Erasca Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Evaluate ERAS-007 and Palbociclib Combination
ERAS-007, a potential best-in-class ERK1/2 inhibitor, is being evaluated in combination with palbociclib in patients with KRAS- and NRAS-mutant colorectal cancer and KRAS-mutant pancreatic cancer
Erasca previously signed CTCSAs with Pfizer and Lilly to evaluate ERAS-007 in combination with encorafenib and cetuximab
SAN DIEGO, Oct. 20, 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 Pfizer Inc. (NYSE: PFE) for the CDK4/6 inhibitor palbociclib (IBRANCE®).
This agreement will support a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in combination with palbociclib for the treatment of patients with KRAS- and NRAS-mutant colorectal cancer (CRC) and KRAS-mutant pancreatic ductal adenocarcinoma (PDAC). The combination is currently being investigated as part of the ongoing Phase 1b/2 HERKULES-3 master protocol clinical trial in patients with gastrointestinal (GI) malignancies. Erasca is sponsoring the study, and Pfizer is supplying palbociclib at no cost.
“We are excited to expand our existing relationship with Pfizer to explore ERAS-007 in combination with palbociclib in RAS-mutated GI malignancies as part of our HERKULES-3 program,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Preclinical evidence supports synergistic anti-tumor effects when downstream RAS/MAPK pathway inhibition is combined with cell cycle inhibition in CRC and PDAC. ERAS-007 blocks RAS/MAPK pathway signaling at the terminal node with robust inhibitory activity across RAS mutations, while data support palbociclib inhibition of CDK4/6 leading to cell cycle arrest. Based on their respective mechanisms of action, ERAS-007 and palbociclib offer a promising combination to overcome adaptive resistance in patients with these highly prevalent oncogenic drivers.”
Worldwide, approximately 1.8 million cases of CRC are diagnosed annually, with about 50% of patients harboring KRAS or NRAS mutations. PDAC accounts for an estimated 0.5 million new cases diagnosed annually, with over 90% harboring a KRAS mutation. Lack of effective treatment availability and emergence of compensatory mechanisms of resistance continue to challenge the ability to achieve and maintain responses in these GI malignancies. Erasca is exploring whether inhibiting ERK1/2, the terminal node of the RAS/MAPK signaling pathway, in combination with palbociclib can limit the development of treatment resistance and further improve therapeutic benefits.
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 RAS/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 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) 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 and ERAS-601; our beliefs regarding market sizes and opportunities; the planned advancement of our development pipeline, including the clinical development plan for each of the HERKULES 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.
IBRANCE® is a registered trademark owned by or licensed to Pfizer, its subsidiaries, or affiliates.
LifeSci Advisors, LLC
Source: Erasca, Inc.