) for transformative ‘New Vaccine Platforms’ that can enable efficient development timelines in response to emerging infectious disease threats. BARDAs mission is to accelerate medical countermeasure product and technology development to address evolving needs including pandemic influenza, emerging infectious diseases, and other biological threats. The RFI issued by BARDA is the precursor to a subsequent Request for Proposal (RFP), which is issued following BARDA’s assessment of novel vaccine platforms submitted during the RFI process. Having a role at the start during the RFI process ensures that the capabilities of BioVaxys’ DPX platform are considered when designing the development program needs for the RFP.
Through high-level introductions by the BioVaxys Board, the Company recently initiated discussions for a vaccine development collaboration with a United Nations-chartered international organization dedicated to discovery, development, and delivery of safe, effective, and affordable vaccines for global health initiatives. With a research budget of nearly US$120M, the organization is working to address unmet needs for Shigella, Hep B, Influenza, RSV, Rotavirus, ZIKA, HPV, and other globally critical pathogens. Kovan adds “Attributes of ourDPX platform that are attractive to their vaccine development efforts include features such as duration of immune-activity, single-dosenon-systemic delivery, shelf stability, and micro-dosing capabilities. DPX is uniquely positioned as a solution for antigen packaging and delivery for vaccines urgently needed in both the developed and developing world.” The Company anticipates further developments over the next several weeks as discussions continue.
Last month the Company shared that it was working with an additional prospective partner in the animal health field to advance a research collaboration for a proof-of-product program to evaluate a DPX™ formulation of a proprietary mRNA sequence for diseases requiring long-duration protection, such as rabies. “Since early January, we are jointly reviewing the study design and timelines for a DPX-mRNArabies vaccine program, in anticipation that the protocol is to be finalized and shortly announced. The Company says it’s already established that DPX provides enhanced in vitro and in vivo stability of packaged mRNA, attracts a therapeutically unique subset of Antigen Presenting Cells (APCs) to the injection site for targeted uptake of mRNA by the immune system, and that immunization with DPX containing m RNA induces specific immune responses towards encoded antigen. Gaining additional preclinical data with a DPX-mRNA rabies formulation not only expands our pipeline, but we expect it to open new partnering discussions in the human mRNA vaccine space,” noted Kenneth Kovan, BioVaxys President and Chief Operating Officer.
BioVaxys recently announced positive results from a phase 1 clinical study of MVP-S with neoadjuvant hormone therapy in HR+ / HER2- stageII-III breast cancer, and positive Phase 1 study results with theirDPX-SurMAGE and maveropepimut-S (MVP-S) cancer vaccines in patients with multiple previous recurrences of high grade non-muscle invasivebladder cancer (NMIBC), where treatment with either MVP-S orDPX-SurMAGE was shown to be well tolerated with both products inducing significant systemic antigen-specific T cell responses. After an average two years of follow-up post-treatment, many of the sehigh-grade NIMBC patients were free of recurrence. This simple and well tolerated approach may be a valuable alternative to the many intravesical and systemic treatments currently being developed.
BioVaxys is reviewing data with Principal Investigators from an additional phase 1B/2 clinical study with MVP-S in a different formulation combination and anticipates results in the upcoming weeks.
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 doe snot 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.
