BioVaxys' Bargain Bonanza: Seizing a Biotech Treasure Trove from IMV's Ashes

The Players

BioVaxys Technology Corp. (CSE:BIOV) landed a major coup by acquiring the extensive intellectual property, Immunotherapeutics platform technology, and clinical-stage assets of the former IMV Inc. At one time, IMV was a promising Nova Scotia based biopharma company that had a US$300 million market cap. However, a combination of the biotech sector downturn, secured debt, and capital-intensive spending by company management ultimately led to the company’s bankruptcy last year.

In its 14 years as a publicly listed company, it is estimated that IMV spent more than US$250 million in research & development in order to develop its extensive set of clinical-stage assets. IMV’s misfortune created an opportunity for BioVaxys to swoop in and acquire the company’s IP portfolio at pennies on the dollar. As the saying goes, one man’s trash is another man’s treasure. BioVaxys is now moving full-steam ahead to prove that it has just acquired a treasure trove of biopharma data and intellectual property.

The BIOV opportunity is to seize upon the rapidly growing global cancer immunotherapy market - it is anticipated that the global cancer immunotherapy market will reach a valuation of US$217.9 billion by 2030, up from $122.3 billion in 2023 and representing a compound annual growth rate of 8.6% during the forecast period.

The Transaction

The BIOV/IMV acquisition includes the DPX™ platform and over 100 international filings related to various immune system-related diseases, trademarks, and a royalty-bearing license with several companies for the development and sale of various health products using the acquired technology. This move significantly enhances BioVaxys' strategic position in cancer immunotherapy and expands its pipeline to include treatments for ovarian, bladder, and breast cancer, among others​.

The transaction supplements BioVaxys’ existing cancer vaccine portfolio with the addition of maveropepimut-S (MVP-S), a DPX™-formulated cancer vaccine that delivers antigenic peptides from survivin, a cancer antigen commonly overexpressed in advanced cancers. Survivins are highly expressed in most cancers and are associated with a poor clinical outcome, with the differential expression of survivin in cancer cells compared to normal tissues and its role as a nodal protein in a number of cellular pathways make it a significant target for cancer therapeutics.

MVP-S also delivers an innate immune activator and a universal CD4+ T cell helper peptide. These elements foster maturation of antigen presenting cells as well as robust activation of CD8+ T cell effector and memory function. Maveropepimut-S was recently in Phase IIb clinical trials for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and is being clinically evaluated in bladder and breast cancer. In prior clinical studies, MVP-S treatment has been well tolerated and has demonstrated favorable clinical outcomes in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. Most recently, data were presented by IMV at the 2023 SGO Annual Meeting on Women’s Cancer on a Phase Ib/II multicenter trial designed to evaluate MVP-S combined with intermittent low dose of cyclophosphamide in patients with recurrent, epithelial ovarian, fallopian tube, or peritoneal cancer. Findings showed clinical benefit to patients with recurrent ovarian cancer, regardless of platinum sensitivity or BRCA mutational status

Through the transaction, BioVaxys has acquired 25 distinct families of patents and/or patent applications, with over one hundred related international filings related to maveropepimut-S, DPX™, and their use across a range of immune system-related diseases, as well as associated trademarks and other intellectual property. The deal also assigns to Biovaxys a royalty-bearing License and Supply Agreement with Wisconsin-based SpayVac for Wildlife Inc.,on sales of animal vaccine products using technology acquired from IMV by BioVaxys, a milestone payments and royalty bearing license agreement with Pfizer animal health spin-out, Zoetis Inc, the world’s largest producer of medicine and vaccinations for pets and livestock, for their development and sale of various animal health products using the technology acquired by BioVaxys, and German pharmaceuticals company MERCK KGaA for survivin proteins.

The DPX^TM Technology

The DPX™ antigen delivery platform acquired by BioVaxys is designed to stimulate a specific, coordinated and persistent anti-tumor immune response, improving the lives of patients with solid or hematological cancers. DPX™ can package a wide range of bioactive molecules in a single formulation, such as such as multiple nucleic acids/mRNA, proteins, peptides, virus-like particles, innate immune activators, and small molecules, to “feed” them to Dendritic Cells and Antigen Presenting Cells (or “APC’s”) to stimulate a specific immune response.

The DPX™ platform is a proprietary delivery technology designed for immunotherapy applications, particularly in the treatment of hard-to-treat cancers and other diseases where a targeted immune response is desirable. This platform is known for its ability to generate a robust, sustained T-cell response, which is crucial for fighting cancer. The technology is versatile and has been applied in various therapeutic areas, showing potential to significantly mitigate disease through the generation of target-specific immune responses​​.

Key highlights of the DPX™ platform include:

• The platform's unique mechanism of action involves delivering cancer-specific targets directly to antigen-presenting cells, which then prime the immune system to attack and destroy cancer cells​​.
• BioVaxy's lead candidate developed using the DPX™ platform, maveropepimut-S (formerly DPX-Survivac), targets survivin, a protein overexpressed in many types of cancer. This therapy has shown promise in inducing durable immune responses in advanced ovarian cancer and is being explored in breast cancer and other malignancies in combination with other therapies​​​​.
• Another notable immunotherapy developed with the DPX™ platform is DPX-SurMAGE™, targeting survivin and MAGE-A9, two antigens associated with poor prognosis in bladder cancer. Preclinical studies have demonstrated its potential for inducing targeted T-cell responses, supporting its progression to clinical trials​​.
• The DPX™ platform's flexibility is highlighted by its ability to work with a wide range of cancer-fighting agents, from proteins and antigens to RNAs, suggesting its potential to revive molecules that showed promise in preclinical models but failed in early human trials​​.

In terms of clinical outcomes, the DPX™ platform has been linked to impressive results in various studies:

• For ovarian cancer, treatments developed using the DPX platform have led to sustained CD8+ T-cells targeting survivin, showing significant potential in treating recurrent ovarian cancer resistant to platinum-based therapies​​.
• The platform's potential for combination therapies has been explored, particularly in combining DPX-Survivac™ with pembrolizumab (Keytruda), a checkpoint inhibitor. This combination aims to enhance the immune response against cancer by targeting both the survivin protein and PD-L1/PD-1 pathways, which are crucial for immune evasion by cancer cells​​.

DPX™ formulations are not limited to cancer immunotherapies. With its unique cargo carrying capacity and non-circulating lipid delivery, there is potential with DPX™ to develop improved mRNA vaccines, multivalent viral vaccines, vaccines for desensitizing immune response for peanut allergies, and immune system diseases. Prior clinical studies by IMV have supported proof of concept and a superior immune response with a DPX-RSV formulation, DPX™-rHA/DPX-FLU influenza vaccine, DPX™-packaged survivin/MAGE-Ag for advanced metastatic bladder cancer, and certain other infectious diseases.

BIOV is actively exploring the application of the DPX™ platform beyond oncology, indicating its potential in developing treatments for infectious diseases and other conditions, thereby underscoring the technology's versatility and wide-ranging therapeutic potential​​.

Overall, the DPX™ platform represents a significant advancement in the field of immunotherapy, with ongoing research and clinical trials aimed at fully realizing its potential across a broad spectrum of diseases.

Disclosure

BioVaxys is a sponsor of MedicalGold.ca, read full disclaimer here: https://www.medicalgold.ca/sponsorships.