Immunome Announces Pipeline Advancements, Including Phase 3 Data and Novel ADC Programs
核心洞察
Immunome anticipates topline data from the Phase 3 RINGSIDE trial of varegacestat for desmoid tumors (搜索) in the second half of 2025, marking a key milestone.
The FDA has cleared the IND for IM-1021, a ROR1-targeted antibody-drug conjugate (ADC), paving the way for clinical trials.
Immunome is progressing three novel ADC programs—IM-1617, IM-1340, and IM-1335—for solid tumor indications through preclinical development.
Immunome, Inc. (Nasdaq: IMNM) has provided an update on its advancing pipeline of targeted cancer therapies, including progress on varegacestat, an active IND for IM-1021, and novel ADC programs. Clay Siegall, Ph.D., President and CEO of Immunome, presented these updates at the 43rd Annual J.P. Morgan Healthcare Conference.
Varegacestat Phase 3 Trial
Varegacestat (formerly known as AL102), a once-daily oral gamma secretase inhibitor, is currently in the Phase 3 RINGSIDE clinical trial for the treatment of desmoid tumors (搜索). Topline data from this trial is expected in the second half of 2025. Desmoid tumors are rare, locally aggressive soft tissue tumors that can cause significant morbidity. There remains an unmet need for effective therapies, as current treatment options are limited and can have substantial side effects.
IM-1021 IND Clearance
The FDA has cleared the Investigational New Drug (IND) application for IM-1021, a ROR1-targeted antibody-drug conjugate (ADC). This clearance allows Immunome to proceed with clinical trials for IM-1021. ROR1 is an attractive target for cancer therapy due to its overexpression in various hematological malignancies and solid tumors, while having limited expression in normal adult tissues.
Novel ADC Programs
Immunome is also developing three novel ADC programs targeting solid tumors: IM-1617, IM-1340, and IM-1335. These programs are currently in preclinical development, with undisclosed targets expressed in multiple solid tumors. The advancement of these programs underscores Immunome's commitment to expanding its portfolio of targeted cancer therapies.
IM-3050 Radioligand Therapy
An IND submission for IM-3050, a FAP (搜索)-targeted radioligand therapy, is anticipated by the end of the first quarter of 2025. FAP (fibroblast activation protein) is highly expressed in the tumor microenvironment of many cancers, making it a promising target for radioligand therapy. This submission will mark another step in expanding Immunome's therapeutic approaches.
Immunome is a clinical-stage targeted oncology company focused on developing first- and best-in-class therapies to improve outcomes for cancer patients. The company's pipeline includes varegacestat, IM-1021, IM-3050, IM-1617, IM-1335, and IM-1340.