RVMD Revolution Medicines Inc - Ordinary Shares
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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RMC-4630 - RMC-4630-01
Solid tumors
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Phase 1
Phase 1
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RMC-4630 and cobimetinib - RMC-4630-02
Solid tumors
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Phase 1/2
Phase 1/2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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RMC-4630 and Keytruda
Non-small cell lung cancer (NSCLC) and colorectal cancer
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Phase 1b
Phase 1b
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Phase 1b initiation of dosing announced June 22, 2020.
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RMC-4630 and AMG 510
Solid tumors
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Phase 1b
Phase 1b
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Phase 1b initiation of dosing announced June 9, 2020.
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Latest News
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Recommended Phase 2 Dose and Schedule Selected for Further Evaluation of RMC-4630 as Monotherapy and RMC-4630 plus Cobimetinib Combination
First-in-Class RAS(ON) Inhibitor Programs for Five Targets in Lead Optimization
REDWOOD CITY, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced its financial results for the third quarter and nine months ended September 30, 2020, and provided a corporate update.
"Revolution Medicines is a leader in developing innovative medicines and treatment strategies on behalf of patients with RAS-addicted tumors. We are advancing a growing portfolio consisting of both direct RAS(ON) Inhibitors and RAS Companion Inhibitors designed to enable combination approaches, including RMC-4630 targeting SHP2, RMC-5552 targeting mTORC1, and inhibitors of SOS1," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.
"In our RAS Companion Inhibitor portfolio, we continue to make important strides with RMC-4630, our clinical stage inhibitor of SHP2. We selected the recommended Phase 2 dose and schedule (RP2DS) for both our monotherapy trial (RMC-4630-01) and the RMC-4630/cobimetinib (Cotellic®) combination arm of the RMC-4630-02 clinical trial, and each trial will further evaluate the appropriate RP2DS in expansion cohorts of molecularly selected patients. As anticipated, we recently dosed a first patient in a new combination study of RMC-4630 with the third-generation EGFR inhibitor, osimertinib (Tagrisso®). We also entered into a new clinical collaboration with AstraZeneca to study RMC-4630 in combination with an emerging asset targeting KRASG12C from AstraZeneca's portfolio.
"In addition, we accelerated growth of our RAS(ON) Inhibitor platform, which has produced a collection of potent, cell-active inhibitors of diverse oncogenic RAS variants responsible for the vast majority of RAS-addicted cancers. Previously, we demonstrated significant anti-tumor effects of a representative potent and oral inhibitor of KRASG12C(ON). During the third quarter we confirmed the broad scope of our platform by demonstrating that representative KRASG12D(ON) inhibitors likewise induced tumor regressions in a preclinical model of human pancreatic cancer harboring the oncogenic KRASG12D mutation. We have advanced our KRASG12C/NRASG12C(ON), KRASG12D(ON), KRASG13C(ON) and KRASG12V(ON) inhibitor programs into lead optimization."
R&D Highlights
RAS Companion Inhibitors
- Determined Recommended Phase 2 Dose and Schedule (RP2DS) for single agent RMC-4630 – Completed dose escalation and selected 200 mg administered on a Day 1/Day 2 (D1D2) weekly schedule as the RP2DS. The company plans to evaluate single agent RMC-4630 at the RP2DS in an expansion cohort of patients with gynecologic tumors harboring NF1LOF mutations, in addition to a small safety/tolerability cohort representing a broader set of histotypes and RAS pathway genotypes.
- Determined RP2DS for RMC-4630 in Combination with the MEK Inhibitor, Cobimetinib – Completed dose escalation and selected RMC-4630 140 mg and cobimetinib 40 mg administered on a Day 1/Day 2 (D1D2) weekly schedule as the RP2DS. The company plans to further evaluate this combination at the RP2DS in expansion cohorts of patients with colorectal cancer harboring KRASG12V or KRASG12D mutations and others drawing from a broader set of histotypes and RAS pathway genotypes.
- Interim Data Presented at ENA 2020 from Phase 1b/2 Clinical Trial Combining RMC-4630 with Cobimetinib – Interim data reported by investigators support a dual intermittent dosing strategy for RMC-4630 and cobimetinib that appears tolerable and exceeds target plasma exposures for each drug based on preclinical models of RAS pathway-driven cancers that project potential clinical activity. Investigators also reported preliminary evidence of anti-tumor activity in patients with colorectal cancer driven by KRAS mutations.
- RMC-4630 Multi-Cohort Phase 1/2 Clinical Program Expanding as Potential Backbone for Combination Therapies –
- Dosing and enrollment continue in the Amgen-sponsored Phase 1 study of RMC-4630 in combination with Amgen's KRASG12C(OFF) inhibitor, AMG 510, or sotorasib
- Dosing and enrollment continue in the Sanofi-sponsored Phase 1 study of RMC-4630 in combination with the PD-1 inhibitor, pembrozilumab (Keytruda®)
- Initiated a study evaluating RMC-4630 in combination with the EGFR inhibitor, osimertinib (Tagrisso®)
- Entered into a new clinical collaboration agreement with AstraZeneca to study RMC-4630 in combination with an emerging asset targeting KRASG12C from AstraZeneca's portfolio
- Dosing and enrollment continue in the Amgen-sponsored Phase 1 study of RMC-4630 in combination with Amgen's KRASG12C(OFF) inhibitor, AMG 510, or sotorasib
- Clinical Results Support Dual Mechanisms of Anti-Tumor Activity by RMC-4630: Tumor Cell-Intrinsic and Stimulation of Immune Response – Data reported by the company from its ongoing RMC-4630-01 trial provide clinical evidence that SHP2 inhibition may act by stimulating arms of the immune system as a second anti-tumor mechanism in addition to its tumor cell-intrinsic benefits. These observations provide further rationale for the ongoing clinical combination study with RMC-4630 and pembrozilumab by Sanofi, the company's SHP2 collaboration partner.
RAS(ON) Inhibitors
- First-In-Class RAS(ON) Inhibitor Platform – The company's proprietary tri-complex technology platform enables a highly differentiated approach to inhibiting RAS(ON) with potential biologic advantages. Revolution Medicines is developing a portfolio of compounds that it believes are the first and only RAS(ON) inhibitors to use this mechanism of action. The company has produced potent, cell-active RAS(ON) Inhibitors for variants driving the vast majority of RAS-addicted cancers.
- Inhibitors for Five RAS(ON) Variants in Lead Optimization – KRASG12C/NRASG12C(ON), KRASG12D(ON), KRASG13C(ON), and KRASG12V(ON) inhibitors are in lead optimization, which include and expands on the company's initial four priority RAS(ON) targets. The company remains on track to nominate a first development candidate from this platform by the end of 2020.
- Preclinical Tumor Regressions Induced by First-in-Class KRASG12D(ON) Inhibitors – Data presented by the company at the RAS Targeted Drug Development conference demonstrated that the company's first-in-class KRASG12D(ON) inhibitors induced significant decreases in tumor volume in a xenograft model of human pancreatic cancer driven by a KRASG12D mutation. The KRASG12D genotype is of particularly high clinical interest as there are currently no approved targeted therapies for the treatment of cancers driven by this mutation, which is found in approximately 35% of pancreatic cancers and 15% of colorectal cancers in the U.S.
Corporate Highlights
- Completed Follow-On Financing – The company completed a follow-on equity public offering in July 2020. The upsized financing raised gross proceeds of $179.4 million before deducting underwriting discounts, commissions and other offering expenses payable by Revolution Medicines, further strengthening its balance sheet to support multiple clinical milestones and extend the company's runway.
Upcoming Corporate Milestones
RAS(ON) Inhibitors
- Nominate first development candidate (Q4 2020)
- Nominate second development candidate (1H 2021)
RAS Companion Inhibitors
- SHP2 (RMC-4630)
- Report monotherapy dose escalation safety data set (1H 2021)
- Provide preliminary activity data for combination with cobimetinib (2H 2021)
- Provide initial tolerability and PK data for combination with osimertinib (2H 2021)
- mTORC1/4EBP1 (RMC-5552)
- Advance to IND-ready status (Q4 2020)
- Begin treating patients with monotherapy (1H 2021)
Third Quarter 2020 Financial Highlights
Cash Position: Cash, cash equivalents and marketable securities were $466.1 million as of September 30, 2020, compared to $122.8 million as of December 31, 2019. The increase was primarily due to proceeds from the company's initial public offering in February 2020 and follow-on equity public offering in July 2020.
Revenue: Total revenue, consisting of revenue from the company's collaboration agreement with Sanofi, was $12.7 million for the quarter ended September 30, 2020, compared to $12.5 million for the quarter ended September 30, 2019.
R&D Expenses: Research and development expenses were $34.9 million for the quarter ended September 30, 2020, compared to $23.0 million for the quarter ended September 30, 2019. This increase was primarily due to an increase in research expenses associated with the company's pre-clinical research portfolio, and an increase in personnel-related expenses related to additional headcount.
G&A Expenses: General and administrative expenses were $5.3 million for the quarter ended September 30, 2020, compared to $3.1 million for the quarter ended September 30, 2019. This increase was primarily due to an increase in expenses associated with operating as a public company.
Net Loss: Net loss was $27.2 million for the quarter ended September 30, 2020, compared to net loss of $12.8 million for the quarter ended September 30, 2019.
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. 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 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. RAS(ON) Inhibitors include compounds targeting KRASG12C/NRASG12C(ON), KRASG12D(ON), KRASG13C(ON), KRASG12V(ON) and other RAS variants. RAS Companion Inhibitors include RMC-4630 targeting SHP2, RMC-5552 targeting mTORC1, and inhibitors of SOS1.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Tagrisso® is a registered trademark of the AstraZeneca group of companies. Cotellic® is the registered trademark of Genentech, Inc. (a member of the Roche Group).
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 and its ability to advance its portfolio and R&D pipeline; enrollment in the company's clinical trials and the tolerability and potential efficacy of the company's candidates being studied; the ability of the company's therapies to inhibit frontier targets in RAS-addicted cancers; the company's planned expansion cohorts for single-agent RMC-4630 and RMC-4630 in combination with cobimetinib; the growth and scope of the company's RAS(ON) Inhibitor platform; the potential advantages and effectiveness of the company's preclinical candidates, including its RAS(ON) Inhibitors; the company's plans to nominate development candidates from its family of RAS(ON) Inhibitors; the company's plans to release data related to its RAS Companion Inhibitors; the company's plan to advance RMC-5552 to IND-ready status and to begin treating patients with RMC-5552 monotherapy. 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 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 our 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 November 12, 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.
REVOLUTION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)Three Months Ended
September 30,Nine Months Ended
September 30,2020 2019 2020 2019 Revenue: Collaboration revenue, related party $ 12,661 $ 12,506 $ 34,232 $ 37,953 Total revenue 12,661 12,506 34,232 37,953 Operating expenses: Research and development 34,871 22,962 95,246 64,265 General and administrative 5,341 3,103 15,603 8,244 Total operating expenses 40,212 26,065 110,849 72,509 Loss from operations (27,551 ) (13,559 ) (76,617 ) (34,556 ) Other income, net: Interest income 347 766 1,986 1,571 Interest and other expense (17 ) (25 ) (57 ) (83 ) Total other income, net 330 741 1,929 1,488 Loss before income taxes (27,221 ) (12,818 ) (74,688 ) (33,068 ) Benefit from income taxes — — 733 — Net loss $ (27,221 ) $ (12,818 ) $ (73,955 ) $ (33,068 ) Redeemable convertible preferred stock dividends - undeclared and cumulative — (4,247 ) (2,219 ) (9,987 ) Net loss attributable to common stockholders $ (27,221 ) $ (17,065 ) $ (76,174 ) $ (43,055 ) Net loss per share attributable to common stockholders - basic and diluted $ (0.42 ) $ (6.08 ) $ (1.49 ) $ (15.81 ) Weighted-average common shares used to compute net loss per share, basic and diluted 64,892,868 2,806,470 51,031,003 2,723,541 REVOLUTION MEDICINES, INC.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, unaudited)September 30, December 31, 2020 2019 Cash, cash equivalents and marketable securities $ 466,140 $ 122,758 Working capital (1) 440,514 90,929 Total assets 595,070 220,529 Deferred revenue 22,882 31,851 Total liabilities 90,000 67,994 Redeemable convertible preferred stock — 305,109 Total stockholders' equity (deficit) 505,070 (152,574 ) (1) Working capital is defined as current assets less current liabilities.
Contacts: For Investors: Vida Strategic Partners Stephanie Diaz 415-675-7401 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]
- Determined Recommended Phase 2 Dose and Schedule (RP2DS) for single agent RMC-4630 – Completed dose escalation and selected 200 mg administered on a Day 1/Day 2 (D1D2) weekly schedule as the RP2DS. The company plans to evaluate single agent RMC-4630 at the RP2DS in an expansion cohort of patients with gynecologic tumors harboring NF1LOF mutations, in addition to a small safety/tolerability cohort representing a broader set of histotypes and RAS pathway genotypes.
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Plenary Presentation at EORTC-NCI-AACR 32nd Symposium on Molecular Targets and Cancer Therapeutics Describes Encouraging Tolerability and Exposure Profiles for RMC-4630 Combined with Cobimetinib and Early Evidence of Clinical Activity in RASmut Colorectal Cancers
Company Also Announces New Clinical Collaboration with AstraZeneca to Study RMC-4630 in Combination with an Emerging AstraZeneca Asset Targeting KRASG12C
REDWOOD CITY, Calif., Oct. 24, 2020 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today reported interim data from the company's ongoing Phase 1b/2 clinical trial (RMC-4630-02) evaluating the combination of RMC-4630 and cobimetinib (Cotellic®) in an oral presentation by Johanna C. Bendell, M.D., Sarah Cannon Research Institute, Nashville, TN in a plenary session at the EORTC-NCI-AACR 32nd Symposium on Molecular Targets and Cancer Therapeutics (ENA 2020). Interim results suggest that a dual intermittent dosing strategy for RMC-4630 and cobimetinib exceeds target plasma exposures for each drug based on preclinical models of RAS pathway-driven cancers that project potential clinical activity. The adverse event profile of the combination, which was consistent with expected on-pathway effects of both drugs, was tolerable under the dual intermittent dosing schedule.
The ongoing Phase 1b/2 RMC-4630-02 trial includes an open-label, dose-escalation and dose-expansion study arm designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of RMC-4630 and cobimetinib in adult patients with relapsed/refractory solid tumors that harbor specific genomic RAS pathway mutations. The results of this study will inform Revolution Medicines' pending selection of a recommended Phase 2 dose and schedule for the drug combination to be evaluated further in one or more expansion cohorts of patients selected by tumor genotype and histotype that are expected to initiate in 2020.
While evaluation of efficacy outcomes is not a primary objective of the dose escalation portion of the RMC-4630-02 study, investigators reported preliminary evidence of anti-tumor activity in patients with colorectal cancer driven by KRAS mutations. As of the data cut-off date, tumor volume reduction was observed in three of seven patients with colorectal cancers harboring KRAS mutations who were treated at the highest dose of RMC-4630, including one unconfirmed partial response in a patient carrying a KRASG12D mutation.
Expansion of Combination Program
Revolution Medicines also announced that it has signed an agreement with AstraZeneca (NASDAQ:AZN) to enter a clinical collaboration to study RMC-4630 in combination with an emerging asset from AstraZeneca's preclinical efforts targeting KRASG12C. Under the agreement, AstraZeneca will sponsor and conduct this combination study and Revolution Medicines will provide clinical supply of RMC-4630.
Separately, Revolution Medicines and Amgen are collaborators in an ongoing Amgen-sponsored clinical trial studying RMC-4630 in combination with AMG 510 (soratinib), an investigational KRASG12C(OFF) inhibitor.
"Drug combinations are likely to be critical for defeating inherent drug resistance mechanisms exploited by RAS-addicted cancers, and both the data presented at ENA 2020 and the new clinical collaboration announced today represent important steps forward in developing RMC-4630 as a backbone of such combination therapies. The ENA presentation focuses on cancers with RAS mutations lacking a mutant-selective inhibitor, and suggest that RMC-4630 and cobimetinib can be combined through an innovative dual intermittent dosing schedule to drive anti-tumor activity in advanced colorectal cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We are currently refining a recommended Phase 2 dose and schedule to evaluate further for safety, tolerability and anti-tumor activity in dedicated expansion patient cohort(s)."
"We are also excited to collaborate with AstraZeneca to study RMC-4630 in combination with an emerging asset from AstraZeneca's pipeline targeting KRASG12C(OFF) for tumors carrying a KRASG12C mutation, a planned study that represents an expansion of our commitment to RMC-4630 as a backbone for combinations with RAS-mutant inhibitors. We also continue growing our exciting pipeline of direct inhibitors of oncogenic RAS(ON) variants, including our direct inhibitors of KRASG12C(ON) and KRASG12D(ON) currently in lead optimization."
RMC-4630 and cobimetinib are targeted inhibitors of oncogenic proteins at distinct positions within the RAS signaling cascade that is frequently exploited by human cancers and may develop adaptive resistance to single agent treatment. RMC-4630 is a potent and orally bioavailable small molecule designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a key role in modulating cell growth by transmitting signals from receptor tyrosine kinases to RAS. Cobimetinib, marketed in the U.S. by Genentech, a member of the Roche group, inhibits the activity of MEK, a downstream effector of RAS that affects cell survival and growth. Cobimetinib is approved in the U.S. for the treatment of patients with BRAFV600E or BRAFV600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib (Zelboraf®). Cobimetinib is provided by Genentech for the RMC-4630-02 study under a clinical collaboration agreement with Revolution Medicines.
About RMC-4630
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, a Phase 1b/2 trial (RMC-4630-02) in combination with cobimetinib in patients with relapsed/refractory solid tumors displaying specific genomic mutations, a Phase 1b study (CodeBreaK 101) in combination with AMG 510 in patients with advanced solid tumors harboring the KRASG12C mutation, and a Phase 1 study in combination with pembrozilumab in patients with advanced malignancies.
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 precision oncology company developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. 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 R&D pipeline comprises RAS(ON) Inhibitors designed to suppress various oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors include compounds targeting KRASG12C(ON), KRASG12D(ON) and other RAS variants. RAS Companion Inhibitors include RMC-4630 targeting SHP2, RMC-5552 targeting mTORC1, and inhibitors of SOS1.
Cotellic® is the registered trademark of Genentech, Inc. (a member of the Roche Group).
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 results of the ongoing RMC-4630-02 trial and Revolution Medicines' ability to select a recommended Phase 2 dose and schedule for this combination and to evaluate one or more expansion cohorts, statements regarding the proposed combination study with AstraZeneca, the ability of drug combinations to defeat drug resistance mechanisms exploited by RAS-addicted cancers, the utility of RMC-4630 as a backbone for combination treatments and the company's ability to develop it in this capacity, the growth of the company's pipeline of RAS(ON) inhibitors, and the potential benefits of, and markets for, Revolution Medicines' potential 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, changes in the competitive landscape and the effects on our 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 10, 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 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]
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REDWOOD CITY, Calif., Oct. 12, 2020 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced that interim data from the company's ongoing Phase 1b/2 clinical trial (RMC-4630-02) evaluating the combination of RMC-4630 and cobimetinib (Cotellic®) will be reported in an oral presentation in a plenary session at the upcoming EORTC-NCI-AACR 32nd Symposium on Molecular Targets and Cancer Therapeutics (ENA 2020) being held virtually October 24-25, 2020.
The ongoing Phase 1b/2 RMC-4630-02 trial is an open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of RMC-4630 and cobimetinib in adult patients with relapsed/refractory solid tumors that harbor specific genomic mutations. The study tested several dosing regimens, including intermittent RMC-4630 plus daily or intermittent cobimetinib. Preliminary data to be presented at ENA 2020 will focus on safety, tolerability and pharmacokinetic findings from combination dosing regimens.
"We are gratified that data from our ongoing combination trial of RMC-4630 and cobimetinib were selected for presentation at ENA 2020. Drug combinations will likely be critical to defeating inherent drug resistance mechanisms exploited by RAS-addicted cancers," said Steve Kelsey, M.D., president of research and development at Revolution Medicines. "We remain keenly focused on testing the clinical hypothesis that RMC-4630 may be useful as a backbone for various combination treatments designed for different cancers with distinct molecular profiles."
Details of the upcoming oral presentation at ENA 2020 are as follows:
- Title: Intermittent dosing of RMC-4630, a potent, selective inhibitor of SHP2, combined with the MEK inhibitor cobimetinib, in a Phase 1b/2 clinical trial for advanced solid tumors with activating mutations of RAS signaling
- Session: Plenary Session 1: Late-Breaking and Best Proffered Papers
- Presenting Author: Johanna C. Bendell, M.D., Sarah Cannon Research Institute, Nashville, Tennessee
- Presentation Date/Time: Saturday, October 24, 2020, 3:45 – 3:55 p.m. CEST (9:45 – 9:55 a.m. Eastern/6:45 – 6:55 a.m. Pacific)
- Live Virtual Q&A: To follow completion of Plenary Session 1 presentations
RMC-4630 and cobimetinib are targeted inhibitors of oncogenic proteins at distinct positions within the RAS signaling cascade that is frequently exploited by human cancers and may develop adaptive resistance to single agent treatment. RMC-4630 is a potent and orally bioavailable small molecule designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a key role in modulating cell growth by transmitting signals from receptor tyrosine kinases to RAS. Cobimetinib, marketed in the U.S. by Genentech, a member of the Roche group, inhibits the activity of MEK, a downstream effector of RAS that affects cell survival and growth. Cobimetinib is approved in the U.S. for the treatment of patients with BRAFV600E or BRAFV600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib (Zelboraf®).
About RMC-4630
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, a Phase 1b/2 trial (RMC-4630-02) in combination with cobimetinib in patients with relapsed/refractory solid tumors displaying specific genomic mutations, a Phase 1b study (CodeBreaK 101) in combination with AMG 510 in patients with advanced solid tumors harboring the KRASG12C mutation, and a Phase 1 study in combination with pembrozilumab in patients with advanced malignancies.
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 precision oncology company developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. 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 R&D pipeline comprises RAS(ON) Inhibitors designed to suppress various oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors include compounds targeting KRASG12C(ON), KRASG12D(ON) and other RAS variants. RAS Companion Inhibitors include RMC-4630 targeting SHP2, RMC-5552 targeting mTORC1, and inhibitors of SOS1.
Cotellic® is the registered trademark of Genentech, Inc. (a member of the Roche Group).
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 ongoing RMC-4630-02 trial, the ability of drug combinations to defeat drug resistance mechanisms exploited by RAS-addicted cancers, the utility of RMC-4630 as a backbone for combination treatments, and the potential benefits of, and markets for, Revolution Medicines' potential 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, changes in the competitive landscape and the effects on our 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 10, 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 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]
- Title: Intermittent dosing of RMC-4630, a potent, selective inhibitor of SHP2, combined with the MEK inhibitor cobimetinib, in a Phase 1b/2 clinical trial for advanced solid tumors with activating mutations of RAS signaling
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Presentation at 2nd Annual RAS-Targeted Drug Development Conference Highlights First Publicly Reported Data for Inhibitors of Notorious Cancer Protein KRASG12D(ON)
REDWOOD CITY, Calif., Sept. 16, 2020 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today reported data demonstrating that its first-in-class KRASG12D(ON) inhibitors induced tumor regressions in a preclinical model of human pancreatic cancer carrying an oncogenic KRASG12D mutation. This first public disclosure of results showing anti-tumor activity for potent inhibitors of the notorious KRASG12D(ON) cancer protein was made by Steve Kelsey, M.D., president of research and development, in a presentation entitled "Approaches to Inhibiting RAS Driven Tumors Beyond KRASG12C" at the 2nd Annual RAS-Targeted Drug Development Conference.
Revolution Medicines uses its proprietary tri-complex technology platform to create innovative compounds designed to inhibit the active, GTP-bound form of RAS, or RAS(ON), proteins. The company previously reported representative preclinical profiles of its potent inhibitors of another common cancer driver, KRASG12C(ON). The newly presented data demonstrated that its KRASG12D(ON) inhibitors induced significant decreases in tumor volume in a xenograft model of human pancreatic cancer driven by a KRASG12D mutation. This anti-tumor activity was observed across multiple dose levels, and all dose levels were well tolerated. The KRASG12D(ON) program is currently in lead optimization.
The KRASG12D genotype is of particularly high clinical interest as there are currently no approved targeted therapies for the treatment of cancers driven by this mutation, which is found in approximately 35 percent of pancreatic cancer cases and 15 percent of colorectal cancers in the U.S. The company continues its efforts to discover and develop inhibitors of multiple oncogenic mutants of RAS proteins, which in aggregate are believed to drive approximately 30% of all human cancers in the U.S. Earlier in 2020 the company named KRASG12C, KRASG12D, KRASG13C and NRASG12C as its four initial priority RAS(ON) targets.
"It is gratifying for our R&D organization to present this exciting demonstration of preclinical anti-cancer activity of compounds targeting the oncogenic KRASG12D(ON) protein. Advancement of our KRASG12D(ON) inhibitor program into the lead optimization stage represents an important corporate milestone, and highlights the substantial progress that we continue to make across our broad-based mutant RAS(ON) inhibitor effort," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We believe that targeted inhibitors directed to mutant forms of RAS that drive various cancers, and in particular the RAS(ON) form of these proteins, represent a potential therapeutic strategy for serving important unmet needs on behalf of patients battling RAS-driven cancers."
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. 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 R&D pipeline includes RMC-4630, a clinical-stage investigational drug that is designed to selectively inhibit the activity of SHP2, an upstream node in RAS signaling. Preclinical programs include inhibitors of multiple mutant RAS proteins and SOS1. RMC-5552, currently in IND-enabling development, is designed for use against tumors featuring mTORC1 activation, including certain RAS-addicted cancers.
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 potential anti-tumor activity of RAS(ON) inhibitors in KRASG12D or other mutant RAS(ON) driven tumors, Revolution Medicines' efforts to discover and develop inhibitors of multiple oncogenic mutants of RAS proteins and the potential benefits of, and markets for, Revolution Medicines' potential 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, changes in the competitive landscape and the effects on our 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 10, 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 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]
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REDWOOD CITY, Calif., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced that Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman, will deliver a corporate presentation as part of the H.C. Wainwright 22nd Annual Global Investment Conference. The conference, which will take place September 14-16, 2020, is being conducted with a virtual format.
Dr. Goldsmith's presentation will take place at 11:00 a.m. Eastern on Monday, September 14, 2020. A live webcast of the presentation will be available. To access the live webcast of the presentation, please visit the "Events & Presentations" page within the Investors section of Revolution Medicines' website at https://ir.revmed.com/events-and-presentations. Additionally, a replay of the webcast will be available on the "Events & Presentations" page of the Revolution Medicines' website following the conference.
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. 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 R&D pipeline includes RMC-4630, a clinical-stage investigational drug that is designed to selectively inhibit the activity of SHP2, an upstream node in RAS signaling. Preclinical programs include inhibitors of multiple mutant RAS proteins and SOS1. RMC-5552, currently in IND-enabling development, is designed for use against tumors featuring mTORC1 activation, including certain RAS-addicted cancers.
Contacts: For Investors: Vida Strategic Partners Stephanie Diaz 415-675-7401 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]