Halifax-based Immunovaccine Inc., a clinical-stage immuno-oncology company, has announced that its main drug candidate for battling cancer will go through a Phase 2 clinical trial.
The publicly listed company said this week that its DPX-Survivac cancer vaccine candidate and a product of the New Jersey-based pharma giant Merck will be the subject of a Phase 2 trial at the Princess Margaret Cancer Centre in Toronto. Researchers aim to test the safety and efficacy of the drug combination on 42 ovarian cancer patients. Immunovaccine, or IMV, said in a statement that Merck will pay for the trial, which will begin once they receive regulatory clearance from Health Canada.
Immunovaccine has developed a platform for delivering drugs called DepoVax, which allows a constant flow over a long period of time of drugs that work with the immune system to battle diseases. The product being tested in this trial, DPX-Survivac, operates in the DepoVax platform. The drug being provided by Merck is a checkpoint inhibitor called Pembrolizumab.
"Ovarian cancer is a main focus for Immunovaccine as we continue to develop DPX-Survivac," said Immunovaccine CEO Frederic Ors in a statement. "Combination therapies … are emerging as increasingly promising approaches for hard-to-treat cancers.” He added that he hoped the trial, if successful, would “position our immuno-oncology candidate as an optimal co-therapy in this disease area."
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Phase 2 trials are a big deal, and it's extremely rare for an Atlantic Canadian drug discovery company to reach this phase of clinical trials. Phase 2 trials test for efficacy, meaning they prove a drug does what the company says it can do, and the costs usually amount to tens of millions of dollars.
The trial at the Prince Margaret will test the anti-tumor activity of the IMV and Merck products along with low-dose cyclophosphamide, a medication used in chemotherapy.
The study's primary objective is to assess the overall response rate, which means it will examine whether the combination of drugs actually shrinks cancer tumors. The secondary objectives include the study of the progression-free survival rate, overall survival rate, and potential side effects, over a five-year period.
"Ovarian cancer is among the most challenging cancers to treat, as it is associated with poor response rates to currently available medical interventions," said Amit M. Oza, the Senior Staff Physician at Princess Margaret who will be lead investigator in the trial. "To support the tens of thousands of women battling this disease, we need to develop new and novel approaches. With this trial, we have the opportunity to explore a novel combination of promising immunotherapies."
The company has conducted previous clinical trials on DPX-Survivac combined with a low dose of cyclophosphamide. These showed the combination was “highly immunogenic” in most participants with high-risk ovarian cancer.
IMV also announced it is conducting a Phase 1b trial with Incyte Corp. to evaluate the triple combination of DPX-Survivac with one of Incyte's drugs called Epacadostat, and low-dose oral cyclophosphamide in patients with platinum sensitive or resistant ovarian cancer. Immunovaccine expects to announce top-line interim results for this trial by the end of March.
Immunovaccine, which is listed on the Toronto Stock Exchange and has a market capitalization of $118 million, raised $8 million in December through a private placement of shares.
Disclaimer: the author owns Immunovaccine shares.
