Welcome to our dedicated page for Biovaxys Technol news (Ticker: BVAXF), a resource for investors and traders seeking the latest updates and insights on Biovaxys Technol stock.
Company Overview
BioVaxys Technology Corp. is a clinical-stage biopharmaceutical company registered in British Columbia, Canada, that focuses on advanced immunotherapies using its proprietary DPX™ immune-educating platform and HapTenix© 'neoantigen' tumor cell construct technology. These innovative platforms are designed to orchestrate targeted, robust, and persistent antigen-specific immune responses, addressing complex challenges in oncology, infectious diseases, and antigen desensitization.
Core Technology and Platforms
The cornerstone of BioVaxys’ approach is the DPX™ platform, a non-aqueous, lipid-in-oil delivery system that facilitates the steady recruitment of antigen presenting cells (APCs) to the injection site. This ensures that antigens—whether peptides, proteins, mRNA, or small molecules—are retained in a manner that promotes prolonged immune stimulation. The unique, 'no release' mechanism of DPX™ contrasts with conventional aqueous or emulsion-based formulations by delivering antigens in a concentrated, targeted fashion.
Complementing DPX™ is the HapTenix© platform, which enables the design of personalized immunotherapeutic vaccines targeting tumor-specific neoantigens. Through these integrated systems, BioVaxys is able to package multiple antigens, supporting research and clinical development across a wide array of therapeutic areas.
Clinical Pipeline and Therapeutic Areas
BioVaxys is currently involved in pioneering clinical studies with its immunotherapeutic candidates. Its portfolio spans several indications including:
- Oncology: Development of vaccine formulations for cancers such as advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL), platinum resistant ovarian cancer, and other tumor types, leveraging both the DPX™ and HapTenix© platforms.
- Infectious Diseases: Utilization of the DPX™ platform in developing vaccines that drive both T cell and B cell responses to combat viral infections, including respiratory pathogens.
- Antigen Desensitization: Addressing immunological disorders through novel approaches that modulate immune responses, with potential applications for food allergies and other conditions.
Market Position and Competitive Landscape
Within the competitive biopharmaceutical landscape, BioVaxys distinguishes itself by integrating a flexible antigen delivery system with targeted immune activation. The company's reliance on robust intellectual property, including patents for low dose volume delivery of B-cell epitopes and innovative formulations, underpins its strategy for partnering and co-development. While challenges such as regulatory approvals and clinical validation are inherent in the biopharmaceutical sector, BioVaxys’ strategic focus on technology-driven immunotherapies positions it as a significant contributor to the evolving field of vaccine technology.
Operational and Business Model Insights
BioVaxys generates value not solely through its clinical programs but also by leveraging its extensive IP portfolio and establishing strategic partnerships. This includes collaborations that extend the application of its proprietary platforms to diverse areas, from animal health (via licensed technologies) to human therapeutic applications. The company operates with a clear emphasis on scientific innovation, rigorous clinical development, and the safeguarding of its intellectual properties, which collectively enhance industry trust and credibility.
Scientific and Technological Credibility
Through numerous preclinical studies and early clinical trials, BioVaxys has demonstrated its capacity to induce sustained immune responses across multiple therapeutic modalities. The depth of their research is supported by detailed immunogenicity assessments and comparative studies illustrating the advantages of the DPX™ platform over traditional delivery methods. This scientific rigor serves as the foundation for future research collaborations and validates their standing as experts in the field of immune-educating technologies.
Conclusion
BioVaxys Technology Corp. offers a comprehensive, technology-driven approach to immunotherapy development, underpinned by its innovative DPX™ and HapTenix© platforms. By addressing key limitations of traditional delivery systems and fostering strategic collaborations, the company continues to contribute valuable insights and solutions within the biopharmaceutical industry. Its emphasis on robust intellectual property, scientific excellence, and methodical clinical development makes it a noteworthy entity for those seeking detailed, unbiased information on cutting-edge immunotherapeutics.
BioVaxys Technology Corp announces presentation by Co-Founder and Chief Medical Officer David Berd at the World Vaccine & Immunotherapy Congress in San Diego from November 30-December 2, 2021. Dr. Berd will discuss the potential of haptenized autologous tumor cell vaccines for cancer treatment and the advancement of haptenized viral antigens against SARS-CoV-2 and other viruses. The presentation is scheduled for December 1, 2021 at 17:10 PST. BioVaxys is advancing its platform for viral and oncology vaccines, including a SARS-CoV-2 vaccine aimed at clinical trials.
BioVaxys Technology Corp. (OTCQB: BVAXF) announced positive results from its in vivo study demonstrating the safety and tolerability of CoviDTH, a diagnostic tool for T-cell response to SARS-CoV-2. Conducted with Inotiv, the study showed no adverse effects at doses significantly higher than human levels, except for mild localized redness. The FDA indicated that animal toxicity studies were not required, allowing BioVaxys to move forward with a combined Phase I/II clinical development program. CoviDTH is noted as a cost-effective, point-of-care diagnostic tool validated by recent clinical studies.
BioVaxys Technology Corp. (OTCQB: BVAXF) announced a presentation of preclinical data for its SARS-CoV-2 vaccine candidate, BVX-0320, at the ISIRV-WHO Virtual Congress on October 19-21, 2021. The poster, authored by Chief Medical Officer David Berd, showcases significant antibody and T cell responses in a murine model. The company is advancing its haptenized viral protein technology and preparing for a clinical trial of its cancer vaccine. BioVaxys emphasizes that it does not claim ability to treat SARS-CoV-2 at this time.
BioVaxys Technology Corp. has initiated an in vivo animal toxicology study of its diagnostic tool, CoviDTH, in conjunction with an upcoming IND submission. The study, carried out by Inotiv, Inc., will assess the safety and toxicity of the SARS-CoV-2 s-protein used in CoviDTH. Although the FDA indicated that animal toxicity studies were not required, BioVaxys believes this data could be useful. CoviDTH is designed to evaluate T-cell immune responses in vaccinated or exposed individuals, reinforcing its potential as a low-cost, point-of-care diagnostic.
BioVaxys Technology Corp. announced the engagement of 6 Degrees, a communications firm, to enhance its strategic communications, public and media relations, and social media efforts. The President & COO, Kenneth Kovan, stated that this decision aligns with BioVaxys's growth and aims to increase public awareness. BioVaxys is focused on developing vaccines and diagnostics for viral and oncology applications, including a SARS-CoV-2 vaccine and cancer therapies. The company holds two US patents related to its cancer vaccine and has pending applications for its COVID-19 vaccine technologies.
BioVaxys Technology Corp. announced on September 20, 2021, that it has engaged 6 Degrees, a life sciences communications firm, to enhance its strategic communications and public relations efforts. The partnership aims to improve BioVaxys's visibility as the company advances its oncology and viral vaccine platforms, including a SARS-CoV-2 vaccine and a cell vaccine for ovarian cancer. BioVaxys holds two U.S. patents related to its cancer vaccine and is pursuing additional patents for its COVID-19 technologies.
BioVaxys Technology Corp. announced significant progress with cancer vaccine BVX-0918A, as manufacturing partner Bio Elpida in Lyon, France, completes key milestones in its development. The process now transitions to the next phase, focusing on a Quality by Design approach while preparing for GMP manufacturing. The vaccine aims to begin a Phase I clinical trial in Spain early next year. CEO Ken Kovan highlighted this achievement as a testament to their manufacturing partners' capabilities and a vital step for BioVaxys in advancing its oncology solutions.
BioVaxys Technology Corp. announced that WuXi Biologics has successfully synthesized recombinant SARS-CoV-2 s-protein for its COVID-19 vaccine candidate BVX-0320 and the CoviDTH immunodiagnostic product. Both products are set for clinical trials, with an IND submission to the FDA for CoviDTH underway. The company has confirmed high yields of the protein, essential for clinical studies, while the FDA noted that a preclinical animal toxicity study is not mandatory for IND submission. BioVaxys continues this study for additional data.
BioVaxys Technology Corp. announced that Dr. Yvelise Barrios presented a study on the durability of T-cell responses to SARS-CoV-2 at the European Congress of Immunology. The study indicates that the DTH response, the basis for BioVaxys' CoviDTH diagnostic tool, can last over a year post-infection. Results showed significant DTH responses in two patients at both six and twelve months. BioVaxys aims to advance its vaccine development, awaiting an IND for a planned Phase I/II study in the US. The DTH test could serve as a routine method for monitoring T-cell immunity.
BioVaxys Technology Corp. has successfully closed the second tranche of its non-brokered private placement, raising approximately $1,176,880 by issuing 5,349,455 units at $0.22 each. Combined with the first tranche completed on July 14, 2021, total proceeds amount to $2,015,555. Each unit comprises one common share and a warrant exercisable at $0.50 for 30 months. The company plans to utilize these funds for research and development and working capital, subject to a four-month hold period for the issued securities.
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