On January 10, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported a corporate update and highlighted key 2022 milestones in conjunction with its presentation at the 40th Annual J.P. Morgan Healthcare Conference (Press release, Deciphera Pharmaceuticals, JAN 10, 2022, View Source [SID1234598505]). The Company will webcast its presentation today at 9:00 AM ET at View Source
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"Deciphera is well-positioned as we enter 2022 with multiple high-value clinical programs and a successful commercial franchise in QINLOCK, all generated by our proven and productive research engine," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "We are excited about our leading portfolio of novel kinase inhibitors, including our first-in-class autophagy pathway inhibitor, DCC-3116, and our newly disclosed pan-RAF research program, both of which seek to address the challenges of drug resistance in patients with cancer. We believe that DCC-3116, designed to inhibit the autophagy pathway by inhibiting the ULK kinase, has the potential to address a broad range of human cancers, and planning is now underway to expand this development program to include a KRAS G12C inhibitor combination in non-small cell lung cancer (NSCLC). We plan to present initial data from the single agent dose escalation portion of this Phase 1 study later this year. We also announced today our plans to nominate a new clinical development candidate from our pan-RAF research program later this year, which we believe has the potential to be a best-in-class agent that can address unmet medical needs as a single agent and in combination."
Mr. Hoerter continued, "We kicked off 2022 with the launch of QINLOCK in Germany and we plan to transition to a post-approval paid access program in France in the first half of this year. Our existing QINLOCK commercial footprint with sarcoma specialists also serves as an excellent foundation for the future commercialization of our potential best-in-class CSF1R inhibitor, vimseltinib. The Phase 3 MOTION study of vimseltinib in tenosynovial giant cell tumor (TGCT) is currently underway and we expect to present updated data from our Phase 1/2 study in patients with TGCT later this year."
In 2022, the Company seeks to achieve the following milestones:
QINLOCK (ripretinib)
Execute on the commercial launch of QINLOCK in fourth-line GIST in Germany. Launch in Germany is ongoing as of January 1, 2022.
Transition to post-approval paid access program in France in the first half of 2022.
Present results of the Phase 3 INTRIGUE study in second-line GIST at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series Session on January 25, 2022.
Vimseltinib
Enrollment underway in the Phase 3 MOTION study of vimseltinib, an orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R, for the treatment of TGCT.
Present updated data from the Phase 1/2 study in TGCT patients in the second half of 2022.
DCC-3116
Present data from the single agent dose escalation portion of this Phase 1 study of DCC-3116, a first-in-class ULK kinase inhibitor designed to inhibit autophagy for the treatment of patients with advanced or metastatic tumors with a mutant a RAS or RAF gene, in the second half of 2022. DCC-3116 is currently being investigated as a single agent and in combination.
Initiate Phase 1 study dose expansion in the second half of 2022 in combination with trametinib, a U.S. Food and Drug Administration-approved MEK inhibitor, in patients with selected mutations in advanced or metastatic pancreatic ductal adenocarcinoma, NSCLC, colorectal cancer, and melanoma.
Planning underway to add a combination with a KRAS G12C inhibitor in NSCLC to the ongoing Phase 1 study, subject to feedback from regulatory authorities.
Present additional preclinical data for DCC-3116 in 2022 and continue to explore preclinical combinations of DCC-3116 with multiple additional targeted oncology agents with diverse mechanisms of action.
Proprietary Drug Discovery Platform
Nominate a development candidate in 2022 from the pan-RAF inhibitor research program, discovered using the Company’s novel switch-control inhibitor platform.
Presentation at the 40th Annual J.P. Morgan Healthcare Conference
Deciphera will webcast its corporate presentation from the 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2022 at 9:00 AM ET. A live webcast of the presentation can be accessed under "Events & Presentations" in the investors section of the Company’s website at deciphera.com. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation. In conjunction with the conference, the Company has also updated its corporate presentation, which can be found here: View Source