November 6, 2024 BioVaxys Newsletter Hello everyone!
Since we did not circulate a Newsletter for September, the updates within also include some key events from that month as well.
Expansion of Team - BioVaxys has engaged Rajkannan Rajagopalan, PhD, as Advisor for development and production of the Company's DPX™ formulations.
Most recently, Dr. Rajagopalan was Senior Director of Formulation Development at IMV, Inc., where he developed DPX-based vaccines to treat breast, ovarian, bladder and hard to reach cancers; and DPX-based RSV, Anthrax, ZIKA, Ebola, Tuberculosis and SARS infectious disease vaccines, as well as VLP-encapsulated DPX vaccines to treat Malaria and RSV infections. He also developed the DPX formulations for SurMAGE and KRAS/BRAS antigens to treat bladder and colorectal cancers, and formulation technology to deliver multiple peptides (up to 25 neoantigens) in a single DPX formulation for personalized cancer treatment, and an emulsion technology to co-deliver both small molecules chemotherapeutics and antibodies together for cancer treatments. In addition, Dr. Rajagopalan established that DPX technology can be used as a thermostable platform for vaccines with the inclusion of right additives (sugars and biodegradable polymers). Dr. Rajagopalan holds multiple patents to treat cancer and infectious diseases using DPX technology for the delivery of peptides, proteins, nucleic acids and small molecules.
Dr. Rajagopalan has a PhD in Pharmaceutical Chemistry/Physical Chemistry, with over 20 years of experience in nanoparticles formulation development for biomolecules (peptides, proteins, nucleic acids, VLPs, mAbs) delivery to treat cancer, infectious diseases and autoimmune disorders.
- We are in the process of interviewing candidates to conduct formulation work under the direction of Dr. Rajagopalan. We are hoping to identify this person by end of year.
Collaborations
- BioVaxys has joined The Rapid Response Partnership Vehicle (RRPV), a consortium of large and small biopharma, contractors, government agencies, and academic and non-profit research institutions that support the US Government’s Biomedical Advanced Research and Development Authority (BARDA) in its objective to accelerate Medical Countermeasure product and technology development to address evolving needs including pandemic influenza, emerging infectious diseases, and other biological threats.
RRPV is a multiple-purpose acquisition vehicle to facilitate end-to-end development of future medical countermeasures, from the early stage through the advanced development, procurement, sustainment, and commercialization, including manufacturing infrastructure development. The RRPV is designed to foster and accelerate the speed of acquisition and partnerships in response to pandemics and other biothreat incidents and promotes innovation and rigorous development of medical countermeasures and enabling technologies to further enhance national health security.
A principal focus of the RRPV is to enable targeted product development expertise specifically for vaccines and therapeutics. Proposals are solicited from consortium members for individual project requirements on behalf of BARDA, which will evaluate proposals and authorize RRPV to issue project agreements with Consortium members for individual projects.
The RRPV complements BARDA’s existing solicitation and acquisition vehicles such as the Broad Agency Announcement (BAA), and will expand the mechanisms through which BARDA can rapidly partner with product developers in fields of interest to BARDA, such as improved flu vaccines and platform technologies that enable expedited turn-around for vaccine development.
Consortium members include Astra-Zeneca, Battelle, Deutsches Zentrum fr Infektionsforschung e.V. (The German Center for Infection Research), Genentech, Ginkgo Bioworks, Inc., Novavax and Leidos----to name just a few.
DPX Comparison Study
- In a press release from end of October, BioVaxys shared the DPX exhibits superior immune system activation compared to aqueous and emulsion-based antigen delivery systems recruits and activates unique subsets of antigen presenting cells (“APCs”) to drive immunogenicity of antigens, and exhibits superior immune activation compared to aqueous and emulsion-based antigen delivery systems.
In a study done in collaboration with Dalhousie University of Halifax, Nova Scotia, DPX was compared to aqueous and emulsion-based formulations to evaluate the dynamics of immune cell recruitment to the site of injection, antigen consumption, and trafficking by immune cells. Immune cell composition and antigen uptake at the injection site were assessed by multi-parameter flow cytometry and confocal microscopy using model peptide antigens administered in mice. Antigen-specific immune responses were assessed by interferon-gamma (IFN-γ)-based Enzyme-Linked Immunospot (ELISpot) assay to measure IFN-γ, the presence of which plays a crucial role in activating the immune system. The ELISpot assay is a sensitive method for measuring the number of cells that produce cytokines or antibodies in response to an antigen.
The study results showed that aqueous formulations were poorly able to retain lymphocytes at the injection site and consequently did not elicit a detectable IFN-γ ELISpot response. Both DPX and the oil emulsion were superior in recruiting APCs to the injection site and inducing antigen-specific immune responses, and with significant increases in immune cell infiltration detected as early as 2 days post DPX injection. However, a significant difference between DPX and oil emulsion was that antigen presentation driven by the DPX platform resulted in activation of more critical markers of T cell subsets than emulsion. An additional and highly significant finding is that recruitment and activation of these T cell subsets by DPX was evident regardless of whether an antigen was contained as cargo in DPX, indicating that DPX on its own has immune system activating properties.
DPX in Infectious Diseases
- A Press Release in August highlighted studies showing the potential of our DPX™ platform across multiple infectious diseases. Key findings demonstrated in completed infectious disease studies included:
- In a phase 1 human study for respiratory syncytial virus (RSV),DPX-RSV demonstrated antigen-specific immune responses in 93% of subjects, with100% of responders in the 25μg dose cohort maintaining antigen-specific immunity one year post-vaccination. Our intent is to pursue a development partnership or license agreement for further development with vaccine companies already in the RSV space (i.e. GSK,
- In a pre-clinical murine model, DPX-rHA for influenza achieves higher antibody levels than standard Alum rHA Vaccine and protects against multiple flu strains. The Company is planning an additional preclinical study to now prove that DPX can incorporate a cargo of four different flu antigens with a prospective commercial partner.
- Animal challenge studies with DPX-Based Anthrax vaccine demonstrated100% immunity following a single injection compared to current vaccines which require more than one dose, as well as concomitant administration of a quinolone antibiotic.
BioVaxys has very promising data from studies of DPX formulations in other infectious diseases including Malaria, Zika virus, and a registration-ready data package for a Phase 1-study in Covid (should public health conditions warrant development). We reconnected with well-known Malaria researcher Alexandra Rowe, PhD, Professor of Molecular Medicine, at The University of Edinburgh, who was involved in preclinical research with DPX and who has identified the parasitic proteins that play a critical role in binding to human blood cells. She has expressed interest in further work with BioVaxys on a multi-antigen DPX formulation for Malaria; we will be having further discussions. Although not a major commercial opportunity, Malaria remains high on the list of importance for government agencies and NGO’s, BioVaxys plans to evaluate non-dilutive options, such as via RRPV, as development paths.
The Company plans to seek opportunities with its clinical data in RSV, as well as its preclinical data in multivalent Influenza, Zika, Anthrax, and other infectious diseases through the RRPV/BARDA consortium.
Corporate Partnerships
- Although in early stages, BioVaxys is in discussion with a major Shanghai-based pharmaceutical company with core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation, and technology platforms such as antibodies/ADC, cell therapy, and small molecules---many of which could benefit from the DPX platform. We anticipate being in further stages of due diligence in the coming months including a management trip to China
Licensee Update
- BioVaxys and SpayVac for Wildlife, Inc. ("SpayVac") jointly announced that SpayVac® completed set-up of its new research and production facility in Madison, Wisconsin to produce their long-lasting, single-dose veterinary contraceptive vaccines. They have informed us that they are on track to submit their filing for regulatory approval in 2025, and expect to see commercial sales, which will generate royalty revenue from our liposome-based antigen delivery platform technology.
- SpayVac-for-Wildlife Inc. reached a significant milestone with the first successful scaled-up production run for their animal fertility-control vaccine at the new facility in Madison, Wisconsin. They have informed us that the batch will be used in The Danube River Delta, where it will be used as immunocontraception to help manage the wild horse population in Europe, and an aquaculture study project in Washington state. This is the first time SpayVac will be tested in farm-raised rainbow trout to prevent spawning and also marks the first time such an application has been undertaken anywhere in the world.
- Announced in July 2024, SpayVac-for-Wildlife’s clinical study with the Elephant and Wildlife Clinic, Faculty of Veterinary Medicine at Chiang Mai University in Thailand to test a long-lasting, single contraceptive vaccine on captive Asian elephants continues to generate very good assay data. SPayVac-for-Wildlife, Inc. has also just initiated a study in the EU for immunocontraception in the native deer population.
Formulation
- BIOV is in process of (re)acquiring from Dalhousie Univ ~43Kg of GMP-grade lipids originally developed by IMV, but acquired by the University post-bankruptcy. Having the lipids will give BioVaxys the ability to meet our needs for creating the different DPX formulations needed to conduct our planned preclinical and clinical studies over the next few several year. We would note that it would take more than. 12 months for a CDMO to produce this quantity of lipids.
- BioVaxys is also working with Dalhousie University to lease laboratory space as well as various equipment needed to produce DPX formulations for pre-clinical supply.
Conferences
- BioVaxys has been invited to present at the Personalized Cancer Vaccine Summit to be held December 3-5, 2024, in Boston, MA. The Company plans to present new data from a study previously conducted at the University of Connecticut on DPX stimulating the immune system without any antigen cargo.
- BioVaxys has been invited to participate at the "Investing in Food Allergy Summit” in NYC on April 30th, 2025 sponsored by The Food Allergy Fund (https://foodallergyfund.org). Participants will interact w/ a highly curated audience of leading biotech investors, family offices, and VC firms. The Fund's leadership in identifying and featuring investors, entrepreneurs, and scientists from world-renowned institutions in the food allergy field is unparalleled, and this will be an outstanding opportunity for us to connect with potential investors, partners, stakeholders, and key opinion leaders.
Media
- Chief Executive Officer James Passin and President & COO Kenneth Kovan conducted a live interview on Sept 19, 2024 with Brad Sorensen, Senior Analyst at Zacks Small Cap Research, at the Life Sciences Investor Forum, hosted by OTC Markets and www.VirtualInvestorConferences.com.
Following is a link to the complete interview, which is also posted on the Zacks SCR website:
https://scr.zacks.com/news/news-details/2024/OTC-Markets-Hosts-Virtual-Investor-Presentation-with-James-Passin-Founder--CEO-of-BioVaxys-Technology-Corp-and-Brad-Sorensen-Senior-Analyst-at-Zacks-SCR/default.aspx
- President & COO Ken Kovan was interviewed on 11/5 to address the recent news on the DPX comparative study and BioVaxys joining the BARDA/RRPV collaboration.
Cautionary Statements Regarding Forward Looking Information
This Newsletter 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.
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