​Immunovaccine's Combination Studies are Leading to Breakthroughs

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Diffuse Large B-cell Lymphoma (DLBCL) is the most common lymphoma subtype, accounting for around 30% of newly diagnosed cases of Non-Hodgkin Lymphomas, and known for its ability to aggressively spread. Furthermore, the onset of DLBCL can arise through a painless swelling of the neck or underarms. As symptoms can be slight combined with the fast-moving nature of the lymphoma, immediate treatment is imperative. While there are current treatment options, often times patients see no progress or remission. So, there is significant anticipation surrounding the work being done by Immunovaccine, Inc. (IMV:CA)(IMMVF), recently announced that they are recruiting patients for a Phase 2 clinical study of their triple combination immunotherapy for DLBCL.

Health Canada has granted clearance to Toronto’s Sunnybrook Research Institute, one of the most respected research centers in Canada, to start gathering patient to test Immunovaccine’s revolutionary DPX-Survivac along with Merck’s (MRK) Pembrolizumab and low-dose cyclophosphamide.

“With clearance received from Health Canada, we hope to quickly begin the important work of evaluating a critically needed therapy for those who suffer from DLBCL – a fast-growing form of lymphoma that can spread to nearly every organ of the body,” said Frederic Ors, Chief Executive Officer at Immunovaccine. “Despite promising results observed in the treatment of DLBCL with cutting-edge monotherapies like checkpoint inhibitors, a significant number of patients still do not respond to treatment. It is our goal to increase the types of patients who are able to respond to these therapies via synergistic combinations that can activate and direct T cell responses. Through complementary mechanisms of action, we believe the combination of DPX-Survivac and pembrolizumab could amplify T cell production and infiltration to help realize the desired immune response in a broader range of patients with this type of cancer.”

Working Alongside Big Pharma

Immunovaccine’s combination therapy study is extremely exciting because of the collaboration with Merck. Merck’s pembrolizumab, a checkpoint inhibitor, is slowly becoming the go-to option in the sector over Bristol-Meyers Squibb's Opdivo. Keytruda, the name of Merck’s immunotherapy drug that targets the programmed cell death 1 receptor (PD-1), is having a banner year. Merck’s sales for Keytruda have tripled to $1.05 billion. Already, Keytruda has been approved for advanced melanoma, advanced non-small cell lung cancer, hodgkin’s lymphoma, and head and neck squamous cell cancer. For lung cancer, in particular, the drug is expanding in first-line therapy.

Couple this successful immunotherapy with DPX-Survivac, a T-cell activating immunotherapy that uses Immunovaccine's versatile DepoVax formulation to target survivin, a cancer stem cell antigen and biomarker of cancer progression. DPX-Survivac received Fast Track Designation from the FDA for patients with advanced Ovarian Cancer and all told represents a revolution in the treatment landscape because of the potential for more precise cancer treatments that employ the fighting power of a patient's own immune system. The DepoVax platform is really the catalyst for breaking the mold in oncology by focusing on the sustained and powerful delivery of immunotherapies all the while protecting patients from high toxicity levels. According to Immunovaccine’s website, “how we deliver instructions to the human immune system is the key to generating a pivotal, sustained response against diseases previously unresponsive to immunotherapies.”

DepoVax is unique 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. Moreover, Immunovaccine achieves this "no release" response by taking novel antigen candidates, formulating them within liposomes (tiny bubbles comprised of cell material), freeze drying the formulation to remove all the water content to ensure stability and suspending a drug candidate before reconstitution in an oil formulation for delivery.

"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."



The Next Steps for Immunovaccine

It is important to note, this research trial at Sunnybrook will be the third ongoing trial using DPX-Survivac with low-dose cyclophosphamide and other immuno-modulating agents. The Company announced earlier this year that an investigator-sponsored Phase 2 study will evaluate the anti-tumor activity of Merck's pembrolizumab with DPX-Survivac and cyclophosphamide in patients with recurrent, platinum-resistant ovarian cancer. In addition, Immunovaccine recently released positive early data from its Phase 1b triple-combination trial with Incyte Corporation, evaluating DPX-Survivac, low-dose cyclophosphamide and Incyte's IDO1 inhibitor epacadostat in patients with recurrent ovarian cancer.

This recent triple combination to fight DLBCL comes from a deep analysis on one patient after early Immunovaccine's initial Phase Two study. The said patient saw changes in tumor-infiltrating T-cells correlated to an immune response boosted by DPX-Survivac.

In short, it has been an exciting year for Immunovaccine. This summer, the company had a major milestone occur when their DPX-NEO program, a collaboration with UConn Health, successfully formulated 14 neoepitope cancer peptides into one single DepoVax formulation. Neoepitopes independently are revered for their potential because they function as unique tumor-specific antigens that the adaptive immune system uses to selectively target tumors without collateral damage to healthy cells. In lab studies, Immunovaccine’s new combination cancer vaccine demonstrated the ability to generate specific killer T-cell responses against cancer peptides.

However, the real breakthrough is in the flexibility to target a broader range of immunogenic candidates.

“Developing a suitably immunogenic delivery system that can accommodate multiple potential targets is one of the most significant challenges faced by this type of therapy, and while we are thrilled to have found a potential solution to this limitation, we believe that the implications of this formulation process can go well beyond the neoepitope space,” said Marianne Stanford, Vice President, Research, at Immunovaccine during the company press release.. “We see future applications of the DepoVax multiple peptide formulation using a high number of tumor-associated antigens in one immuno-oncology agent, or multiple targets for an infectious disease within one vaccine. We are excited to explore the potential applications of this technology.”

Next for the company, Immunovaccine's scientific team will be presenting data on the broad utility of the DepoVax technology at the 2017 Society for Immunotherapy of Cancer (SITC) annual meeting this month.

In this Moonshot environment, collaborations have been vital for Immunovaccine because they have led to breakthroughs and highlighted the adaptability of the proprietary platform. These research partnerships and clinical trials - like the triple combination to fight the ultra-aggressive DLBCL - accelerate the process for those who are truly fighting for their lives against a disease with no cure.

"We remain committed to working with world-class partners to bring these combinations through clinical development," Ors said in a previous interview. "Our goal is to generate more therapeutic options for patients currently underserved in today's treatment landscape."

This trial and working alongside Merck could mean big things ahead for Immunovaccine and those looking for a life-saving treatment.


*Correction: The article has been updated to reflect the correct rate of DLBCL in the United States. B-cell lymphomas account for approximately 85% of all NHLs, whereas DLBCL accounts for about 30% of newly diagnosed cases of NHL.

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Companies

Symbol Name Price Change % Volume
IMMVF ImmunoVaccine Inc. 1.25 -0.02 -1.73 3,927
IMV:CA Immunovaccine Inc. 1.59 0.02 1.27 110,925

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