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Erasca Announces FDA Clearance of IND Application for CNS-Penetrant KRAS G12C Inhibitor ERAS-3490 in KRAS G12C-Mutated Advanced or Metastatic Solid Tumors
ERAS-3490, an orally available small molecule KRAS G12C inhibitor, has demonstrated robust nonclinical CNS and systemic activity SAN DIEGO, Dec. 13, 2022
About this update from Erasca, Inc.
[{"type":"text","content":"ERAS-3490, an orally available small molecule KRAS G12C inhibitor, has demonstrated robust nonclinical CNS and systemic activity\nSAN DIEGO, Dec. 13, 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 the United States Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for ERAS-3490, an orally available small molecule KRAS G12C inhibitor designed to have high central nervous system (CNS) penetration for the treatment of KRAS G12C-mutated solid tumors, including non-small cell lung cancer (NSCLC). “KRAS G12C is a prevalent oncogenic mutation that was historically considered undruggable. While first generation inhibitors have made great progress against this mutation, we believe that they do not sufficiently penetrate the blood-brain barrier which can lead to poor disease control, particularly in NSCLC, where up to 40% of patients may develop CNS metastases,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “ERAS-3490, our first homegrown development candidate, was selected for its robust CNS and systemic activity. We are pleased the FDA has cleared our IND for ERAS-3490.” In April, Erasca presented nonclinical data for ERAS-3490 at the American Association for Cancer Research (AACR) Annual Meeting showing robust anti-tumor activity in KRAS G12C mutant MIA PaCa-2, NCI-H1373, and NCI-H2122 CDX subcutaneous models. ERAS-3490 also demonstrated robust anti-tumor activity and dose-dependent survival benefit in the KRAS G12C NSCLC intracranial model NCI-H1373-luc, a nonclinical model of NSCLC CNS metastases. About ErascaAt 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...