Immunome Prepares to Release Phase 3 RINGSIDE Trial Results for Varegacestat in Desmoid Tumors
核心洞察
Immunome is scheduled to announce topline Phase 3 RINGSIDE trial results for varegacestat, an oral gamma secretase (搜索) inhibitor, in patients with progressive desmoid tumors (搜索) on December 15, 2025.
The placebo-controlled trial enrolled 156 patients aged 12 and older with progressive desmoid tumors (搜索), addressing a significant unmet medical need in rare, locally aggressive soft tissue neoplasms.
Beyond varegacestat, Immunome's pipeline includes multiple first-in-class oncology programs, including ROR1-targeted ADC IM-1021 and FAP (搜索)-targeted radiotherapy IM-3050.
Immunome, Inc. (Nasdaq: IMNM) is set to announce topline results from its pivotal Phase 3 RINGSIDE trial evaluating varegacestat in patients with progressive desmoid tumors (搜索) during a conference call and webcast scheduled for Monday, December 15, 2025, at 8:30 a.m. ET.
Trial Design and Patient Population
The RINGSIDE trial is a placebo-controlled Phase 3 study that enrolled 156 patients aged 12 and older with progressive desmoid tumors (搜索). Varegacestat is an investigational, oral, once-daily gamma secretase (搜索) inhibitor designed to target a key enzyme implicated in the pathogenesis of desmoid tumors.
Addressing Unmet Medical Need
Desmoid tumors (搜索) represent rare, locally aggressive soft tissue neoplasms that, while non-metastatic, can cause significant morbidity. Current treatment options remain limited, highlighting the critical need for targeted therapies in this patient population.
Broader Pipeline Development
Beyond varegacestat, Immunome is advancing multiple first-in-class targeted oncology programs. The company's pipeline includes IM-1021, a ROR1-targeted antibody-drug conjugate (ADC) incorporating Immunome's proprietary HC74 (搜索) payload, currently in Phase 1 with initial lymphoma (搜索) data expected in 2026.
The company recently received IND clearance for IM-3050, a FAP (搜索)-targeted radiotherapy, with a Phase 1 study planned for early 2026. Additionally, Immunome is developing HC74 (搜索) payload, a novel topoisomerase I (搜索) inhibitor designed to overcome multi-drug resistance. Preclinical data demonstrated efficacy in colorectal cancer (搜索) refractory to trastuzumab-DXd, NSCLC (搜索) with heterogeneous target expression, and other resistant tumor models.
Financial Position and Market Performance
Immunome ended September 30, 2025, with cash of $272.6 million, providing operational runway into 2027. The company's stock has traded in a range of $5.15 to $20.80 over the past year, closing Friday's trading at $19.57, up 0.41%, and rising further in overnight trading to $20.49, up 4.70%.
The company is also advancing a portfolio of HC74 (搜索)-based ADCs - IM-1617, IM-1340, and IM-1335 against undisclosed solid tumor targets, which are currently progressing towards IND submission.
Conference Call Details
The live webcast will include presentation slides and can be accessed through the Events and Presentations section of the Immunome website. A live question-and-answer session will follow the prepared remarks, with participants required to join via conference call to ask questions. The webcast will remain archived on the company's website for 90 days following the event.