ERAS-4001 / Erasca, Medshine Discovery - LARVOL DELTA

BOREALIS-1: A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Erasca, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Solid Tumor

BOREALIS-1: A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - P1 | N=200 | Not yet recruiting | Sponsor: Erasca, Inc.

Monotherapy • New P1 trial • Solid Tumor

Erasca Announces IND Clearance for Potential First-in-Class and Best-in-Class Pan-KRAS Inhibitor ERAS-4001 (GlobeNewswire) - "Erasca...announced clearance of an investigational new drug (IND) application by the United States Food and Drug Administration (FDA) for ERAS-4001, a potential first-in-class and best-in-class pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant (KRASm) solid 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."

IND • New P1 trial • Solid Tumor

Erasca Announces Early Clinical Advancement and Prioritization of RAS-Targeting Franchise Coupled with More than 3 Years of Projected Cash Runway (GlobeNewswire) - "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...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."

IND • New P1 trial • Oncology • Solid Tumor

Erasca Reports First Quarter 2025 Business Updates and Financial Results (GlobeNewswire) - "Key Upcoming Milestones: (i) AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors: Initial Phase 1 monotherapy data expected in 2026; (ii) BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors: Initial Phase 1 monotherapy data expected in 2026."

P1 data • Solid Tumor

Abstract 4367 - ERAS-4001 is a pan-KRAS inhibitor with robust anti-tumor activity in KRAS altered solid tumors (GlobeNewswire) - "Erasca...presented new preclinical data reinforcing the best-in-class profiles of Erasca’s RAS-targeting franchise at the American Association for Cancer Research (AACR) Annual Meeting....ERAS-4001 inhibited 3D cell viability and proliferation in 13 G12X mutant and one wildtype KRAS amplified cell lines across indications with single digit nanomolar IC50s. Dose-dependent tumor growth inhibition and significant antitumor efficacy with ERAS-4001 monotherapy in KRAS mutant xenograft models. Robust tumor growth inhibition with ERAS-4001 plus anti-PD-1 or cetuximab in KRAS mutant models. Promising antitumor monotherapy and combination activity across multiple KRAS mutant models."

Preclinical • Solid Tumor

ERAS-4001 is a pan-KRAS inhibitor with robust anti-tumor activity in KRAS altered solid tumors (AACR 2025) - "We hypothesize that the potency and selectivity profile of the pan-KRAS inhibitor ERAS-4001 will provide efficacy and tolerability for patients with tumors driven by oncogenic KRAS alterations. An IND submission is intended for the first quarter of 2025."

Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HRAS • KRAS • NRAS

Erasca Reports Fourth Quarter and Full Year 2024 Business Updates and Financial Results (GlobeNewswire) - "AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors...IND filing expected in mid-Q2 2025...Initial Phase 1 monotherapy data in relevant tumor types expected in 2026; BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors...IND filing expected in Q2 2025...Initial Phase 1 monotherapy data in relevant tumor types expected in 2026"

New P1 trial • P1 data • Solid Tumor

Erasca Announces Three Poster Presentations at the 2025 AACR Annual Meeting (GlobeNewswire) - "Presentations will feature potential best-in-class pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001. Erasca will also present potential first-in-class examples of direct SMP complex inhibitors, representing a new approach to block the RAS/MAPK pathway."

Preclinical • Solid Tumor

Erasca Reports Third Quarter 2024 Business Updates and Financial Results (GlobeNewswire) - "Key Upcoming Milestones: (i) AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors - IND filing expected in H1 2025; Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026; (ii) BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors - IND filing expected in Q1 2025; Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026."

IND • P1 data • Solid Tumor

RAS Targeting Franchise Update (ERAS-0015 and ERAS-4001) (GlobeNewswire) - "Nonclinical data continue to support potential best-in-class profiles, including data generated in-house; In-life portion of Good Laboratory Practice (GLP) toxicology studies tracking as anticipated: ERAS-0015 completed, ERAS-4001 near completion."

Preclinical • Oncology • Solid Tumor

Erasca Reports Second Quarter 2024 Business Updates and Financial Results (GlobeNewswire) - "Key Upcoming Milestones: AURORAS-1: IND filing expected in H1 2025; Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026; BOREALIS-1: IND filing expected in Q1 2025; Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026."

IND • P1 data • Oncology • Solid Tumor

Erasca Announces Strategic In-Licensing of RAS-Targeting Franchise (GlobeNewswire) - "Erasca, Inc...announced it has entered into exclusive license agreements for two preclinical RAS programs—a potential best-in-class pan-RAS molecular glue (ERAS-0015) and a potential first-in-class pan-KRAS inhibitor (ERAS-4001)...Under the terms of the ERAS-0015 license agreement, in exchange for an exclusive license to develop and commercialize ERAS-0015 in the Erasca territory...Erasca will pay the licensor, Joyo Pharmatech Co., Ltd. (Joyo), a one-time upfront cash payment of $12.5 million...Key Upcoming Milestones...AURORAS-1: Phase 1 trial for ERAS-0015 in patients with RASm solid tumors: IND filing expected in H1 2025...BOREALIS-1: Phase 1 trial for ERAS-4001 in patients with KRASm solid tumors....Initial Phase 1 monotherapy data in relevant tumor types expected in 2026."

IND • Licensing / partnership • P1 data • Oncology • Solid Tumor