Core Insights - Immatics N.V. announced updated Phase 1a dose escalation data for its second-generation PRAME cell therapy, IMA203CD8, targeting difficult-to-treat solid tumors expressing PRAME, including ovarian cancer [1][3][4] Patient Population - The ongoing Phase 1a trial enrolled 78 heavily pre-treated patients with advanced solid tumors expressing PRAME, with a median of three prior systemic treatments [4] - The efficacy-evaluable population included 69 patients, comprising 42 with melanoma, 11 with ovarian carcinoma, 11 with synovial sarcoma, and 5 with other tumor types [4] Safety Profile - IMA203CD8 demonstrated manageable tolerability, with the most common treatment-emergent adverse events being cytopenias associated with lymphodepletion [5][7] - Cytokine release syndrome (CRS) was mostly Grade 1 to 2, with Grade 1 at 35%, Grade 2 at 50%, Grade 3 at 9%, and Grade 4 at 1% [5] Anti-Tumor Activity - Initial results showed deep and durable objective responses in PRAME-positive advanced solid tumors, with a one-time infusion of IMA203CD8 leading to a 36% confirmed objective response rate (cORR) and a 46% overall response rate (ORR) [10][12] - In patients with ovarian carcinoma, a promising dose-dependent signal was observed, with two confirmed partial responses and one ongoing metabolic complete response at the highest dose level [11] Clinical Development - The company aims to complete the Phase 1a dose escalation and determine the recommended Phase 2 dose (RP2D) by 2026, including data on the two highest dose levels [15] - IMA203CD8 is positioned to target advanced PRAME cancers beyond melanoma, starting with gynecologic cancers, and may not require post-infusion low-dose IL-2 in the future [14][16] Company Overview - Immatics is a leader in precision targeting of PRAME, with a broad franchise that includes multiple product candidates and therapeutic modalities targeting PRAME across various cancers [17][18]

Core Insights - Immatics N.V. announced updated data from a Phase 1b trial of anzu-cel PRAME cell therapy for patients with metastatic uveal melanoma, highlighting its potential to improve treatment outcomes in this challenging patient population [1][3][4] Patient Population - The trial involved 16 patients with metastatic uveal melanoma, who received a one-time infusion of anzu-cel at a recommended Phase 2 dose of 1 to 10 billion total TCR T cells, with a median infused dose of approximately 4 billion TCR T cells [4][5] - Patients had a median of 2 lines of prior systemic treatments and a median target lesion sum diameter of 103 mm, with 81% having liver and extrahepatic metastasis [4] Anti-tumor Activity and Durability - The updated data showed a confirmed objective response rate (cORR) of 67% (10 out of 15 patients) and a disease control rate (DCR) of 88% (14 out of 16 patients) [6] - The median duration of response (mDOR) was 11 months, with a median progression-free survival (mPFS) of 8.5 months, and median overall survival (mOS) not reached at 14.3 months of follow-up [6][5] - Anti-tumor activity was observed across various metastases, including liver lesions, with a median shrinkage of 49.6% in liver target lesions [7][5] Safety Profile - Anzu-cel demonstrated a favorable tolerability profile, consistent with its overall safety profile, with the most frequent treatment-emergent adverse events being cytopenias associated with lymphodepletion [9][12] - Cytokine release syndrome (CRS) was mostly Grade 1 or 2, with no long-term CRS observed, and most cases resolved by day 14 [12][9] Development Path - Based on the promising clinical data, Immatics has initiated a Phase 2 cohort with approximately 30 patients planned, conducted at select centers in the U.S. and Germany [14] - Prospective PRAME testing is no longer required for inclusion in the clinical trial due to the high prevalence of PRAME expression in uveal melanoma [14] Company Overview - Immatics is a clinical-stage biopharmaceutical company focused on precision targeting of PRAME, with a broad pipeline that includes multiple product candidates and therapeutic modalities [16][18] - Anzu-cel is part of a larger strategy to develop therapies for various cancers expressing PRAME, with ongoing trials in both uveal and cutaneous melanoma [17][15]