Immunome (IMNM) 44th Annual J.P. Morgan Healthcare Conference summary

Key clinical and pipeline updates

• AL102 (also referred to as varegacestat), an oral gamma-secretase inhibitor, showed strong Phase III results in desmoid tumors with a hazard ratio of 0.16, 56% objective response rate, and 83% median tumor reduction, meeting all primary and key secondary endpoints.

• NDA submission for AL102/varegacestat is planned for Q2, with some sources indicating 2026, aiming for rapid FDA review and potential approval by year-end or soon after.

• ROR1 ADC (IM-1021) demonstrated objective responses at multiple dose levels in B-cell lymphomas, with plans to expand into solid tumors and further clinical development.

• FAP-targeted radioligand (IM-3050) cleared by the FDA, will enter clinical trials soon, with Phase 1 expected in early 2026, addressing a broad range of solid tumors.

• Multiple INDs for solid tumor ADCs are targeted for this year and next, with additional INDs and clinical data readouts anticipated in 2026.

Clinical and commercial strategy

• AL102/varegacestat is positioned as a best-in-class, once-daily therapy with superior pharmacokinetics and pain relief compared to existing treatments, aiming to become the new standard of care for desmoid tumors.

• Commercial efforts focus on ease of use, adherence, and targeting 85 U.S. sarcoma centers, with a modest sales force and a launch strategy for 10,000–11,000 actively managed US patients.

• ROR1 ADC aims for high single-agent response rates to differentiate from competitors and enable potential single-arm Phase II registration.

• The ADC strategy prioritizes novel targets with compelling tumor biology and no approved ADCs, leveraging high-throughput screening and proprietary technology.

• The company maintains a strong cash position, supporting operations and commercial readiness into 2028.

Technology and pipeline innovation

• Proprietary HC74 TOP1i payload technology underpins the ADC pipeline, designed to overcome resistance, improve therapeutic index, and enhance bystander effect.

• Six solid tumor ADCs are in development, with targets undisclosed for competitive reasons; IND submissions are planned sequentially.

• FAP radioligand leverages novel design to maximize tumor targeting while minimizing kidney toxicity, with trial initiation imminent.

• The leadership team includes experienced executives with a strong track record in oncology drug development, commercialization, and capital raising.

• By year-end, up to seven drugs could be in clinical development, with significant data presentations and multiple INDs expected annually.