ERAS-601

Erasca has cut three clinical programmes and fired 18% of its workforce. Image Credit: Andrii Yalanskyi / Shutterstock. Erasca has announced a shakeup of its clinical pipeline, shutting down three clinical programmes and licensing two cancer therapies from Joyo Pharmatech and Medshine Discovery. The company has paid $12.5m upfront to China-based Joyo for global rights, excluding mainland China, Hong Kong, and Macau, to a pan-RAS molecular glue therapy, ERAS-0015. Joyo will also be entitled to receive up to $176.5m in milestone-based payments along with royalties on sales. Erasca also has the option to gain licensing rights to Joyo territories by making a one-time payment. The company can exercise the election either before the dosing of the first patient in a Phase II clinical trial or at the time of the filing of a New Drug Application (NDA) or its foreign equivalent, by either Erasca or Joyo. A Phase I AURORAS-1 trial evaluating ERAS-0015 as a treatment for solid tumours with Ras mutations is slated to start in 2026. The investigational new drug (IND) filing is expected in the first half of next year. Molecular glue therapies have become an area of interest for developing therapies to treat cancers and rare diseases. This therapeutic approach has also driven high-value deals, with Novo Nordisk spending up to $1.46bn as part of a collaboration and licensing agreement with Neomorph to discover and develop multiple molecular glue degraders for cardiometabolic disorders and rare diseases. See Also: ERAS-601 by Erasca for Solid Tumor: Likelihood of Approval Patient access to medicines must be the focus of US drug pricing policy Erasca is also betting on a pan-KRAS inhibitor, ERAS-4001, from Medshine. The US-based company will pay $10m upfront and up to $160m in milestone-based payments, along with royalties on sales, for the exclusive worldwide licence to develop and commercialise ERAS-4001. The Phase I BOREALIS-1 trial for ERAS-4001 in KRAS mutated solid tumours has an expected start date in 2026, with IND filing expected in Q1 next year. Erasca had an internal pan-KRAS program, ERAS-4, which it will discontinue. This programme termination is contingent on certain existing ERAS-4 molecules being included as “potential backup compounds” for ERAS-4001, as part of the Medshine agreement. The two other clinical programmes that Erasca plans to discontinue include ERAS-007, an ERK inhibitor that failed to show efficacy in a Phase I/II trial to support further development, and ERAS-801, an epidermal growth factor receptor (EGFR) inhibitor. Still, the company stated that it plans to explore advancing ERAS-801 through investigator-sponsored trials. The pipeline shuffle was also accompanied by a workforce reduction of approximately 18%. Erasca added that redundant staff primarily worked in drug discovery and deprioritised programmes. The one candidate Erasca is keeping is a pan-RAF inhibitor, naporafenib. The company is evaluating the therapy in Phase I and III trials (NCT05907304 and NCT06346067) in combination with Novartis ’ mitogen-activated protein kinase (MEK) inhibitor trametinib.

Oral presentation will feature updated HERKULES-3 results for ERK1/2 inhibitor ERAS-007 in combination with encorafenib and cetuximab in BRAFm colorectal cancer Poster presentations will feature SEACRAFT-1 Phase 1 trial design for naporafenib plus trametinib in RAS Q61X mutations, and preliminary FLAGSHP-1 Phase 1 results for ERAS-601 and cetuximab in chordoma SAN DIEGO, April 24, 2024 (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 the company will present one oral presentation and two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4, 2024, in Chicago, Illinois. The abstracts will be available on the ASCO meeting website. The posters will be available online at Erasca.com/events/presentations following the presentations. Presentation Details Abstract 3517 - Updated results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with EC-naïve metastatic BRAF V600E colorectal cancer (CRC) in the phase 1b/2 HERKULES-3 studyDate/Time: Monday, June 3, 2024, 1:15 PM-2:45 PM CDTType: Rapid Oral AbstractSession: Gastrointestinal Cancer—Colorectal and AnalPresenter: Dr. Aparna Parikh, Massachusetts General HospitalLocation: McCormick Place Convention Center, Arie Crown Theater Abstract TPS3178 - An open-label study to assess the safety and efficacy of naporafenib (ERAS-254) administered with trametinib in previously treated patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations (SEACRAFT-1)Date/Time: Saturday, June 1, 2024, 9:00 AM-12:00 PM CDTType: Poster SessionSession: Developmental Therapeutics—Molecularly Targeted Agents and Tumor BiologyPresenter: Dr. Alex Spira, Next Oncology VirginiaLocation: McCormick Place Convention Center, Exhibit Hall/Hall A, Poster Board 314a Abstract 11522 – Preliminary results from FLAGSHP-1: A phase 1 study of ERAS-601 as a monotherapy or in combination with cetuximab in patients (pts) previously treated for advanced chordomaDate/Time: Saturday, June 1, 2024, 1:30 PM-4:30 PM CDTType: Poster SessionSession: SarcomaPresenter: Dr. Mrinal Gounder, Memorial Sloan Kettering Cancer CenterLocation: McCormick Place Convention Center, Exhibit Hall/Hall A, Poster Board 448 About ErascaAt Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer. Cautionary Note Regarding Forward-Looking Statements Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates, including ERAS-007, naporafenib, and ERAS-601. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; preliminary results of clinical trials are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and more patient data become available; our assumptions around which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; potential delays in the commencement, enrollment, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; the inability to realize any benefits from our current licenses, acquisitions, and collaborations, and any future licenses, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; later developments with the FDA or EU health authorities may be inconsistent with the feedback received to date regarding our development plans and trial designs; FTD may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Joyce AllaireLifeSci Advisors, LLCjallaire@lifesciadvisors.com Source: Erasca, Inc.