Erasca and MD Anderson Announce Strategic Research and Development Collaboration in RAS/MAPK-Driven Cancers

Initial focus of five-year collaboration will be on potentially best-in-class ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601, which together comprise Erasca’s first MAPKlamp combination

Additional Erasca programs, including KRAS G12D inhibitor ERAS-4, also will be investigated under the alliance

SAN DIEGO and HOUSTON, Aug. 23, 2022 (GLOBE NEWSWIRE) -- (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, and (MD Anderson), today announced a strategic research and development collaboration to evaluate multiple agents from Erasca’s pipeline targeting the RAS/MAPK pathway as either single-agent or combination therapies.

The initial focus of the alliance will be Erasca’s potentially best-in-class ERK1/2 inhibitor ERAS-007 and its potentially best-in-class SHP2 inhibitor ERAS-601, which together comprise Erasca’s first MAPKlamp combination. ERAS-007 is being investigated in multiple ongoing trials, including in non-small cell lung cancer (NSCLC) as part of the HERKULES-2 master protocol and in gastrointestinal (GI) malignancies as part of the HERKULES-3 master protocol. ERAS-601 is being investigated in multiple ongoing trials, including the FLAGSHP-1 trial in triple wildtype (KRAS/NRAS/BRAF wildtype) colorectal cancer (CRC) and human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC) and the HERKULES-2 NSCLC master protocol.

“Our strategic collaboration with MD Anderson broadens the evaluation of ERAS-007 and ERAS-601 and explores additional therapeutic opportunities across our pipeline,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “The RAS/MAPK pathway is one of cancer’s most frequently altered pathways, affecting more than 5 million new patients with cancer annually worldwide. We have designed our pipeline to comprehensively shut down this highly oncogenic pathway at multiple critical nodes, and we’re excited to work with MD Anderson to potentially address major unmet needs in the treatment of cancer.”

The alliance will build on Erasca’s existing collaborations with MD Anderson investigators , professor of , and , professor of . Kopetz is an investigator in HERKULES-3, which is evaluating ERAS-007 plus encorafenib and cetuximab in BRAF V600E-mutant metastatic CRC and ERAS-007 plus palbociclib in KRAS-mutant/NRAS-mutant CRC and KRAS-mutant pancreatic cancer. Hong is an investigator in FLAGSHP-1, which is evaluating ERAS-601 as monotherapy and in combination with cetuximab in triple wildtype CRC and HPV-negative advanced HNSCC.

“Durability and treatment resistance continue to present challenges in the treatment of lung cancers and GI malignancies, particularly stemming from reactivation of the RAS/MAPK pathway. Erasca’s pipeline of agents that target key nodes, including previously undruggable genetic drivers, has the potential to improve durability and minimize resistance,” Kopetz said. “We look forward to collaborating with Erasca to further maximize the potential of promising treatment combinations across its pipeline.”

The new strategic collaboration will enhance Erasca’s and MD Anderson’s evaluation of ERAS-007 and ERAS-601 in combination with investigational and standard-of-care agents, including with Erasca’s proprietary pipeline programs, such as the KRAS G12D inhibitor ERAS-4. Under the terms of the five-year agreement, collaborative preclinical and clinical studies will be conducted in NSCLC, GI malignancies and additional mutually agreed-upon indications.

About ERAS-007

ERAS-007 is a potential best-in-class oral 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. The broad therapeutic potential of ERAS-007 is being investigated initially across a series of HERKULES clinical trials that span multiple tumor types and include 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 combination) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with NSCLC. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with GI cancers.

About ERAS-601

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 advanced 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 NSCLC.

About Erasca

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.

About MD Anderson

in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 53 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is No. 1 for cancer in U.S. News & World Report’s “Best Hospitals” rankings. It has been named one of the nation’s top two hospitals for cancer since the rankings began in 1990. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

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 and the potential patient populations for our product candidates and development programs, including ERAS-007, ERAS-601, and ERAS-4; our statements related to the product candidates, development programs and indications that will be evaluated under the MD Anderson agreement, and the benefits to be derived from the MD Anderson agreement; and the planned advancement of our development pipeline, including the clinical development plans for the HERKULES series of trials and the FLAGSHP-1 trial. 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.

Contact:

Joyce Allaire

LifeSci Advisors, LLC

Clayton Boldt, Ph.D.

MD Anderson

Source: Erasca, Inc. and The University of Texas MD Anderson Cancer Center