Erasca Advances RAS-Targeting Franchise In Early Clinical Stages, Secures Over 3 Years of Cash Runway

Erasca, Inc., a clinical-stage precision oncology company focused on developing therapies for RAS/MAPK pathway-driven cancers, has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for ERAS-0015. This pan-RAS molecular glue has the potential to be a best-in-class treatment for patients with RAS-mutant (RASm) solid tumors. In addition, Erasca has submitted an IND application for ERAS-4001, a potential first-in-class pan-KRAS inhibitor aimed at treating KRAS-mutant (KRASm) solid tumors. 

This marks another significant step in the company’s mission to develop targeted therapies for cancers driven by mutations in the RAS/MAPK pathway. The company also announced its decision to seek partnership opportunities for naporafenib, a move that is expected to extend its cash runway guidance from the second half of 2027 to the second half of 2028, supporting continued research and development efforts.

Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder, said in a statement, “We are pleased to have exceeded our public guidance by advancing our RAS-targeting franchise toward the clinic following our efficient IND execution ahead of schedule. Both ERAS-0015 and ERAS-4001 have the potential to change the treatment paradigm for patients with solid tumors mutated in (K)RAS, the most prevalent oncogenic driver, which is highly enriched across colorectal, pancreatic, and non-small cell lung cancers. Our team is excited to build on this momentum to advance these promising product candidates as quickly as possible to deliver meaningful benefits to patients.”

Dr. Lim add further, “We remain confident in the strong therapeutic potential of naporafenib in NRAS-mutant (NRASm) melanoma. However, to focus our organizational efforts on our now clinical-stage RAS-targeting franchise, we are seeking a strategic partner to further develop and commercialize naporafenib and are encouraged by our ongoing discussions. We believe that the broad clinical application of these validated RAS targets, the robust excitement for our competitive candidates, and the tremendous progress we have made across both programs since their in-licensing last May strongly position us for success as we aim to help treat the millions of patients with RASm solid tumors.”

He concluded stating, “Importantly, this decision allows an extension of our cash runway guidance from the second half of 2027 to the second half of 2028. Having more than three years of cash despite no new infusion of capital in this volatile macroenvironment bolsters our ability to focus on successfully executing our ambitious clinical development plans for ERAS-0015 and ERAS-4001.”

Data from the AURORAS-1 Phase 1 monotherapy trial for ERAS-0015 in RASm solid tumors is expected to be available in 2026. This therapy has the potential to address the unmet medical needs of approximately 2.7 million patients diagnosed annually worldwide with RASm tumors. Additionally, the company has submitted an IND application for ERAS-4001, a potential first-in-class pan-KRAS inhibitor designed to treat KRAS-mutant (KRASm) solid tumors. Initial data from the BOREALIS-1 Phase 1 monotherapy trial for ERAS-4001 in KRASm solid tumors is also expected in 2026. This treatment has the potential to address the unmet needs of over 2.2 million patients diagnosed annually worldwide with KRASm tumors.

Following the IND clearance for ERAS-0015 and the IND submission for ERAS-4001, Erasca conducted a strategic pipeline review. To prioritize the advancement of its RAS-targeting franchise, the company has decided to explore potential partnership opportunities for the naporafenib program. Naporafenib, a pan-RAF inhibitor in combination with trametinib (MEKINIST®), is currently in a pivotal global Phase 3 trial for NRAS-mutant melanoma, a cancer with no approved targeted therapies and high unmet medical need. The naporafenib program has shown promising efficacy in Phase 1 and Phase 2 trials, demonstrating clinically meaningful improvements in progression-free survival and overall survival compared to historical benchmarks.

Looking ahead, Erasca has set key milestones for its pipeline. The company expects to release AURORAS-1 Phase 1 monotherapy data for ERAS-0015 in RASm solid tumors in 2026, as well as BOREALIS-1 Phase 1 monotherapy data for ERAS-4001 in KRASm solid tumors in the same year.