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Erasca Announces First Patient Dosed in HERKULES-2 Phase 1b/2 Lung Cancer Master Protocol Evaluating ERAS-007 in Multiple Combinations
[September 09, 2021]

Erasca Announces First Patient Dosed in HERKULES-2 Phase 1b/2 Lung Cancer Master Protocol Evaluating ERAS-007 in Multiple Combinations


SAN DIEGO, Sept. 09, 2021 (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 dosing of the first patient in the HERKULES-2 Phase 1b/2 trial evaluating ERAS-007 in combination with various agents in patients with advanced non-small cell lung cancer (NSCLC).

“As the foundation of Erasca’s lung cancer platform, HERKULES-2 is a master protocol designed to inhibit multiple oncogenic drivers of the RAS/MAPK pathway to address high unmet needs in lung cancer. Initially focused on patients with mutant EGFR or KRAS NSCLC, HERKULES-2 will further progress to evaluate other combinations targeting additional subtypes of NSCLC,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Erasca’s series of HERKULES trials also includes tissue-specific master protocols in gastrointestinal cancers and hematological malignancies as well as a tissue-agnostic trial, tailored to evaluate promising combinations to inhibit oncogenic signaling and prevent the emergence of resistance.”

HERKULES-2 will initially examine the safety, tolerability, and preliminary efficacy of ERAS-007 in combination with osimertinib (TAGRISSO®) in patients with advanced NSCLC harboring an epidermal growth factor receptor mutation (EGFRm). After a recommended dose is determined, the Phase 2 expansion portion will further evaluate the safety and efficacy of the combination in patients whose disease has developed resistance to osimertinib, a setting in which there are currently no approved targeted therapies. Future sub-studies of HERKULES-2 will explore ERAS-007 or the SHP2 inhibitor ERAS-601 in combination with other agents in patients with different mutational subtypes, including a KRAS G12C mutation.

ERAS-007, a potential best-in-class inhibitor of the extracellular signal-regulated kinases (ERK), targets the terminal node of the RAS/MAPK pathway. The broad applicability of ERAS-007 across a wide range of indications and tumor types was recently highlighted in a preclinical study published in Cell Reports Medicine, supporting durable ERK blockade and potent antiproliferative efficacy in both solid tumor an hematological malignancy cell lines. ERAS-007 demonstrated preferential anti-tumor activity for tumor types harboring mutant BRAF, KRAS, NRAS, or HRAS, as well as robust inhibitory activity across a range of mutant KRAS subtypes.



About ERAS-007
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. The broad therapeutic potential of ERAS-007 is being investigated initially across four 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, 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, and HERKULES-2, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with NSCLC, are currently enrolling patients. HERKULES-3, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers, is expected to begin by year-end. HERKULES-4, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies, is anticipated to begin in the first quarter of 2022.

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.


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 and ERAS-601; and the planned advancement of our development pipeline, including the clinical development plans and anticipated trial start dates for each of the HERKULES series of trials. 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; 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 quarterly report on Form 10-Q 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
jallaire@lifesciadvisors.com


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