Immunome (NasdaqCM:IMNM) FY Conference Summary Company Overview - **Company**: Immunome - **Event**: 44th J.P. Morgan Healthcare Conference - **Date**: January 14, 2026 Core Industry Focus - **Industry**: Biotechnology, specifically in targeted oncology therapies Key Points and Arguments AL102 Development - **Drug Description**: AL102 is an oral gamma-secretase inhibitor for treating desmoid tumors, administered once daily [4][5] - **Clinical Progress**: Positive top-line data reported in December, with plans to submit a New Drug Application (NDA) in Q2 2026 [5][8] - **Efficacy Data**: - Hazard ratio of 0.16, indicating strong efficacy [8] - Objective response rate of 56% based on strict FDA criteria [8][16] - Median tumor reduction of 83% [8][16] - **Patient Population**: Approximately 10,000-11,000 patients in the U.S. actively managed for desmoid tumors annually [10][17] Competitive Landscape - **Comparison with Nirogacestat**: AL102 is positioned as a better option due to superior pharmacokinetics and a more user-friendly dosing schedule [11][12][47] - **Historical Context**: Previous treatments had lower response rates (20% pre-2018, 33% with Sorafenib in 2018, and 41% with Nirogacestat in 2023) [16] ADC Program - **ROR1 ADC (IM-1021)**: - Focus on liquid tumors, particularly B-cell lymphomas [22][26] - Development of a diagnostic tool for ROR1 to enhance treatment targeting [22] - Objective responses observed in early trials, with plans for further expansion [23][26] - **HC74 Platform**: A new ADC technology that improves therapeutic index and overcomes resistance mechanisms [27][30] Radioligand Development - **FAP Targeting**: A radioligand targeting fibroblast activation protein (FAP), which binds to 75% of solid tumors [35][36] - **Clinical Trials**: FDA clearance obtained, with trials expected to start soon [36][39] Financial Position - **Cash Position**: Sufficient funding to extend operations into 2028 [6] Future Outlook - **Upcoming Submissions**: Plans to submit three INDs for solid tumor ADCs and the FAP radioligand within the year [39][64] - **Investor Expectations**: Anticipation of FDA approval for AL102 and significant clinical data releases by the end of 2026 [63][64] Additional Important Information - **Safety Profile**: AL102 has a generally well-tolerated safety profile, with common adverse events being manageable [15] - **Market Strategy**: Focus on making AL102 accessible to the 10-11,000 patients actively managed for desmoid tumors, leveraging a modest sales force [18] This summary encapsulates the critical insights from the Immunome conference, highlighting the company's innovative approaches in oncology and its strategic positioning in the biotechnology sector.

Core Insights - New data from the ALPHAMEDIX-02 phase 2 study supports the first-in-class potential of AlphaMedix (212Pb-DOTAMTATE) for treating advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [1][5][10] - The study demonstrated significant efficacy in both radioligand therapy (RLT)-naïve and RLT-exposed patients, indicating its potential to address unmet medical needs in this challenging cancer type [2][5][10] Study Overview - ALPHAMEDIX-02 is a phase 2, open-label, multicenter study assessing the efficacy and safety of AlphaMedix in patients with unresectable or metastatic SSTR+ GEP-NETs, including cohorts for RLT-naïve and RLT-exposed patients [3][12] - The primary efficacy endpoint was the overall response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS) [3][12] Efficacy Results - In the RLT-naïve cohort (n=35), the ORR was 60.0% per investigator assessment and 57.1% per independent assessment, with a disease control rate (DCR) of 94.3% [4][6] - In the RLT-exposed cohort (n=26), the ORR was 34.6% per investigator assessment and 19.2% per independent assessment, with a DCR of 96.2% [6] - The 36-month PFS rate for RLT-naïve patients was 72.3%, while the 18-month PFS rate for RLT-exposed patients was 82.6% [6] Safety Profile - AlphaMedix exhibited a similar safety profile across both cohorts, with 85.7% of RLT-naïve patients and 84.6% of RLT-exposed patients completing all four doses [6][10] - Treatment-emergent adverse events (TEAEs) were reported in all patients, with grade ≥3 TEAEs occurring in 42.3% of RLT-exposed and 54.3% of RLT-naïve patients, primarily involving lymphocyte count decrease [6][10] Future Development - The positive results from the ALPHAMEDIX-02 study will inform further discussions with health authorities and support the planning of an international phase 3 study [10][11] - Sanofi has entered an exclusive licensing agreement with Orano Med and RadioMedix to globally commercialize AlphaMedix, indicating strong commercial interest and potential market impact [11]