Deciphera Pharmaceuticals announced it is restructuring with the intention of prioritizing clinical development of specific programs and streamlining its commercial operations.
Deciphera Pharmaceuticals, based in Waltham, Mass., announced it is restructuring with the intention of prioritizing clinical development of specific programs and streamlining its commercial operations. In addition to cutting one of its programs, it plans to reduce about 35% of its staff, or about 140 positions. The company believes these actions can extend their cash runway into 2024.
“The decision to realign our resources and restructure our organization was difficult, but one which will allow us to focus on the critical programs that will drive our future growth,” said Steve Hoerter, president and chief executive officer of Deciphera. “I would like to personally express my appreciation to our colleagues who are impacted by this decision. We are immensely grateful for their dedication and their contributions to advancing our mission.”
It plans to continue advancing vimseltinib and DCC-3116 and discontinue rebastinib. Vimseltinib is an oral, potent and highly selective switch-control kinase inhibitor of CSF1R. It is being evaluated for tenosynovial giant cell tumors (TGCT). DCC-3116 is an oral, potent and highly selective switch-control inhibitor of the ULK kinase, designed to inhibit autophagy, a tumor survival mechanism. It believes that in combination with RAS/MAP kinase signaling pathway inhibition it has the potential to treat RAS/RAF cancers.
Rebastinib was expected to begin a Phase III trial in patients with platinum-resistant ovarian cancer in 2022. They are discontinuing that program.
The company also indicated they are streamlining their commercial activities related to Qinlock (ripretinib) for fourth-line gastrointestinal stromal tumors (GIST) in the U.S. It will decrease its commercial team in the U.S., while in Europe will maintain a limited direct commercial presence to support the drug’s launch in Germany and France. It plans to provide access to the drug in other European countries via other channels. It also reported it will discontinue further clinical development of the drug, including the planned Phase Ib/II MEK combination study that was expected to start in the fourth quarter of this year.
“We remain excited by the strength of our pipeline and the opportunity for Qinlock to continue to benefit patients with advanced GIST. We have a clear and positive path forward with a committed team that is fully invested in the future of Deciphera,” Hoerter stated.
On November 22, the European Commission approved Qinlock in the European Union for adults with advanced GIST who had received previous treatment with three or more kinase inhibitors, including imatinib. In September 2021, it was added as a fourth-line treatment for GIST patients progressing or intolerant to imatinib, sunitinib, and regorafenib to the ESMO-EURACAN-GENTURIS clinical practice guidelines for GIST.
At the time, Jean-Yves Blay, professor of Medicine at the Universite Claude Benard in Lyon, France, said, “With a complex disease like advanced GIST, the availability of new efficacious and tolerable treatment options is critical for patients. The treatment of advanced GIST patients who initially respond to traditional tyrosine kinase inhibitors but eventually develop tumor progression due to secondary mutations has remained an area of high unmet medical need in Europe. In the INVICTUS study, Qinlock demonstrated compelling clinical benefit in progression-free and overall survival and was well tolerated. This product brings a new hope for those patients who failed currently approved kinase inhibitors.”
As of September 30, 2021, Deciphera had $392 million in cash, cash equivalents, and marketable securities, which they believe can carry them into 2024 after the current restructuring. They expect a one-time cash charge this quarter of about $32 million associated with the workforce cuts and discontinuation of clinical development of rebastinib and ripretinib.
