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Immatics Achieves Clinical Proof-of-Concept of its Next-Generation TCR Bispecific (TCER®) Pipeline with Data on IMA402 (PRAME) and IMA401 (MAGEA4/8) and Announces Next Development Steps
Globenewswire· 2025-11-12 12:00
Core Insights - Immatics N.V. announced updated Phase 1a dose escalation data for its TCR Bispecifics pipeline, specifically IMA402 PRAME Bispecific and IMA401 MAGEA4/8 Bispecific, highlighting their potential in treating advanced metastatic solid tumors with limited treatment options [1][2][3] Summary by Sections Clinical Development - The company has achieved clinical proof-of-concept for both IMA402 and IMA401, indicating their potential to provide meaningful benefits to patients with limited treatment options [2] - IMA402 is advancing into Phase 1b dose expansion, focusing on melanoma and gynecologic cancers, with plans to explore combinations with immune checkpoint inhibitors [11] - IMA401 is also being evaluated for its clinical activity in combination with IMA402, particularly in squamous non-small cell lung cancer (sqNSCLC) [18] Efficacy Data - IMA402 demonstrated a confirmed objective response rate (cORR) of 30% (6/20) across all indications, with specific rates of 29% (4/14) in melanoma and 66.7% (2/3) in ovarian carcinoma [4][10] - IMA401 showed a cORR of 25% (2/8) in head and neck cancer and 29% (2/7) in melanoma, with promising activity in sqNSCLC [20] Safety Profile - IMA402 exhibited favorable tolerability, with the most common treatment-related adverse events being transient lymphopenia and low-grade cytokine release syndrome [5][6] - IMA401 also showed a favorable safety profile, with low-grade cytokine release syndrome and manageable lymphopenia observed [15][16] Patient Population - IMA402 was tested on 80 heavily pre-treated patients with advanced metastatic solid tumors, while IMA401 was evaluated in 55 heavily pre-treated patients across various tumor types [3][14] Future Directions - The company plans to initiate additional Phase 1b cohorts in 2026 to explore the monotherapy and combination potential of IMA402 and IMA401 [11][18] - The addressable patient population for metastatic sqNSCLC in the US and EU5 is estimated at 40,000 patients per year, indicating significant market potential [18]