Immunome, Inc. (IMNM) Monday reported positive data from its pivotal Phase-3 RINGSIDE trial, in patients with desmoid tumors, with Varegacestat improving progression-free survival and meeting all key secondary endpoints.
Desmoid tumors are rare, locally aggressive soft tissue neoplasms that, while non-metastatic, can cause significant morbidity. Current treatment options remain limited, highlighting the need for targeted therapies.
Varegacestat is an investigational, oral, once-daily gamma secretase inhibitor.
The RINGSIDE trial enrolled 156 patients aged 12 and older with progressive desmoid tumors in a randomized, double-blind, placebo-controlled design. Treatment with Varegacestat reduced the risk of disease progression or death by 84%. The confirmed objective response rate was 56% with Varegacestat compared to 9% with placebo. Median best change in tumor volume was -83% with Varegacestat versus +11% with placebo. Patients also reported significant improvements in pain intensity.
Varegacestat was generally well tolerated. Based on these results, Immunome plans to submit a New Drug Application to the U.S. FDA in the second quarter of 2026.
"RINGSIDE is the largest and most comprehensive clinical trial conducted to date in patients with desmoid tumors, underscoring the significance of the results," said Immunome's CEO Clay Siegall. The company plans to share additional data from the RINGSIDE trial at an upcoming major medical conference.
Beyond Varegacestat, Immunome's pipeline is advancing multiple first-in-class targeted oncology programs:
•IM-1021, a ROR1-targeted antibody-drug conjugate (ADC) incorporating Immunome's proprietary HC74 payload, is in Phase I with initial lymphoma data expected in 2026.
•IM-3050, a FAP-targeted radiotherapy that recently received IND clearance, with a Phase 1 study planned for early 2026.
•HC74 payload, a novel topoisomerase I inhibitor designed to overcome multi-drug resistance. Preclinical data demonstrated efficacy in colorectal cancer refractory to trastuzumab-DXd, NSCLC with heterogeneous target expression, and other resistant tumor models.
•The company is also advancing a portfolio of HC74-based ADCs - IM-1617, IM-1340, and IM-1335 against undisclosed solid tumor targets, currently progressing towards IND submission.
The company ended September 30, 2025, with cash of $272.6 million, providing runway into 2027.
IMNM has traded between $5.15 and $20.80 over the past year. The stock is currently trading in the pre-market at $25 up 27.75%.
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