Erasca announces IND clearance for ERAS-4001

Erasca (ERAS) announced clearance of an investigational new drug application by the FDA for ERAS-4001, a potential first-in-class and best-in-class pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant solid tumors. “Our RAS-targeting franchise continues to meaningfully advance, and now with clearance of our IND for ERAS-4001, we are excited to advance both ERAS-4001 and ERAS-0015 into the clinic ahead of our guidance,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “ERAS-4001 targets multiple KRAS mutations as well as wildtype KRAS but spares HRAS and NRAS, potentially enabling a better therapeutic window relative to pan-RAS inhibitors. We believe these attributes offer a differentiated approach that can overcome treatment resistance to pan-RAS and mutant-selective KRAS inhibitors and address unmet needs for the 2.2 million people diagnosed annually worldwide with KRASm tumors. We look forward to continued efficient execution across our RAS-targeting programs and anticipate disclosing initial monotherapy data in 2026.” The BOREALIS-1 Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ERAS-4001 in patients with KRASm solid tumors. Erasca is also advancing ERAS-0015, a potential best-in-class pan-RAS molecular glue, which is being evaluated in the AURORAS-1 Phase 1 trial for the treatment of patients with RAS-mutant solid tumors.