Revolution Medicines Doses First Patient in Phase 1/1b Clinical Trial of RMC-9805, an Oral, Covalent, Mutant-Selective KRASG12D(ON) Inhibitor
19 Setembro 2023 - 8:00AM
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).
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 dosing and
enrollment in the company’s clinical trials and the tolerability,
potential efficacy and utility of the company’s candidates being
studied; and the ability of the company to change the standard of
care for patients living with a wide range of RAS-addicted cancers.
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 August 8, 2023, 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.
Investors & Media Contact:
Erin Graves
650-779-0136
egraves@revmed.com
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