The Next Ten Bagger In Canadian Biotech

... BioVaxys

Based in Vancouver, BioVaxys Technology Corp. (CNSX: BIOV) is a British Columbia registered, clinical-stage biotechnology company that is developing anti-viral and oncology vaccines based on its proprietary haptenized protein platform technology.  The Company is currently advancing a SARS-CoV-2 vaccine candidate which is in preclinical development, and near-term is planning a clinical trial of its haptenized autologous cell therapy used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors in advanced ovarian cancer.  BioVaxys has licensed two issued US patents, applied for two wholly-owned patent applications related to its cancer vaccine, and has a patent application pending for its antiviral vaccine platform which includes use in SARS-CoV-2 (Covid-19)  BioVaxys common shares trade on the CSE under the stock symbol “BIOV.”

Biovaxys’ Innovation

Cancer and vaccines

• The potential for immunotherapeutic vaccines to treat cancer has been explored over the last 30 years. In general, cancer vaccines typically work by stimulating the body’s immune system to recognize and destroy cancerous cells by targeting tumor antigens that are unique to a patient’s individual tumor.  
• Tumor cells from the same type of cancer can be very different among cancer patients and may not always present the exact same antigen targets, which is why most previous cancer vaccines have failed. 
• Similar to cancer vaccines, viral vaccines work by targeting a protein that is specific to a particular virus.   
• Identification of tumor (or virus)-specific antigens is important to ensure that the vaccine directs cytotoxic (“cell killing”) immune cells directly to the tumor and away from normal, healthy cells.  
• In the context of developing antiviral or anticancer vaccines, use of a hapten “teaches” the patient’s immune system to recognize and target virus or tumor antigens by making the hapten-modified (“haptenized”) antigens more “visible” to the immune system (more so than if the antigen alone was presented to the immune system).
• “Haptenizing” tumor cells ensures that the immune response is against the entire set of tumor antigens, not just the ones that scientists have identified.   
• The beauty of haptenized vaccine development is that it is a scalable platform for any virus or cancer cell, is based on established science, and a well-understood mechanism of action

Novel, scalable immunotherapy strategy

• “Bi-haptenization” - Biovaxys is the only immune-oncology company utilizing haptens attached to the patient’s own tumor cell to enhance the immune response.  The Company believes that its proprietary approach of using two haptens increases the likelihood that the immune system recognizes and destroys the cancer that the vaccine is directed against.
• Anti-CTLA4 and Anti-PDA Antibodies combination therapy - Biovaxys’ novel strategy involves combining immune “checkpoint inhibitor” antibodies (i.e. anti-CTLA4 and anti-PDA) that remove the “brakes” on the immune system that tumors exploit to evade detection and destruction by the immune cells with its haptenized vaccine that makes the tumor more recognizable as “foreign.” This therapeutic strategy hits the tumor with a 1-2 punch.
• Simplified manufacturing and de-risked regulatory - Biovaxys’ manufacturing process for vaccine development is extremely well-defined, involving 4 simple steps, with it’s vaccine platfrom backed by the very promising clinical data in over 500 patients fromt the first-generation haptenized autologous melanoma and haptenized autologous ovarian cancer vaccines. 
• Scalable platform - Biovaxy’s platform is highly-scalable and customizable for many other solid tumor types and viral diseases (which is one of the reasons that they are undervalued at this stage in their lifecycle). Haptenized protein technology is well-established and well-defined in prior clinical studies, and Biovaxy’s unique approach to “haptenize” tumor cell s or viral antigens to deliver more potent, targeted vaccines can be used to address many other viruses and cancers.

Expansive pipeline and de-risked development

• Biovaxys’ antiviral and anticancer vaccine development platforms are an extension of the protein haptenization and vaccine development efforts by BioVaxys co-founder and clinical oncologist David Berd, MD, previously a cancer researcher and clinician with Thomas Jefferson University and Chief Medical Officer at former cancer vaccine company Avax Technologies, Inc.
• Between Dr. Berd’s work at Thomas Jefferson University and at Avax, over $100M in research and development of haptenized vaccines had been committed to advance first-generation haptenized autologous melanoma and haptenized autologous ovarian cancer vaccines through Phase II clinical development, obtaining clinical data in over 500 patients.
• Biovaxys recently licensed the patents related to this first generation haptenized vaccine technology from Thomas Jefferson University, with the mission of enhancing the core technology through state-of-the-art immunology.
• Biovaxys has two concurrent immunotherapeutics under development: a haptenized protein vaccine for COVID-19 currently in preclinical development, and a haptenized autologous ovarian cancer vaccine which is at pre-IND stage.  BVX-0918B, the Company’s melanoma vaccine candidate, is also a pre-IND-stage candidate.
  

• BVX-0320 - a provisional patent application for the Haptenized SARS-CoV-2 Spike Protein Vaccine has been filed (3/20/20) and the manufacturing protocol for non-GMP BVX-0320 has been developed. Biovaxys is conducting a small-animal tolerability, immune response, and T-cell activation studies to confirm the safety and tolerability of BVX-0320 in animals and the bioactivity of the vaccine.
• BVX-0918A vaccine for ovarian cancer is BioVaxys’ improved variant of the first generation haptenized autologous vaccine developed by Dr Berd at Thomas Jefferson University (Fig 1:  First generation ovarian cancer vaccine)
• BVX-0918B BioVaxys’ improved variant of the first generation haptenized autologous vaccine developed by Dr Berd at Thomas Jefferson University’s, for melanoma. (Fig 2: First generation melanoma vaccine).

Investment Considerations

Clearly-defined trajectory and upcoming catalysts 

Tight share structure and insider ownership

Experienced management 

Founders and C-level management all hail from prior experience in founding, funding, or leading R&D at the former Avax Technologies. They have decades’ worth of experience in immunotherapeutic R&D and biotech corporate and commercial development, with ties to institutional capital and Key Opinion Leaders in the field. Notably, James Passin, Co-Founder and CEO, is a former hedge fund and PE fund manager, and a long-term biotech investor. Kenneth Kovan, Co-Founder, President & COO, is a former biotech CEO, and has over 30 years of experience in biopharma commercialization and corporate development. David Berd, M.D., the inventor of both Biovaxys cancer vaccines, is a medical oncologist and tumor immunologist who has experience in clinical oncology research and has published over 85 papers on the subject. In addition to his academic research, Dr. Berd has 10 issued patents dealing with cancer vaccines. As National Director for Immunotherapy at Cancer Treatment Centers of America, Dr. Berd investigated the application of the AC vaccine to ovarian cancer and is a highly-respected medical doctor and academic researcher in the oncology community.

Patents and barriers to entry

Biovaxs’ patent portfolio encompasses their proprietary haptenized protein viral vaccine platform (#62/992,722 filed 3/20/2020), the composition of matter and methods of use for bihaptenized autologous cancer vaccines in combination with immune checkpoint inhibitors (#62/735,381 filed 9/24/2018 and #62/746,066 filed 10/16/2018), and a diagnostic for identifying the T-cell immune response to SARS-CoV-2 infection.  The company has licensed two additional patents from Thomas Jefferson University encompassing the composition of haptenized tumor cells and extracts, the methods for preparing the extracts, the vaccines comprising haptenized tumor cells, methods for treating cancer with the aforementioned vaccines (Issued US patent # 7,297,330), and the cryopreservation of haptenized tumor cells (Issued US patent # 8,435,784).

Market and innovation

Cancer remains one of the most significant burdens to human health and well-being with over 14 million new cases diagnosed per year worldwide resulting in over 8 million deaths. Biovaxys’ cancer vaccine development platform is being optimized for ovarian cancer and melanoma but is extendable to any cancer that can be isolated from the human body. The company has developed a scalable platform that relies on their proprietary knowledge of haptenization of cancer antigens and the preparation of those haptenized antigens into vaccines.  BioVaxys’ virus vaccine technology is currently directed against COVID-19 but is also a platform technology that should be applicable to other human viruses.

Read MedicalGold’s full-length feature article.

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Disclosure

Author owns BIOV.CA shares at the time of publishing and may choose to buy or sell at any time without notice. Author has been compensated for marketing services by Biovaxys Technology Corp.