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The oncology specialist's targeted therapies could improve thousands of lives.Shares of Immunome (IMNM +15.51%) jumped over 15% on Monday after the biotech company announced positive clinical results for varegacestat, an investigational treatment for patients with progressing desmoid tumors. A destructive diseaseDesmoid tumors can be debilitating and lead to life-threatening organ damage. Each year, 1,000 to 1,650 people are diagnosed with the health condition in the U.S. alone."Desmoid tumors can have a d ...

Group 1 - U.S. stocks experienced a decline, with the Nasdaq Composite dropping over 100 points on Monday [1] - Kyverna Therapeutics Inc shares surged 31% to $11.49 following the announcement of topline data from the KYSA-8 Phase 2 trial [2][3] - The KYSA-8 trial involved mivocabtagene autoleucel (miv-cel), a CAR T-cell therapy targeting stiff person syndrome [1] Group 2 - Other notable stock gains included Beneficient, which increased by 29.3% to $6.21, and Immunome Inc, which rose 25.5% to $24.56 after positive results from its Phase 3 trial [3] - Falcon's Beyond Global Inc gained 14% to $12.83, while XBP Global Holdings Inc surged 11.5% to $6.39 [3] - Almonty Industries Inc announced a voluntary withdrawal of its base shelf prospectus, leading to a 9.1% increase in its stock price to $7.38 [3]

Pipeline Highlights - Varegacestat, an oral gamma secretase inhibitor for desmoid tumors, expects Phase 3 topline data before the end of 2025[9] - IM-1021, a ROR1 ADC, has shown objective responses in B-cell lymphoma patients at multiple dose levels[9] - IM-3050, a FAP radiotherapy, anticipates Phase 1 initiation in early 2026[9] - Three novel ADCs against solid tumor targets are undergoing IND-enabling studies to support 2026 INDs[9] HC74 Payload - HC74, a proprietary TOP1i ADC payload, is considered to have best-in-class potential[9] - HC74 demonstrates a lower efflux ratio of 10 compared to DXd's 79, potentially overcoming chemo-resistance[69] - HC74 ADC shows a payload loss of 18% at Day 7, compared to 36% for DXd ADC, indicating enhanced stability[75] Financial and Leadership - The company's cash runway is expected to extend into 2027[9] - The company's leadership team includes executives with experience at Seagen, where they grew revenue to over $2 billion in 2022, leading to a $43 billion acquisition[14] Varegacestat Market Potential - The estimated revenue for gamma secretase inhibitors (GSIs) in the US desmoid patient market is $356 million in 2025[20] - Phase 2 RINGSIDE Part A data showed a 64% response rate in the 1.2mg QD arm (n=14) and 55% overall (n=42)[27]

Pipeline Highlights - Varegacestat, an oral gamma secretase inhibitor for desmoid tumors, expects Phase 3 topline data in the second half of 2025[10] - IM-1021, a ROR1 ADC, is currently in a Phase 1 trial[10] - IM-3050, a FAP radiotherapy, anticipates Phase 1 initiation in the second half of 2025[10] - Three novel ADCs against solid tumor targets are undergoing IND-enabling studies[10] Varegacestat Clinical Data - Phase 2 RINGSIDE Part A data showed a 64% response rate in the 12mg QD arm (n=14) and 55% overall (n=42)[33] - Varegacestat demonstrated a 75% ORR by RECIST in the ITT population (n=14), compared to 41% for Nirogacestat (n=70)[32] - Varegacestat showed -88% median best tumor volume reduction in evaluable patients (n=12), compared to -59% for Nirogacestat (n=61)[32] IM-1021 Development - IM-1021 is in Phase 1 clinical trials, with the first patient dosed in 1Q25[50] - Preclinical data shows IM-1021 achieved 8/8 CR at 2.5 mg/kg in NSCLC PDX Model[58] ADC Discovery and Strategy - The company has screened ~1000 targets, evaluated 15+ targets in vivo, and has 3 novel solid tumor ADCs in IND-enabling studies[70] - Top 10 targets account for 55% of active clinical ADC programs[74]