Press Release

Netherlands Cancer Institute Intends to Sponsor and Conduct Phase 1/1b SHERPA Trial in Patients with Tumors Harboring RAS Mutations

REDWOOD CITY, Calif., March 09, 2020 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company focused on developing targeted therapies to inhibit frontier cancer targets, today announced its intention to support the Netherlands Cancer Institute (NKI) on a combination clinical study targeting two key nodes in the oncogenic RAS signaling pathway and to supply its investigational SHP2 inhibitor, RMC-4630, for this study. In addition, the American Association for Cancer Research (AACR) announced that the Pancreatic Cancer Collective, a strategic partnership of Stand Up To Cancer (SU2C) and the Lustgarten Foundation, has awarded up to $4 million in funding to researchers at the NKI to support the combination trial.  The Phase 1/1b trial would explore the combination of RMC-4630 with an investigational ERK inhibitor in solid tumors harboring RAS mutations with a focus on pancreatic cancer.  The AACR is the scientific partner of SU2C and has announced its intention to support the administration of the combination clinical study at the NKI. 

In an oral presentation at the recent RAS-Targeted Drug Discovery Europe Conference in Vienna, Austria, Sara Mainardi, Ph.D. summarized NKI’s intent to sponsor and conduct the SHERPA trial (SHP2 and ERK inhibitors in Pancreatic Cancer).  As reported in Dr. Mainardi’s presentation entitled “Targeting RAS-Driven Tumour by Exploiting Vulnerabilities in the RAS Network,” the NKI seeks to initiate the SHERPA trial in the second half of 2020. 

RMC-4630, Revolution Medicines’ investigational SHP2 inhibitor, is a potent and orally bioavailable small molecule that is designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a central role in modulating cell survival and growth by transmitting signals from receptor tyrosine kinases to RAS. NKI’s trial would represent a third announced combination study involving RMC-4630 in support of the company’s combination drug strategy to treat RAS cancers susceptible to adaptive resistance mechanisms. 

About RMC-4630 and Sanofi Collaboration

RMC-4630 is currently being evaluated in a Phase 1 monotherapy clinical trial (RMC-4630-01) for a range of tumor types featuring specific, molecularly-defined oncogenic mutations, as well as a Phase 1b/2 study (RMC-4630-02) in combination with cobimetinib in patients with relapsed/refractory solid tumors displaying specific genomic mutations.  A planned combination study of RMC-4630 and the KRAS^G12C(OFF) inhibitor, AMG 510, to be sponsored by Amgen, has been announced previously.

The SHP2 inhibitor program, including RMC-4630, is the focus of an exclusive global research, development and commercialization agreement with Sanofi.

About Revolution Medicines, Inc.

Revolution Medicines is a clinical-stage oncology company focused on developing novel targeted therapies to inhibit elusive high-value frontier cancer targets within notorious growth and survival pathways, with particular emphasis on RAS and mTOR signaling pathways. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.

The company’s pipeline includes RMC-4630, a clinical-stage drug candidate that is designed to selectively inhibit the activity of SHP2.  Additionally, the company is developing a broad portfolio of inhibitors of other key frontier oncology targets within the notorious RAS pathway, as well as the related mTOR signaling cascade.  These include inhibitors of multiple mutant RAS proteins and SOS1, as well as RMC-5552, a development candidate within the company’s 4EBP1/mTORC1 program currently in IND-enabling studies.

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 Revolution Medicines’ development plans and timelines, including without limitation the planned clinical study of RMC-4630 in combination with an investigational ERK inhibitor, and the potential benefits of, and markets for, Revolution Medicines’ product candidates. 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 our 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 Revolution Medicines’ 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, Revolution Medicines’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Revolution Medicines’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts and changes in the competitive landscape. 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’ prospectus filed with the Securities and Exchange Commission on February 13, 2020, 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.

Contacts: For Investors: Vida Strategic Partners Stephanie Diaz 415-675-7401 sdiaz@vidasp.com For Media: Vida Strategic Partners Tim Brons 415-675-7402 tbrons@vidasp.com