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Erasca Achieves Key Milestones for Naporafenib and ERAS-801 Programs and Extends Cash Runway
Gained alignment with global health authorities for pivotal Phase 3 SEACRAFT-2 trial design for naporafenib plus trametinib in NRAS mutant melanoma;
About this update from Erasca, Inc.
[{"type":"text","content":"Gained alignment with global health authorities for pivotal Phase 3 SEACRAFT-2 trial design for naporafenib plus trametinib in NRAS mutant melanoma; initiation on track for H1 2024 Completed dose escalation and identified MTD for ERAS-801, supporting enrollment of expansion cohorts in recurrent GBM Extended cash runway to H1 2026 following strategic prioritization of programs SAN DIEGO, Nov. 28, 2023 (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 program updates for pan-RAF inhibitor naporafenib and central nervous system (CNS)-penetrant EGFR inhibitor ERAS-801, as well as a strategic program prioritization that extends its projected cash runway from H2 2025 to H1 2026. “We are excited about the recent progress across key clinical programs, including the regulatory alignment with U.S. and European health authorities for our global naporafenib registrational trial which is on track to initiate in the first half of 2024, the establishment of the maximum tolerated dose (MTD) for ERAS-801 in patients with glioblastoma (GBM), and the promising preliminary activity of ERAS-007 plus encorafenib and cetuximab (EC) in EC-naïve patients with BRAF mutant colorectal cancer (CRC) presented at ASCO,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “To further maximize resources, we have strategically refined our pipeline to focus on programs with the greatest therapeutic potential for patients with high unmet needs using a data-driven approach. As such, we are deprioritizing our ERAS-601 clinical trial (FLAGSHP-1) and our preclinical ERAS-5 ULK inhibitor and ERAS-10 protein degrader programs. Importantly, this pipeline prioritization extends our cash runway into the first half of 2026 and through key milestones, including important clinical trial readouts for naporafenib, ERAS-801, and ERAS-007.” Recent Program Updates Naporafenib Plus Trametinib for Patients with NRAS mutant (NRASm) Melanoma in Pivotal SEACRAFT-2 TrialEnd of Phase 2 meetings with U.S. Food and Drug Administration (FDA) and European health authorities confirm SEACRAFT-2 Phase 3 trial design and provide clarity on registrational pathway: Enrollment of patients with high ...