@Tobias323 News & Updates December 2024 Dear Subscribers, Following are some BioVaxys highlights from over the past few weeks. Formulation • In anticipation of restarting clinical studies of various DPX formulations and initiating new preclinical studies, BioVaxys has acquired a 48 kg supply of GMP-grade lipid to enable long-term production of the Company’s DPX antigen packaging delivery platform. The Company was able to acquire the lipids on very commercially attractive terms, with 48 kg (5kg more than we expected) of lipid anticipated to cover production for any conceivable preclinical or clinical trials over the next several years and save the Company over one year in development manufacturing lead time for this drug substance.
https://www.prnewswire.com/news-releases/biovaxys-secures-gmp-grade-lipid-supply-for-production-of-dpx-based-vaccines-in-advance-of-preclinical-and-clinical-program-ramp-up-302333693.html Conferences • On December 5th, David Berd, MD, Chief Medical Officer of BioVaxys, presented "A Novel Delivery System for Personalized Peptide & mRNA Vaccines for More Targeted Therapies" at The Personalized Cancer Vaccine Summit (formerly known as the mRNA Cancer Vaccine Summit) in Boston, MA. The conference was well attended by top industry players developing individualized approaches in mRNA, DNA, peptide, viral, dendritic cells, and optimizing personalized cancer vaccine approaches with immune-checkpoint inhibitor combinations to combat multiple tumor specific pathways and minimize off-target effects. Dr Berd’s presentation highlighted new data from recent in vivo studies of DPX conducted by Hakimeh Ebrahimi-Nik, DVM, Ph.D., Assistant Professor, Medical Oncology, The Ohio State University Comprehensive Cancer Center. The study data supports further differentiation of our DPX immune educating platform from current aqueous, emulsion, and LNP antigen delivery systems and demonstrated that DPX formulations with tumor-derived peptide neoantigens are highly effective vaccines to inhibit or prevent tumor growth following tumor challenges. DPX formulations were also found to be more effective than mixing with commonly used adjuvants, and DPX formulations were demonstrated to be as effective as the gold standard---bone marrow-derived dendritic cells. A highly significant result of the study is DPX formulations (with a checkpoint inhibitor) without a packaged cargo peptide appear to have meaningful immune stimulating properties on their own.
https://www.prnewswire.com/news-releases/biovaxys-shares-new-data-on-its-dpx-immune-educating-platform-at-personalized-cancer-vaccine-summit-302323633.html Following the presentation, we were approached by multiple academic institutions and companies interested in further discussion of utilizing DPX to package/deliver peptide and mRNA neoantigens, including a major European university with a neoantigen discovery program, and a large public company that develops therapies based on messenger RNA (mRNA), with meetings set up for early January. Collaborations • BioVaxys and a research team at Dalhousie University are currently in research discussions on using DPX to package/deliver multiple neoantigens for undisclosed tumor types. Through December, both parties are working on designing potential study protocols. • BioVaxys has been invited by CEPI (the Coalition for Epidemic Preparedness Innovations) to present on the DPX platform in infectious disease applications---this presentation to a screening team at CEPI is the principal entry process for a funded collaboration.
https://cepi.net/ CEPI is a global partnership working to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats. CEPI’s programs aim to substantially reduce global epidemic and pandemic risk. CEPI’s priority diseases include Influenza, Chikungunya, COVID-19, Ebola, Lassa Fever, MERS, Nipah, Rift Valley Fever, and novel viral threats with epidemic or pandemic potential (also known as “Disease X”) by supporting development of cutting-edge technologies that can accelerate the development of safe, effective and accessible vaccines against emerging disease outbreaks. CEPI was founded by the governments of Norway and India, the Bill & Melinda Gates Foundation, Wellcome Foundation, and the World Economic Forum specifically to fund promising vaccine programs. Our presentation will likely be in January 2025. • A third party has made a personal introduction of BioVaxys to C-level management of a $1,278M global animal health company that develops, manufactures and markets a broad range of veterinary products for farm and companion animal species. This has led to this animal health company tasking their business development team to evaluate the DPX opportunity for current and pipeline products; further clarity on the type of relationship we could be looking at will come with the continuing discussions over the next few weeks. • The BARDA / RRPV solicitation for influenza has been extended to end of January 2025. BioVaxys is looking for RRPV partners with mRNA or peptide influenza antigens for a joint BARDA program proposal.
https://www.rrpv.org/ Grants/Government • BioVaxys has entered into an agreement with Leyton Canada Inc., to identify, prepare, and submit a grant proposal to the National Institutes of Health (NIH) for funding the Company’s DPX-based peanut allergy vaccine program. Grant funding, if awarded, can be used to retroactively pay project-related costs. Leyton Canada is a leading global business advisory firm with one of its major focuses on successfully obtaining federal grant funding.
https://leyton.com/ca/en/ • The National Research Council of Canada is currently working with BioVaxys to identify and introduce the Company to re3searecher in the mRNA field for potential collaborations. Licensees • BioVaxys and SpayVac for Wildlife, Inc. jointly announced that SpayVac for Wildlife, Inc.’s Madison, Wisconsin laboratory and production facility is now fully able to supply its cutting-edge contraceptive vaccines, including its well-established pZP vaccine (“SpayVac®”) and its newest GnRH vaccine for commercial aquaculture and other species. The scaled-up production capacity will support wider SpayVac availability for field trials and market seeding studies, the production ramp-up in preparation for a SpayVac launch in the near future, as well as new antigen formulations tailored for diverse animal contraceptive needs. The ability to produce two different lines of vaccine is a significant advancement following SpayVac for Wildlife’s recent announcement of completing the set-up of its Madison-based research and production facility. Part of our use of proceeds from SpayVac’s ongoing fundraising will be to further scale up so they can produce tens of thousands of vaccines. Recently, large-scale shipments were made by SpayVac for Wildlife to support a major feral horse population management project in Europe, underscoring their commitment to expanding animal population control efforts globally. This follows the production of vaccine for an immunocontraception project in Southeast Asia this past summer. SpayVac continues to build momentum with ongoing trials in collaboration with the U.S. government and the EU, as well as a prominent aquaculture genetics company, focusing on a potential alternative to induced triploidy, which results in sterility but leaves fish more susceptible to disease. About BioVaxys Technology Corp. BioVaxys Technology Corp. (
www.biovaxys.com) is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© "neoantigen" tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization for food allergy, and other immunological diseases. Through a unique and 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, and is 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 survivin, a well-recognized cancer antigen 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 (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit
www.biovaxys.com and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, CEO BioVaxys Technology Corp. +1 740 358 0555 Cautionary Statements Regarding Forward Looking Information This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating 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. These 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 the Company, 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 autologous cell vaccine immunotherapy 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. The Company 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 law.