Deciphera Pharmaceuticals is stopping work on two programs, focusing its research efforts on two others, and cutting its headcount by 35% in a corporate restructuring. The moves announced Tuesday come weeks after clinical trial data hoped to support expanded use of its sole commercialized product fell short of expectations, dashing the prospects of that drug becoming a blockbuster seller.
The commercialized cancer drug, Qinlock, will still be supported by Waltham, Massachusetts-based Deciphera. But the company will streamline its U.S. sales force and focus commercialization of the gastrointestinal stromal tumor (GIST) treatment in select markets in Europe.
Deciphera’s drug are part of a class of medicines called kinase inhibitors. The company’s technology designs compounds that interact with regions of a kinase that regulate the enzyme’s switch function, turning it on or off. Last year, Qinlock became the first Deciphera switch-control drug to win FDA approval, a decision that covers GIST patients whose disease has not responded to three earlier lines of therapy. European approval of Qinlock last week also covers use of the drug as a fourth-line treatment.
Deciphera had been seeking to expand Qinlock’s U.S. approval to permit its use as a second-line treatment, which would open up a larger market. The biotech ran a Phase 3 study to produce the data that could support the expansion. On Nov. 5, Deciphera reported preliminary results that showed Qinlock did not meet the main goal of beating the standard of care therapy, sunitinib, in helping patients live longer without the cancer getting any worse.
On Tuesday, Deciphera said it is discontinuing further clinical development of Qinlock. The company is also stopping work on rebastinib, a drug that was slated to enter Phase 3 testing in ovarian cancer next year. The company said its focus is now on developing drugs that could be the first or the best in their therapeutic classes. To that end, the company is devoting its research resources to two earlier-stage programs, vimseltinib and DCC-3116.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Vimseltinib, a drug designed to block the kinase CSF1R, is on track to begin a Phase 3 study by the end of this year. Deciphera is developing the drug as a treatment for tenosynovial giant cell tumor, a group of rare, benign tumors affecting joint tissues. Surgery is the main treatment option, but these tumors can recur. Meanwhile, DCC-3116 is designed to block a kinase called ULK. Deciphera is developing that drug to address cancers in which autophagy, the process for disposing of damaged cellular components, is upregulated, which the company said is believed to play an important role in tumor growth and survival. Deciphera said a Phase 1/2 study of DCC-3116 is on track to evaluate the drug’s ability to inhibit autophagy in cancer.
In the nine months ending Sept. 30, Deciphera reported that Qinlock accounted for $59.9 million in revenue. The third quarter financial report showed a cash position of $392 million. With the restructuring, the company said its cash should be enough to last into 2024. The restructuring will cut about 140 jobs, including employees involved in Qinlock’s commercialization, research and development, and other parts of the company. Deciphera will take a one-time $32 million cash charge in the current quarter, which breaks down to $10 million in employee-related termination costs and $22 million in contract termination fees and other financial commitments associated with the discontinued drug programs, according to a regulatory filing.
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