The future of cancer treatment will likely come in the form of vaccines.
Over recent decades, scientists have developed an understanding of how cancer eludes the immune system, allowing them to test cutting-edge immunotherapies designed to teach our bodies how to recognize and neutralize cancer cells.
These therapies involve teaching T cells, the immune system’s chief enforcers, how to associate cancer with a threat and hunt it down anywhere in the body. This differentiates most cancer vaccines, which are focused on minimizing recurrence and shrinking tumors, from traditional prophylactic vaccines, which prevent diseases from occurring in the first place.
Promising advances in breast, bladder, pancreatic and skin cancer vaccines, as well as mRNA technology, are bringing hope to millions in search of less aggressive and more accurate treatments compared with radiation and chemotherapy. Preventive treatments may also be on the horizon, as vaccines for Hepatitis B have been found to prevent liver cancer, while HPV vaccines have been shown to prevent cervical cancer.
With researchers hard at work across the spectrum of cancer immunotherapy, seasoned investors will be asking themselves how they might participate in these innovations, whose immense potential for eradicating the world’s leading cause of death will surely result in outsized returns for a chosen few.
Introducing BioVaxys, a leader in haptenized cancer vaccines
A key candidate for an allocation is BioVaxys Technology (CSE:BIOV), a clinical-stage biotechnology company developing personalized cancer vaccines utilizing its proprietary Haptenix™ tumor cell neoantigen technology.
Haptenix™ technology is based on haptens, simple chemicals that become immunogenic when attached to proteins, such as tumor antigens. Protein haptenization, pioneered in the 1930s by immunologist and Nobel laureate Dr. Karl Landsteiner, teaches a patient’s immune system to recognize these proteins – in addition to their non-haptenized instances – as foreign, leading to a stronger immune response against them.
Multiple clinical trials with a prior generation of the haptenized antigen vaccine in over 600 patients conducted by David Berd, MD, founder and chief medical officer at BioVaxys, has yielded extensive evidence supporting its treatment of regional and disseminated metastatic tumors, with no observed toxicity.
These highly promising clinical studies led BioVaxys to improve upon the hapten vaccine developed by Dr. Berd through proprietary, value-added technology to address a market whose unmet needs represent billions in untapped revenue: ovarian cancer, with more than 300,000 new diagnoses in 2020.
BVX-0918, a bi-haptenized autologous ovarian cancer vaccine
Using a single hapten to label antigenic proteins for tumor cells modifies hydrophilic amino acids. Berd’s first-generation, single-hapten vaccine produced positive immunological and clinical results in Phase I and Phase II human trials – including more than 600 patients with different tumor types – under FDA-reviewed investigator-sponsored studies.
Berd’s clinical studies also included a haptenized vaccine in women with advanced ovarian cancer that achieved encouraging results, including a median overall survival of 25.4 months over a range of 4.5-57.4 months across 24 patients, with eight surviving for more than two years.
Haptenix’s™ key contribution to immunotherapy vaccines amounts to a supercharging of the haptenization process.
BioVaxys believes it can outperform the prior clinical results with BVX-0918, a bi-haptenized vaccine where two haptens are designed to modify hydrophilic and hydrophobic amino acids, thus increasing the “foreignness” of target tumor antigens to the immune system more than by just a single hapten. This greater foreignness, in turn, puts a greater number of T cells on the offensive, raising the probability of remission.
Despite the revolution in cancer therapy initiated by checkpoint inhibitors in several tumor types, durable clinical responses remain very limited or sporadic in other tumors, such as ovarian cancer. Identifying which antigens are presented by tumor cells and recognized by T cells provides a major step toward novel effective targeted immunotherapies, however, the identity or structure of many ovarian tumor antigens remains elusive. The beauty of BioVaxys’ bi-haptenized approach is that one does not need to know the specific tumor antigens, as haptenization is antigen agnostic.
The company creates its vaccine by removing a patient’s own (e.g. autologous) cancer cells, conjugating the cells with haptens, then injecting them back into the patient, enabling a personalized treatment solution with maximized chances of success.
It plans to improve these chances even further by combining its vaccine with monoclonal antibodies, such as anti-CTLA4 and anti-PDA checkpoint inhibitors, which significantly strengthen immune response on their own, an effect that should only be enhanced by BVX-0918’s unmasking of tumorous environments.
BioVaxys recently completed a sterile and bacteria-free production test-run of BVX-0918, validating production protocols for the extraction of tumor cells, identification of ovarian cancer cells using specially developed monoclonal antibodies and flow cytometry, and the development of a double haptenization process for the ovarian tumor cells used in the vaccine.
Next steps include further optimizing the production process, finalizing requirements for GMP-certified manufacturing, and applying for a CTA, which is the European equivalent of the FDA’s Investigational New Drug application.
In terms of E.U. regulatory approval, the company has completed its clinical study protocol, and its E.U. clinical development and marketing partner, Procare Health Iberia, has selected a clinical research organization and identified Spanish Phase I study investigators.
BioVaxys has another trick up its sleeve, as some of the early data suggests that haptenization may be able to turn “cold” tumors into “hot” tumors, as evidenced by T lymphocyte infiltration of metastatic tumors following administration of its vaccine. Cold tumors are characterized by the absence of stimulatory signals and a low expression of neoantigens, which cause poor tumor immunogenicity, whereas “hot” tumors show signs of inflammation, meaning the tumor has already been infiltrated by T cells rushing to fight the cancerous cells.
Those tumors responding to checkpoint inhibitors have a higher level of immune infiltrates and/or interferon signatures that are indicative of T cell infiltration of the tumor cell. For example, melanoma has very good response rates to checkpoint inhibitors, and is typically referred to as a hot tumor, whereas ovarian cancers have low infiltration, which may explain why checkpoint inhibitors are only marginally effective in ovarian cancer.
The early data suggests that previously “cold” tumors became “hot,” as evidenced by infiltrating CD8+ T cells activated by BioVaxys’ cancer vaccine, with these infiltrating T cells producing gamma interferon. Furthermore, molecular analysis of these infiltrating T cells indicates expansion of specific and novel T cell clones. Additional study is required, but BioVaxys may have a game-changer for tackling resistant “cold” tumors that have stymied other therapeutic approaches. The company is extremely excited with the prospect that treatment with BVX-0918 to stimulate tumor cell infiltration in cold tumors, followed by a checkpoint inhibitor, may result in a game-changing approach to treating ovarian cancer and present partnering opportunities with global pharma possessing approved checkpoint inhibitors such as PD-1 inhibitors.
Given haptenization’s extensive supporting evidence, BioVaxys’ cancer research is a ground-floor opportunity with global reach worth your full due diligence process.
Excessive pessimism creates a golden opportunity
Given the blue-sky potential of BioVaxys’ proprietary haptenization technology, the company’s stock, down by 86 per cent YoY, seems excessively out of favour.
When we consider global macroeconomic conditions, the drop is comprehensible because higher prices and restrictive borrowing costs tend to push investors away from higher-reward small and micro-cap theses toward safer, more dependable cash flows.
But when we consider BioVaxys’ promising research and development, coupled with the stock market’s propensity for temporary dislocations from value, the drop also looks like a bargain, one where increasingly fearful short-term investor sentiment has unfairly punished the company, and others like it, whose long-term potential requires conviction to be realized.
Last trading at C$0.015 per share, an ownership stake in BioVaxys is priced as a gift to anyone ready to coast through the volatility of a clinical-stage, pre-revenue company, whose technology could fundamentally improve the quality of human life across a variety of indications. This rare and free lunch should not be taken for granted as additional research and clinical trials get underway.
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