ERAS-601, a potential best-in-class SHP2 inhibitor, is being investigated alone and in combination in the ongoing FLAGSHP-1 Phase 1/1b trial
Erasca previously signed CTCSAs with Lilly and Pfizer to evaluate cetuximab and encorafenib in combination with ERK1/2 inhibitor ERAS-007
SAN DIEGO, July 18, 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 that it has entered into a clinical trial collaboration and supply agreement (CTCSA) with Eli Lilly and Company for Lilly’s anti-EGFR antibody cetuximab (ERBITUX®).
This agreement will support Erasca’s ongoing Phase 1/1b FLAGSHP-1 trial, a clinical proof-of-concept trial evaluating ERAS-601, an oral SHP2 inhibitor, in various combinations, including with cetuximab for the treatment of triple wildtype (KRAS/NRAS/BRAF wildtype) metastatic colorectal cancer (CRC) and human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC). Erasca is the sponsor of the trial, and Lilly is supplying cetuximab at no cost. Erasca previously signed CTCSAs with Lilly and Pfizer, respectively, to evaluate cetuximab and encorafenib (BRAFTOVI®) in combination with Erasca’s ERK1/2 inhibitor, ERAS-007, as part of Erasca’s HERKULES-3 Phase 1b/2 trial.
“We are pleased to enter another clinical trial collaboration with Lilly to explore cetuximab in combination with ERAS-601, our SHP2 inhibitor, in EGFR-driven cancers that are highly dependent on RAS/MAPK signaling,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Dual inhibition of EGFR and SHP2, a convergent RTK signaling node, has the potential to broaden and deepen responses relative to cetuximab monotherapy and delay onset of resistance in cancers like triple wildtype metastatic CRC and HPV-negative advanced HNSCC.”
Approximately 1.5 million cases of CRC are diagnosed annually worldwide, with triple wildtype CRC, representing nearly 50% of all cases. HNSCC is one of the most common cancers worldwide, with around 0.7 million new cases annually of which 70-75% are HPV-negative HNSCC. While there are treatment options available in these tumor types, treatment resistance continues to limit long-term durability. The clinical development of this combination was supported by preclinical data Erasca presented at the 2022 American Association for Cancer Research (AACR) annual meeting demonstrating ERAS-601 in combination with cetuximab enhanced anti-proliferative activity and inhibited tumor growth over either agent alone in models of HPV-negative HNSCC and triple wildtype CRC.
ERAS-601 is a potential best-in-class oral, selective SHP2 inhibitor being investigated alone or in combination. SHP2 acts as a convergent node for receptor tyrosine kinase (RTK) signaling, relaying growth and survival signals from RTKs to intracellular signaling pathways. ERAS-601 is being investigated across a series of clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents. FLAGSHP-1 is a Phase 1/1b dose escalation trial evaluating ERAS-601 as a monotherapy in advanced solid tumors and in combination in triple wildtype CRC and HPV-negative HNSCC. HERKULES-2 is a Phase 1b/2 master protocol clinical trial that includes evaluation of ERAS-601 in combination with various agents in patients with non-small cell lung cancer.
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-601 and ERAS-007; our expectations regarding the preclinical data for ERAS-601 being indicative of future clinical results; our beliefs regarding market sizes and opportunities; and the planned advancement of our development pipeline, including the clinical development plans for ERAS-601 and ERAS-007. 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 to conduct manufacturing, 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; 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 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.
ERBITUX® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
BRAFTOVI® is a registered trademark owned by or licensed to Pfizer Inc., its subsidiaries, or affiliates.
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Source: Erasca, Inc.