Immunome is a clinical-stage oncology company focused on developing targeted cancer therapies, primarily ADCs (antibody-drug conjugates) and related modalities, with no approved products and no product revenue. Its most advanced asset is varegacestat, an oral, once-daily gamma secretase inhibitor (GSI) for desmoid tumors — a rare soft-tissue cancer with roughly 1,000–1,650 U.S. diagnoses annually. Varegacestat completed a Phase 3 trial showing an 84% reduction in disease progression risk vs. placebo, and Immunome plans to file an NDA with the FDA in Q2 2026. If approved, Immunome plans to commercialize varegacestat directly in the U.S. through a small, targeted sales force focused on specialized oncology and sarcoma centers. Beyond varegacestat, Immunome's long-term strategy centers on its proprietary ADC platform, built around its HC74 payload — a novel topoisomerase 1 inhibitor that Immunome argues is less susceptible to drug efflux resistance and delivers a stronger bystander killing effect vs. the leading commercial DXd payload. The lead ADC, IM-1021, targets ROR1 and is in Phase 1 trials in B-cell lymphoma. Immunome also has a FAP-targeted radioligand therapy expected to enter Phase 1 in early 2026, and three preclinical ADCs targeting solid tumors. Immunome funds operations through equity raises, and carries royalty and milestone obligations to BMS and Ayala on varegacestat.
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