Immunome receives FDA clearance for IM-1340 solid tumor trial

Immunome Inc., a clinical-stage targeted oncology company based in Bellingham, Washington, has received approval from the U.S. Food and Drug Administration for its investigational drug IM-1340. This antibody-drug conjugate aims to treat advanced solid tumors, which include neuroendocrine tumors, lung cancer, and colorectal cancer. IM-1340 utilizes HC74, a topoisomerase I inhibitor payload developed by Immunome.

The company plans to commence a Phase 1 first-in-human study of IM-1340 in patients with advanced solid tumors in the fourth quarter of 2026. This trial will be an open-label, multicenter dose-escalation and expansion study, with the aim of assessing the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of the investigational therapy.

Clay Siegall, Immunome's President and Chief Executive Officer, expressed enthusiasm about this milestone, stating that the IND clearance for IM-1340 demonstrates the company's ability to rapidly advance novel programs into the clinic. Immunome's other investigational programs include varegacestat, an investigational gamma secretase inhibitor, IM-1021, a ROR1 ADC, IM-1617, a solid tumor ADC, and IM-3050, a FAP-targeted radiotherapy.