As every biotech investors know, the FDA’s drug approval process is rigorous, time-consuming and expensive. In order to advance through the multiple clinical trials to obtain approval of their life-saving treatments, companies in the space need to be well prepared on a variety of fronts. Among the most critical areas are leveraging high degrees of scientific and medical expertise, as well as a sound financial position to fund the ongoing studies. This is especially true for a company like Immunovaccine Inc. (IMV:CA)(IMMVF), whose versatile DepoVax™ platform has shown the potential for many applications and combination treatments in the fight against cancer. With the recently announced $10 million financing, through a bought deal offering, the company is as firmly positioned as ever from a capitalization perspective to bring its transformational cancer therapies to market.

From a scientific pedigree standpoint, the company’s recent formation of an inaugural Scientific and Clinical Advisory Committee (SCAC), which “will provide counsel for Immunovaccine’s research and development activities and access to cutting-edge ideas through collaborative data sharing and insight” provides an entirely new dynamic for the company’s trajectory. The Committee is comprised of distinguished industry professionals in the areas of Immunovaccine’s targeted diseases: immuno-oncology and virology.

DepoVax is a game-changer because of its capacity to deliver numerous types of therapeutics to cancerous cells, providing a focused and protracted immune response that can be successful with a single dose. Currently, Immunovaccine has three triple-combination studies in progress using DPX-Survivac with low-dose cyclophosphamide and other immuno-modulating agents. This new financing agreement will allow the company to continue to research and investigate how the DepoVax platform can work synergistically with other therapies, which some believe is the key to truly winning the war against cancer and finding cures.

Immunovaccine’s DepoVax represents a new foundation in immuno-oncology where patients can see long-lasting regression and even prevention. Scientific evidence continues to mount that DepoVax’s distinct approach makes it an enabling agent of choice for combination treatment.

Shifting the Paradigm in Fighting Hard-to-Treat Cancers

Partnerships and scientific collaborations have been vital for Immunovaccine because they have spawned breakthroughs and highlighted the adaptability of the proprietary platform. As the word has spread about DepoVax over the years, one combination study has led to another. These research partnerships and investigator-sponsored clinical trials speed up the process for those who are truly fighting for their lives against a disease with no cure.

In that vein, Immunovaccine announced a new Phase II clinical trial for a triple combination study against an aggressive form of non-Hodgkin lymphoma (NHL), large B-Cell lymphoma (DLBCL). This Phase II clinical trial comes on the heels of a Phase II clinical study where one patient experienced changes in tumor-infiltrating T cells, which correlated with an immune response produced by DPX-Survivac and detected in the blood. This promising data exemplifies the potential of Immunovaccine’s platform and how it could shift the paradigm in how we tackle difficult-to-treat cancers.

“While immunotherapies, such as checkpoint inhibitors, are rapidly changing the standard of care in many cancers, it has been reported that only about 20 percent of patients are able to respond to these therapies alone, leaving the vast majority of patients with a significant unmet medical need,” said Frederic Ors, Chief Executive Officer at ImmunoVaccine. “Our clinical strategy builds on our earlier research, which indicated that novel combination immunotherapies – particularly those with the ability to increase T-cell tumor infiltration – may work together synergistically to increase the number of patients responding to today’s advanced treatments. We remain committed to working with world-class partners to bring these combinations through clinical development. Our goal is to generate more therapeutic options for patients currently underserved in today’s treatment landscape.”

In addition to the above DLBCL trial, DPX-Survivac currently is being tested in another Phase II trial for DLBCL at the Ottawa Hospital Research Institute and the Odette-Sunnybrook Cancer Centre. About 40% of non-Hodgkin lymphoma cases are eventually diagnosed as DLBCL, so these two trials represent significant hope for many patients out there.

DepoVax: A Versatile and Scalable Platform

Many of the advancements and exciting results center around the patented platform Immunovaccine has created. DepoVax currently has been used in partnerships to treat infectious diseases, bio-terrorism, addiction medicine and animal health. Immunovaccine holds the patent on the oil-based formulation, which encompasses a very broad patent portfolio, making it extremely scalable.

DepoVax is one-of-a-kind because its delivery system is not water-based, unlike many competitors, and does not wash away. This holds the adjuvants and antigens to the injected area forcing T-cells to come and attack the target area.

“Our DepoVax™ system gives us a broad foundation to develop novel therapeutics in both infectious disease and cancer,” Ors told Equities last year. It can be used to safely extend exposure of the immune system to practically any antigen and adjuvant; has reliably demonstrated a tolerable safety profile and sustained relevant immune responses in several clinical trials; and can be readily combined with other vaccine development approaches.”

Furthermore, Immunovaccine is developing DPX-Survivac, also using the core DepoVax platform, to treat ovarian cancer. A Phase 1b study, a triple combination study with Incyte (INCY), of DPX-Survivac in combination with Epacadostat and low-dose cyclophosphamide is showing positive results at the Princess Margaret Cancer Centre. Immunovaccine also has a second Phase 2 study at the Princess Margret Cancer Centre that is a combination therapy study funded by Merck (MRK) enrolling 42 subjects with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. In addition, DPX-E7, another formulation of the DepoVax platform, is in a Phase 1b/2 clinical study at the prestigious Dana-Farber Cancer Institute through a $1.5 million research grant from Stand Up to Cancer and the Farrah Fawcett Foundation to develop therapies for high-risk HPV-related cancers.

DepoVax has proven uniquely successful in its ability to activate T-Cells and to sustain an immune response, while also protecting the patient from high toxicity levels. These facts alone make it extremely desirable as a delivery system for new therapy candidates and combination therapies. The company’s new $10 million bought deal gives it the essential capital to keep testing this groundbreaking platform and to keep working to find cures to save lives.


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