FDA clears IND application for ERAS-4001 for the treatment of patients with KRAS-mutant (KRASm) solid tumors
“Our RAS-targeting franchise continues to meaningfully advance, and now with clearance of our IND for ERAS-4001, we are excited to advance both ERAS-4001 and ERAS-0015 into the clinic ahead of our guidance,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “ERAS-4001 targets multiple KRAS mutations as well as wildtype KRAS but spares HRAS and NRAS, potentially enabling a better therapeutic window relative to pan-RAS inhibitors. We believe these attributes offer a differentiated approach that can overcome treatment resistance to pan-RAS and mutant-selective KRAS inhibitors and address unmet needs for the 2.2 million people diagnosed annually worldwide with KRASm tumors. We look forward to continued efficient execution across our RAS-targeting programs and anticipate disclosing initial monotherapy data in 2026.”
Share:
More News
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data