ERAS-007, a potential best-in-class ERK1/2 inhibitor, is being evaluated in combination with encorafenib and cetuximab in BRAF V600E-mutant metastatic colorectal cancer
Erasca previously signed CTCSAs with Pfizer and Eli Lilly to evaluate encorafenib and cetuximab in combination with ERAS-007
SAN DIEGO, Nov. 30, 2022 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced a clinical trial collaboration and supply agreement (CTCSA) with Pierre Fabre for the BRAF inhibitor encorafenib (BRAFTOVI®) within key international territories.
This agreement will support a clinical proof-of-concept trial evaluating ERAS-007, an oral ERK1/2 inhibitor, in combination with encorafenib and the anti-EGFR antibody cetuximab for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). This combination is being investigated as part of the ongoing Phase 1b/2 HERKULES-3 master protocol in patients with gastrointestinal (GI) malignancies. Erasca will sponsor the trial, and Pierre Fabre will supply encorafenib in the Pierre Fabre territories which include Europe and Asia Pacific (excluding Japan and South Korea).
“We are excited to work with Pierre Fabre, a leader in precision oncology, on an international collaboration to explore ERAS-007 in combination with encorafenib and cetuximab in BRAF mCRC,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “This partnership complements our existing CTCSA with Pfizer for encorafenib within the United States and other markets. Resistance mechanisms, particularly through MAPK reactivation, limit long-term benefit with current standard of care BRAF-targeted treatments. By blocking RAS/MAPK pathway signaling at the most distal node, ERK1/2, ERAS-007 can potentially prevent pathway reactivation.”
Worldwide, approximately 1.8 million cases of CRC are diagnosed annually, with BRAF V600E mutations occurring in approximately 10% of these patients. Encorafenib in combination with cetuximab was approved by the FDA in April 2020 for previously treated patients with BRAF V600E-mutant mCRC. While the combination demonstrated improved overall survival over chemotherapy, only 20% of patients experienced an objective response, with a progression-free survival of approximately four months. Emergence of resistance remains a major therapeutic barrier to long-term clinical benefit. Erasca is exploring whether ERK inhibition with ERAS-007 in combination with encorafenib plus cetuximab can reduce the emergence of resistance and further improve treatment benefit for patients with BRAF V600E-mutant mCRC.
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across the series of HERKULES clinical trials that span multiple tumor types and includes both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer (NSCLC). HERKULES-3 is a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with GI cancers.
At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of cancer. We have assembled what we believe to be the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.
Cautionary Note Regarding Forward-Looking Statements
Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates, including ERAS-007; our beliefs regarding market sizes and opportunities; and the planned advancement of our development pipeline, including the clinical development plans for each of the HERKULES series of trials, and our ability to realize the benefits of the CTCSA described in this press release. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; delays in our preclinical and clinical development programs; our dependence on third parties in connection with manufacturing, the supply of third-party drugs, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; the inability to realize any benefits from our current licenses, CTCSAs, and acquisitions and any future licenses, CTCSAs, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; our ability to fund our operating plans with our current cash, cash equivalents, and investments; our ability to maintain undisrupted business operations due to the COVID-19 pandemic; unstable market and economic conditions having serious adverse consequences on our business, financial condition and stock price; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent annual report on Form 10-K for the year ended December 31, 2021, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
BRAFTOVI® is a registered trademark owned by or licensed to Pfizer Inc., its subsidiaries, or affiliates.
LifeSci Advisors, LLC
Source: Erasca, Inc.
Source: Erasca, Inc.