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an injectable chemotherapy drug that the FDA approved for use alongside gemcitabine, the standard of care. Last year, Cambridge, MA-based Merrimack Pharmaceuticals received FDA approval for its pancreatic cancer drug, an injectable nanotherapy. This irinotecan liposome injection (Onivyde) is derived from the old chemotherapy drug irinotecan. Merrimack developed this compound to target tumors more specifically, and for a longer time, than conventional chemotherapies.
But several pancreatic cancer drug efforts have fizzled. In May, Berkeley, CA-based Aduro Biotech failed in clinical trials with a drug that combined two immunotherapies. OncoMed Pharmaceuticals, a drug developer based in Redwood City, CA, has three compounds in clinical trials for different cancers, including pancreatic cancer. One of them, tarextumab, stumbled at the beginning of the year when an interim look at a mid-stage trial studying the compound in pancreatic cancer found “low probability” that it would extend the life of patients. Two other OncoMed compounds being studied in pancreatic cancer are still in the early stages of clinical development.
Apexian’s drug could offer some advantages compared to other pancreatic cancer treatments, Carchedi says. Unlike many cancer drugs that are injectable, APX3330 is a pill. The Apexian drug is also selective; it only targets APE1/Ref-1, a protein that Carchedi says is not needed by healthy cells. He points to Eisai’s 10 clinical trials testing 422 patients, which showed that the compound was safe and produced no side effects. While that sounds promising, Apexian still needs to demonstrate that safety in cancer patients. The FDA has given the green light for Apexian to proceed with a Phase 1 clinical trial in pancreatic cancer expected to enroll between 20 and 40 patients.
Carchedi is now charged with raising money and laying the groundwork for pharma partnerships. He came to Apexian in October from Cornerstone Pharmaceuticals, a Cranbury, NJ-based company he led as CEO for two years. His cancer drug experience also includes posts at Mallinckrodt Pharmaceuticals, as well as Johnson & Johnson (NYSE: JNJ), where he was the global marketing leader for that company’s oncology division. At Eli Lilly, Carchedi was director of the oncology product group.
Apexian aims to raise $10 million from outside investors to support its clinical research. Since inception, ApeX Therapeutics had raised more than $3.5 million from investors, according to securities filings. Angel investors and IU’s Innovate Indiana Fund supported the company early on before it secured venture capital investment from BioCrossroads and Pearl Street Venture Funds, both based in Indianapolis. While Apexian pursues additional investors in the near term, Carchedi says the company will eventually seek out larger pharmas as partners. Apexian’s drug might work best alongside other cancer treatments, such as immunotherapies. Partnerships could offer a way to test such combinations, he explains.
Though pancreatic cancer is Apexian’s first target, Carchedi says the company’s lead compound could have broader applications. In animal studies, APX3330 stopped cancer growth in 13 cancers including breast, prostate, renal, head and neck, and colorectal cancers—all cancers dependent on the APE1/Ref-1 protein, Carchedi says. Apexian also has two additional compounds in its drug pipeline. But first, the company needs to prove that its approach to its targeted protein pathway works. Carchedi expects Apexian will begin enrolling patients in the pancreatic cancer clinical trial early next year.
Image of pancreatic cancer cells courtesy of the National Cancer Institute.