Erasca announces IND clearance, prioritizing of RAS-targeting franchise

Erasca (ERAS) announced clearance of an investigational new drug application by the United States Food and Drug Administration for ERAS-0015, a pan-RAS molecular glue with best-in-class potential for patients with RAS-mutant solid tumors, and submission of an IND application for ERAS-4001, a potential first-in-class pan-KRAS inhibitor in KRAS-mutant solid tumors. The company also announced a strategic decision to pursue partnership opportunities for naporafenib, enabling a meaningful extension of cash runway guidance from the second half of 2027 to the second half of 2028. RAS-Targeting Franchise Advancing to Clinic: ERAS-0015 – Potential Best-in-Class Pan-RAS Molecular Glue: IND application cleared by the FDA; Initial AURORAS-1 Phase 1 monotherapy data in RASm solid tumors expected in 2026; Potential to address unmet medical needs in approximately 2.7 million patients who are diagnosed annually worldwide with RASm tumors. ERAS-4001: Potential First-in-Class Pan-KRAS inhibitor: IND application submitted to the FDA; Initial BOREALIS-1 Phase 1 monotherapy data in KRASm solid tumors expected in 2026; Potential to address unmet medical needs in over 2.2 million patients who are diagnosed annually worldwide with KRASm tumors. Strategic Pipeline Prioritization: After the IND clearance of ERAS-0015 and the IND filing for ERAS-4001, Erasca conducted a strategic pipeline review. Following this review, in order to prioritize organizational focus and resources to advance our differentiated RAS-targeting franchise as rapidly as possible, we have decided to evaluate potential partnership opportunities for the naporafenib program. Erasca has successfully advanced naporafenib into a pivotal global Phase 3 trial following its in-licensing in December 2022. Naporafenib is a pivotal-stage pan-RAF inhibitor with a robust data package in combination with trametinib for the treatment of patients with NRASm melanoma, a disease with no approved targeted therapies and high unmet medical need. Potential first-to-market targeted therapy in NRASm melanoma, with the opportunity to address patient needs in the post immuno-oncology setting. Compelling Phase 1 and Phase 2 efficacy data suggesting clinically meaningful extension of progression-free survival and overall survival in NRASm melanoma patients relative to historical benchmarks. Established safety and tolerability results in more than 600 patients with further improvement of tolerability achieved under Erasca’s development leadership. Global regulatory alignment supporting clear registration path, and the program has been granted FDA Fast Track Designation. High investigator enthusiasm underscoring significant clinical relevance and commercial potential. As a result of Erasca’s RAS-targeting franchise advancing into the clinic and the strategic pipeline prioritization, our corporate milestones are as follows:ERAS-0015: AURORAS-1 Phase 1 monotherapy data in RASm solid tumors expected in 2026. ERAS-4001: BOREALIS-1 Phase 1 monotherapy data in KRASm solid tumors expected in 2026