With an estimated 12,600 new cases of bladder cancer in Canada in 2025, plus almost 84,870 in the United States, ranking 5th and 10th among the leading domestic causes of cancer death, respectively, it may come as a surprise that the standard of care treatment for the earliest stage of the disease, known as non-muscle invasive bladder cancer (NMIBC), leaves much to be desired in terms of effectiveness and patient quality of life.
The treatment for NMIBC, representing about 75 per cent of bladder cancer cases, is an immunotherapy known as Bacillus Calmette-Guérin (BCG), a version of the tuberculosis vaccine, which is designed to destroy cancer cells and delivered directly into the bladder. While non-invasive and entailing minimal side effects, BCG is only effective in about 70 per cent of patients, with as much as 40 per cent suffering cancer recurrence within 1 year and 20 per cent worsening to deeper-penetrating muscle-invasive bladder cancer (MIBC) – representing the remaining 25 per cent of cases – often requiring bladder removal.
This considerable gap in the bladder cancer market, which GlobalData expects to more than quintuple from US$3 billion in 2023 to US$16 billion in 2033, illustrates an asymmetric opportunity for drug developers to advance new formulations with the promise of extending and enhancing patient longevity.
Introducing BioVaxys
A micro-cap company combining a promising drug pipeline with irrational investor pessimism is BioVaxys Technology (CSE:BIOV), a Canadian clinical-stage biopharmaceuticals developer specializing in immunotherapies across a variety of applications, including oncology and infectious diseases, backed by more than 120 patents acquired from IMV Inc. in 2024 spanning discovery, pre-clinical and clinical-stage assets representing more than 25 years of research and more than US$200 million invested.
This article is disseminated in partnership with BioVaxys Technology Corp. It is intended to inform investors and should not be taken as a recommendation or financial advice.
BioVaxys’ asset portfolio is supported by IMV’s DPX antigen-delivery and immune-educating platform, whose ability to deliver bioactive molecules into the body, with efficiency leaps and bounds beyond the standard of care, reveals BioVaxys stock, down by more than 60 per cent since acquiring IMV’s assets, to be at a bargain price for exposure to vaccines with early indications of added value in multi-billion-dollar markets, including bladder cancer.
The DPX antigen-delivery and immune-educating platform
BioVaxys’ DPX platform represents a concerted step forward for vaccine development, given its ability to trigger targeted, long-lasting immune responses while incorporating a diversity of bioactive molecules, including mRNA/polynucleotides, peptides/proteins, virus-like particles and other small molecules, all of which carry antigens that help the immune system recognize harmful foreign entities by recruiting B Cells and T Cells to remove them from the body.
DPX’s mechanism of action delivers instructions to the immune system in a non-systemic fashion, meaning it does not release active ingredients at the site of the injection; rather, it deploys lipid-in-oil, non-emulsion formulations that mimic natural immune system uptake, avoiding the common drawbacks of standard aqueous or emulsion-based antigen-delivery methods, as detailed in slide 9 of BioVaxys’ November 2025 investor presentation, including:
- Limited cargo delivery due to leakage from affected tissues, leading to antigen waste, poor lymph node targeting and sub-optimal immune system engagement.
- Impractically large particle sizes exceeding 100 nm.
- Poor stability of months to minutes at 5 degrees centigrade.
The DPX delivery method comfortably surpasses these parametres, as shown in a study with Dalhousie University in Halifax, offering 5-10 nm, no-leak particles, stable for more than 3 years at 5 degrees centigrade, which target the lymph nodes and play an active role in antigen-presenting cells, including B Cells, whose role as wanted posters for antigens suspected of invading the body tell T Cells what to attack.
The platform’s safety, tolerability and effectiveness has been demonstrated in numerous preclinical, phase 1 and phase 2B clinical studies (slide 10), substantiating its utility for novel formulations – driven by neoantigens created through BioVaxys’ proprietary HapTenix tumor cell construct platform – that offer more efficient dosing, duration and applicability than their aqueous or emulsion-based counterparts. A pair of vaccines stand out as BioVaxys’ most prospective offerings on the oncology front. Here’s a breakdown:
The DPX+SurMAGE vaccine
BioVaxys’ DPX+SurMAGE immunotherapy carries and is designed to elicit a dual immune response from tumor-associated antigens belonging to the survivin and MAGE-A9 cancer proteins, the former overexpressed in almost all human malignancies, while the latter is frequently expressed in lung and kidney cancer, as well as NMIBC.
DPX+ SurMAGE’s strong preclinical and limited phase 1 safety and tolerability data, which we’ll get into later in the article, speaks to the DPX platform’s potential to develop multivalent vaccines that could improve an exponential number of patient lives.
The Maveropepimut-S (MVP-S) vaccine
Another notable cancer vaccine in BioVaxys’ portfolio is Maveropepimut-S (MVP-S), which delivers antigenic peptides from the survivin family – most common in advanced cancers – complemented by an innate immune activator and a universal T Cell helper peptide that guides cytotoxic or killer T Cells towards infected cells. The vaccine is rapidly accumulating evidence in support of its tolerability and benefits against multiple cancers, as evidenced by:
- Phase 2B clinical development for platinum-resistant ovarian cancer, yielding a 21 per cent overall response rate, a 63 per cent disease control rate and a clinical benefit of more than 6 months for 36.8 per cent or 7 of 19 subjects studied, positioning the company to potentially add value in a more than US$4 billion market.
- Phase 1 development in a combination treatment with Merck’s Keytruda for Advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL), as well as bladder, lung, liver and ovarian cancer, yielding a complete responses in 3 of 6 evaluable DLBCL patients, with no cancer detectable after treatment, adding exposure to another more than US$4 billion market.
- Phase 1 development as an adjuvant hormone therapy alongside Letrozole to treat HR(+) / HER2(-) stage II-III breast cancer, representing a more than US$26 billion market, generating a substantial immune response in all three study participants.
BioVaxys has initiated MVP-S out-licensing for ovarian cancer and DLBCL indications, with bladder cancer on track to be added to the list for both MVP-S and DPX+SurMAGE based on new results from an ongoing clinical study.
A new hope for non-muscle invasive bladder cancer patients
Results from the phase-1 study in question, evaluating MVP-S and DPX+SurMAGE’s safety and immunogenicity in NMIBC patients, build an early-stage case for BioVaxys meeting the shortfall left by BCG immunotherapy.
The two-arm study tested MVP-S alone on 9 patients in Arm A, targeting antigens from the survivin family, and DPX-SurMAGE alone on 3 patients in Arm B, targeting survivin and MAGE-A9 antigens, with both vaccines proving to be well tolerated, while producing powerful antigen-specific T Cell responses at day 0, 28, 49 and 109 using IFN EliSpot analysis, a method capable of detecting and counting individual T Cells.
Highlight data points include 55 per cent of participants in the MVP-S arm showing significant responses peaking on day 28, and 33 per cent in the DPX-SurMAGE arm peaking on day 49, with numerous patients remaining cancer-free after an average follow-up of two years, demonstrating efficacy and duration that leads study leader, Dr. Yves Fradet, MD, professor of urology and surgery and Researcher at the Centre de Recherche du CHU at Université Laval in Quebec, to believe that these vaccines “could represent an attractive new treatment for NMIBC patients who failed BCG … that warrants further investigation in a phase-2 trial.”
BioVaxys has put itself in a position to continue this development, benefitting from patented assets, C$1.92 million raised in November and a leadership team with more than 50 years of drug development and capital markets experience, thoroughly equipping the company to create value by progressing along the clinical trial lifecycle. Key team members include:
- Chief executive officer (CEO), James Passin, who brings more than 20 years of experience as a professional investor, with a focus on financing, business development and early-stage companies, as well as managing substantial biotech equity and debt investments.
- President and chief operating officer, Kenneth Covan, whose more than 30 years in commercial development with GlaxoSmithKline (now GSK), Thomas Jefferson University, Wyeth Pharma and Horizon Discovery, has afforded him ample applicable therapeutic experience in viral vaccines, oncology, cancer vaccines, antivirals and infectious diseases. Covan is the founder and former CEO of AVAX Technologies.
- Chief medical officer (CMO), Dr. David Berd, a clinical oncologist specializing in cancer immunotherapy research currently serving as national director for immunotherapy at Cancer Treatment Centers of America, professor of medicine at Thomas Jefferson University and research physician at Fox Chase Cancer Center. Berd, a founder and former CMO at AVAX Technologies, is the inventor of the MVax and OVax cancer vaccines.
With numerous multi-billion-dollar addressable markets within oncology alone, a pair of vaccines showing early promise for meeting unmet patient needs, and a leadership team that knows how to fund and bring oncological innovations to market to tie its value proposition together, BioVaxys already offers investors solid evidence in support of a highly-dislocated contrarian play, but this tells only a fraction of the company’s multi-pronged growth story.
DPX’s diversified immunotherapy pipeline
BioVaxys’ DPX platform has expanded its development pipeline well beyond cancer, leading to the creation and ongoing advancement of vaccines focused on antigen desensitization for food allergy, such as DPX+rPA for peanut allergy prophylaxis, as well as infectious diseases, including DPX -rPa for anthrax, DPX-rHA/DPX-FLU for influenza and DPX-RSV for Respiratory Syncytial Virus, the latter demonstrating antigen-specific immune responses in 93 per cent of phase-1 subjects, with 100 per cent of responders in the 25μg dose cohort maintaining immunity one year after treatment, prompting the company to initiate out-licensing efforts.
Collectively, these wide-ranging candidates hold the potential to grow BioVaxys’ addressable market exponentially and significantly widen the gap between market cap and intrinsic value, supported by the aforementioned financing, the flexibility of only 29.3 million shares outstanding, in addition to DPX-related animal health partnerships (see slide 14) expected to deliver royalty revenue as soon as this year.
Under this prospective light, we’re able to look past the pessimism of BioVaxys stock’s more than 60 per cent loss since securing IMV’s assets, revealing recent price action to be a robust example of market inefficiency, one where any micro-cap investor with a sense for value and a gap in the healthcare sleeve of their portfolio should be champing at the bit to put the company through due diligence before revenue growth and positive news flow trigger a re-rating.
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