Oncolytics Bio Tacks On Cancer Combo Study with Merck KGaA, Pfizer

Xconomy San Diego — 

There’s a speed dating game of sorts happening as pharmaceutical companies that have approved cancer immunotherapies are testing their medications in combination with experimental drugs in hopes of reaching more patients.

San Diego’s Oncolytics Biotech (NASDAQ: ONCY) has been an active participant in those combination efforts, with multiple pharmaceutical companies pairing its lead drug candidate, an oncolytic virus—which can infect and kill tumor cells, according to the National Cancer Institute—called pelareorep, in tests with the drug developers’ treatments. Cancer immunotherapies have shown to be effective as a treatment for some cancers, but only in a fraction of patients.

Oncolytics, which was founded in Canada in 1998 with technology licensed from the University of Calgary and opened its San Diego office in 2017, inked another such deal this month, this one with Germany’s Merck KGaA and Pfizer (NYSE: PFE). (Merck KGaA isn’t to be confused with Kenilworth, NJ-based Merck.)

The agreement calls for the companies to conduct a Phase 2 trial testing pelareorep in combination with avelumab (Bavencio), an immunotherapy that Merck KGaA and Pfizer jointly developed. They’ll test that combination with paclitaxel, a chemotherapy used to treat a subtype of breast cancer that has spread.

Oncolytics and Pfizer will share the cost. The biotech says pelareorep is designed to both kill cancer cells and—like other immuno-oncology therapies—activate the body’s immune system against cancer.

Avelumab is a type of cancer immunotherapy called a checkpoint inhibitor that shuts down a mechanism tumors use to hide from the immune system. The drug, which the FDA approved in 2017 to treat bladder cancer and Merkel cell carcinoma, a rare type of skin cancer, targets a protein called PD-L1 that some cancer cells use to avoid detection by T cells as foreign. In addition to testing it in breast cancer, the companies are also studying avelumab as a therapy for other types of cancer.

Further tests of avelumab have yet to provide data strong enough to support expansion of its approval to additional cancers. In a stomach cancer clinical trial in 2017, it failed to beat chemotherapy.

The upcoming Phase 2 trial that Oncolytics will conduct under its latest partnership will enroll 45 patients with hormone-receptor positive, human epidermal growth factor 2-negative (HR+ / HER2-) breast cancer, a common and slow progressing form of the condition, according to the American Cancer Society. One-third of patients will receive only chemotherapy; another third will get the chemo drug and pelareorep; the final third will get the chemo, pelareorep, and avelumab.

As Xconomy reported in May, while checkpoint inhibitors have begun to transform some areas of cancer care, breast cancer isn’t yet among them. Among the difficulties in treating the disease is that it manifests in various subtypes. It also tends to express less PD-L1 than other cancers.

The National Institutes of Health estimates that 268,600 women in the US will be diagnosed with breast cancer this year, and that about 41,760 people will die of the disease. While the five-year survival rate for women diagnosed with the disease is 90 percent, for women with breast cancer that has spread, the average is 27 percent, according to statistics from the American Society of Clinical Oncology.

As in speed dating, Oncolytics’s latest partnership isn’t an exclusive one. But the company, which has been dating around a good bit, foresees a future of monogamy when it comes to treating breast cancer as early as next year. … Next Page »

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