Issued on behalf of BioVaxys Technology Corp.
VANCOUVER – USA News Group – According to the World Health Organization, at least 154 million lives have been saved over the past five decades, thanks to vaccines, leading to the eradication of diseases like smallpox, with polio on the brink of elimination. Research from the Office of Health Economics earlier this year shows that adult vaccination programs can deliver returns of up to 19 times their initial investment. Prioritizing disease prevention naturally requires implementing effective immunization campaigns while also fostering an environment that encourages the development of new vaccine technologies. Behind the scenes, there are several innovators working towards new vaccines and new technologies to deliver them, with recent developments coming from BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT), Gilead Sciences, Inc. (NASDAQ: GILD), GeoVax Labs, Inc. (NASDAQ: GOVX, GOVXW), and Vaxcyte, Inc. (NASDAQ: PCVX).
The article continued: According to analysts at Precedence Research the Global Vaccine Adjuvants Market is predicted to grow to US$2.18 billion by 2034, and projecting that the Oral Vaccine Market will hit US$9.62 billion by 2034, expanding at a 9.54% CAGR. Business Research Insights projects a 19% CAGR for the Global mRNA Cancer Vaccines and Therapeutics Market to touch US$960 million by 2032.
BioVaxys Secures GMP-Grade Lipid Supply for Production of DPX-Based Vaccines in Advance of Preclinical and Clinical Program Ramp-Up
BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), a clinical-stage biopharmaceutical company, recently announced that in anticipation of restarting clinical studies of various DPX formulations and initiating new preclinical studies, it has acquired a 48kg supply of GMP-grade lipid to enable production of its DPX antigen packaging delivery platform.
These unused lipids from the former IMV, Inc. (the intellectual property of which was officially acquired by BioVaxys in February), had been previously produced in advance of anticipated IMV clinical studies and commercial ramp up. In February 2024, BioVaxys acquired 100% of the intellectual property and programs formerly owned by IMV.
BioVaxys' DPX™ technology (DPX), is a patented delivery platform that can package/deliver a range of bioactive molecules, such as mRNA/polynucleotides, peptides/proteins, virus-like particles, and small molecules, to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform, which is non-aqueous and non-systemic, facilitates immune cell recruitment and antigen uptake at the injection site for delivery to regional lymph nodes via Antigen Presenting Cells, stimulating a robust and durable antigen-specific immune response.
"We were able to acquire the lipids on commercially attractive terms, with 48 kg 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 manufacturing lead time for this drug substance," said Kenneth Kovan, President & Chief Operating Officer of BioVaxys.
BioVaxys has also signed a binding LOI to develop DPX™-Based Vaccines for Life Threatening Food Allergies, and has highlighted DPX’s potential across multiple infectious disease studies and announced its plans for partnering and further development.
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In other industry developments and happenings in the market this week include:
Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, recently announced that the U.S. Food and Drug Administration (FDA) has issued a "Study Can Proceed" notification for the Company’s Investigational New Drug (IND) application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The clinical study is funded by Biomedical Advanced Research and Development Authority (BARDA) and designed to enroll approximately 200 healthy adults in the United States.
"Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process," said Joseph Payne, President and CEO of Arcturus. "The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza."
Gilead Sciences, Inc. (NASDAQ: GILD), an antiviral specialist, recently acquired investigational assets related to the HTI therapeutic HIV vaccine from Spanish HIV immunotherapies company AELIX Therapeutics, a spin-off of IrisCaixa. The transaction represented a significant step forward in the development of innovative strategies for curing HIV. Financial details of the deal were not disclosed. Prior to the acquisition, Gilead and AELIX first collaborated in 2018 to investigate AELIX’s vaccine with Gilead’s antiviral vesatolimod in HIV-infected individuals.
The HTI vaccine has undergone Phase I and Phase II clinical trials. In February 2023, AELIX reported positive results from the Phase II AELIX-003 trial (NCT04364035), confirming the study achieved its primary and secondary endpoints for safety, tolerability, and immunogenicity. The trial assessed the vaccine in combination with vesatolimod in individuals with HIV receiving antiretroviral therapy.
In December 2022, the FDA approved Gilead’s Sunlenca (lenacapavir) as a treatment for HIV patients with resistance to other medications. Lenacapavir, the active ingredient in Sunlenca, is also being studied in the PURPOSE-1 (NCT04994509) and PURPOSE-2 clinical trials as a PrEP medication, aimed at reducing the risk of HIV infection in HIV-negative individuals.
GeoVax Labs, Inc. (NASDAQ: GOVX, GOVXW), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, recently announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for its patent titled “Vaccinia Viral Vectors Encoding Chimeric Virus Like Particles.” The patent strengthens GeoVax’s intellectual property for its MVA-VLP platform, which expresses tumor-associated antigens (TAAs) in virus-like particles. This includes its MUC1 immunotherapy candidate, MVA-VLP-MUC1, targeting cancers such as breast, colon, ovarian, prostate, pancreatic, and lung. In preclinical studies, MVA-VLP-MUC1 combined with anti-PD-1 showed a 57% reduction in tumor growth, while a preventive model demonstrated 100% tumor growth prevention compared to untreated controls.
“This patent allowance adds to our growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 120 granted or pending patent applications spread over 24 patent families,” said David Dodd, President and CEO of GeoVax. “The initial results with our MVA-VLP-MUC1 immunotherapy candidates have been encouraging. We believe our MVA vector platform is well-suited for development of therapeutic cancer vaccines based on the expression of tumor-associated antigens such as MUC1 and Cyclin B1, among others.”
Vaxcyte, Inc. (NASDAQ: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, recently announced the initiation of the Phase 2 study of VAX-31 in healthy infants and that the first study participants have been dosed. This study is evaluating the safety, tolerability and immunogenicity of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). Vaxcyte expects to share topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later.
“The initiation of the VAX-31 Phase 2 infant study marks a significant milestone as we continue advancing our PCV clinical programs, which also include the fully enrolled, ongoing VAX-24 Phase 2 infant study,” said Grant Pickering, CEO and Co-founder of Vaxcyte. “PCVs are vital to combating Streptococcus pneumoniae, a serious public health threat exacerbated by increasing antimicrobial resistance. As the broadest-spectrum PCV candidate in the clinic today, VAX-31 has the potential to expand coverage and provide protection against both currently circulating and historically prevalent serotypes. We look forward to sharing topline data for safety, tolerability and immunogenicity from the VAX-31 Phase 2 infant study’s primary immunization series in mid-2026, and from the booster dose approximately nine months later.”
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