Revolution Medicines Doses First Patient in Phase 1/1b Clinical Trial of RMC-9805, an Oral, Covalent, Mutant-Selective KRASG12D(ON) Inhibitor
- Category: Small Molecules
- Published on Tuesday, 19 September 2023 16:40
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KRASG12D(ON) Inhibitor with highly differentiated mechanism of action being evaluated in patients with cancers harboring the KRASG12D mutation, the most common driver of RAS-addicted human cancers
REDWOOD CITY, CA, USA I September 19, 2023 I Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced the first patient was dosed in its Phase 1/1b monotherapy clinical trial of RMC-9805, an oral, covalent, mutant-selective KRASG12D(ON) Inhibitor designed to treat patients with cancers driven by the KRASG12D mutation. KRASG12D is the most common driver of RAS-addicted human cancers, accounting for nearly 55,000 newly diagnosed patients in the U.S. annually, predominantly among patients with pancreatic cancer, non-small cell lung cancer (NSCLC), and colorectal cancer.
The Phase 1/1b trial (NCT06040541) is a multicenter, open-label, dose-escalation and dose-expansion study of RMC-9805 in patients with advanced solid tumors harboring the KRASG12D mutation. The primary objectives of the study are to evaluate safety and tolerability, and to inform the recommended Phase 2 dose and schedule for the compound.
“The initiation of patient dosing with RMC-9805 marks a major milestone for Revolution Medicines as its third oral RAS(ON) Inhibitor to begin clinical evaluation,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “We are now sudying in the clinic three highly innovative RAS(ON) Inhibitors derived from our pioneering tri-complex inhibitor platform that we believe have complementary profiles – RMC-6236 (RASMULTI) for patients with cancers caused by a wide range of RAS mutations, and the mutant-selective compounds RMC-6291 (KRASG12C) and RMC-9805 (KRASG12D) for patients with cancers harboring selected mutations. With this strong clinical portfolio, as well as a rich collection of additional mutant-selective drug candidates and research-stage assets, we believe our pipeline has the potential to change the standard of care for patients living with a wide range of RAS-addicted cancers including NSCLC, pancreatic cancers and colorectal cancers.”
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. The company’s RAS(ON) Inhibitors RMC-6236 (RASMULTI), RMC-6291 (KRASG12C) and RMC-9805 (KRASG12D) are currently in clinical development. Additional RAS(ON) Inhibitors in the company’s pipeline include RMC-0708 (KRASQ61H) which is currently in IND-enabling development, RMC-8839 (KRASG13C), and additional compounds targeting other RAS variants. RAS Companion Inhibitors in clinical development include RMC-4630 (SHP2) and RMC-5552 (mTORC1/4EBP1).
SOURCE: Revolution Medicines