Nepidermin

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.

NEWTON SQUARE, Pa., May 16, 2024 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc., a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced the appointment of John Hohneker, M.D. to its Board of Directors. Dr. Hohneker brings over 30 years of experience in biopharmaceutical leadership and drug development, and currently serves on the Boards of public companies Carisma Therapeutics, Inc. and Curis, Inc., and private companies Sonata Therapeutics and Trishula Therapeutics. “We are excited to welcome Dr. Hohneker to our Board of Directors and look forward to his partnership as we work to advance our pipeline, including our lead candidate firmonertinib, and address the unmet needs of cancer patients,” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. “Dr. Hohneker brings significant medical affairs, drug development and strong market launch experience that will support the continued development of our differentiated programs.” “I am thrilled to join the ArriVent Board of Directors, not only due to the company’s strong pipeline momentum, but because of the team’s passion for providing patients with potentially transformative medicines,” said Dr. Hohneker. “I have dedicated my career to addressing the unmet needs of patients, and I look forward to continuing that work with ArriVent.” Most recently, Dr. Hohneker served as President and Chief Executive Officer of Anokion SA. Prior to this role, Dr. Hohneker was President of Research and Development at Forma Therapeutics, Inc., where he guided the company’s transition from a discovery-stage biotech to a clinical-stage company. Previously, Dr. Hohneker held various leadership roles during his 14 years at Novartis AG, including Senior Vice President and Global Head of Development, Immunology and Dermatology. During his tenure at Novartis, he played a key role in the development, approval and commercialization of several products. Dr. Hohneker earned his B.A. in chemistry from Gettysburg College and his M.D. from the University of Medicine and Dentistry of New Jersey at Rutgers Medical School. About ArriVent ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. About FirmonertinibFirmonertinib (formerly furmonertinib) is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations. In October 2023, firmonertinib was granted U.S. Food and Drug Administration Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 1b study evaluating firmonertinib in patients EGFR PACC mutations (FURTHER; NCT05364043). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with InnoCare Pharma. About EGFR mutant NSCLCGlobally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need. Forward-Looking StatementsThis press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding ArriVent’s ability to develop drugs that help to address the unmet needs of cancer patients, the timing, progress and results of pre-clinical studies and clinical trials for firmonertinib, including our product development plans and strategies, ArriVent’s clinical programs, future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in ArriVent’s annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on March 28, 2024, and its other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law. Contact for Investors & Media:Argot Partners212.600.1902ArriVent@argotpartners.com