Immunome Wins FDA IND Clearance for IM-1340 ADC Targeting Advanced Solid Tumors

Immunome, Inc. (IMNM) said the U.S. Food and Drug Administration cleared its Investigational New Drug application for IM-1340, a first-in-class antibody-drug conjugate for advanced solid tumors, on September 30, 2026. IM-1340 targets a transport receptor with a tumor-specific expression profile across neuroendocrine tumors, lung cancer and colorectal cancer. The drug uses HC74, Immunome's proprietary topoisomerase I inhibitor payload. Preclinical studies showed anti-tumor activity across multiple tumor models. Immunome plans to begin an open-label, multicenter Phase 1 dose-escalation and expansion trial in the fourth quarter of 2026, evaluating safety, tolerability, pharmacokinetics and preliminary anti-tumor activity in patients with advanced solid tumors.