Revolution Medicines Advances First RAS(ON) Inhibitor into Clinic, Dosing First Patient in Phase 1/1b Trial of RMC-6236

First-in-class, oral, RAS(ON) Inhibitor being evaluated initially in patients with cancers driven by KRAS^G12 mutations

Sushil Patel, Ph.D., industry veteran with commercial oncology expertise, elected to board of directors

REDWOOD CITY, Calif., June 28, 2022 (GLOBE NEWSWIRE) — 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-6236, the company’s oral, potent, tri-complex RAS(ON) Inhibitor designed to treat patients with cancers driven by a variety of RAS mutations. RMC-6236, which the company refers to as a RAS^MULTI (ON) Inhibitor, is the first development candidate from Revolution Medicines’ portfolio of novel RAS(ON) Inhibitors to enter clinical development.

The Phase 1/1b trial (NCT05379985) is a multicenter, open-label, dose-escalation and dose-expansion study of RMC-6236 in patients with advanced solid tumors harboring selected KRAS^G12 mutations, including KRAS^G12D, KRAS^G12V and KRAS^G12R. The primary objectives of the study are to evaluate safety and tolerability and to inform the recommended Phase 2 dose and schedule (RP2DS) for the compound. The study’s first patient has pancreatic cancer with a KRAS^G12D mutation, the most common genetic variant of RAS proteins causing cancer.  

“Beginning clinical evaluation of the first compound from our broad portfolio of RAS(ON) Inhibitors marks a significant milestone in our efforts to serve unmet needs of patients with RAS-addicted cancers,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “To our knowledge, RMC-6236 is the first oral, direct RAS inhibitor to be deployed against a tumor harboring the KRAS^G12D variant, and it ushers in a wave of groundbreaking RAS(ON) Inhibitors we expect to advance.”

Steve Kelsey, M.D., president, research and development at Revolution Medicines said, “RMC-6236 is a compelling drug candidate with the potential to demonstrate broad utility across many RAS cancer variants, particularly those harboring KRAS^G12 mutations. We are enthusiastic about its potential both to display first-in-class single agent activity as an inhibitor of mutant RAS and to be deployed as a RAS Companion Inhibitor in combination with mutant-selective RAS(ON) Inhibitors we have in development.”

The company also highlights the election of Sushil Patel, Ph.D., to its board of directors at its recent annual meeting of stockholders. Dr. Patel has more than twenty years of experience in the biotech industry, focused on commercialization strategy and execution in U.S. and global oncology markets. He currently serves as chief commercial officer of Replimune Group, a clinical-stage biotechnology company developing novel tumor-directed oncolytic immunotherapies. Previously, Dr. Patel held various positions at Genentech, Inc., where he served as franchise head for lung, skin, and rare cancers that included several blockbuster products in both targeted therapies and immuno-oncology. Notably, he led lifecycle management of Tecentriq® (atezolizumab) in lung cancer and helped lead more than eight product launches across more than twenty different indications. Dr. Patel holds a Ph.D. in molecular biology from the University of London and a Master’s degree in biotechnology from the Imperial College London.

Dr. Goldsmith added, “We are very fortunate to have Sushil join our board of directors. His commercial expertise in bringing innovative cancer drugs to patients will provide a valuable perspective as we advance our deep product pipeline.”

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) Inhibitor RMC-6236 (RAS^MULTI) is in clinical development. Additional RAS(ON) Inhibitors in development include RMC-6291(KRAS^G12C), RMC-9805 (KRAS^G12D) and RMC-8839 (KRAS^G13C), and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in clinical development include RMC-4630 (SHP2) and RMC-5552 (mTORC1/4EBP1).

Tecentriq® is a registered trademark of Genentech, Inc.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the company’s development plans and timelines and its ability to advance its portfolio and R&D pipeline, including its RAS(ON) inhibitors; dosing and enrollment in the company’s clinical trials and the tolerability, potential efficacy and utility of the company’s candidates being studied; the ability of the company’s therapies to serve unmet needs of patients with RAS-addicted cancers; the ability of RMC-6236 to display first-in-class activity or serve as a combination agent with mutant-selective RAS(ON) inhibitors. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on the company’s business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2022, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.

CONTACT: Contact Information

David S. Arrington
SVP Investor Relations & Corporate Affairs
Revolution Medicines
650-542-6046
darrington@revmed.com