Immatics Advances PRAME Cell Therapy Anzu-cel Toward 2027 Market Launch with Strong Phase 3 Enrollment
核心洞察
Immatics' lead PRAME (搜索) cell therapy anzu-cel (搜索) continues strong enrollment in the global Phase 3 SUPRAME trial for advanced melanoma (搜索), with interim and final analyses expected in 2026 and BLA submission planned for first half 2027.
The company's second-generation PRAME (搜索) cell therapy IMA203CD8 showed promising anti-tumor activity in ovarian cancer (搜索) at the ESMO-IO 2025 Congress, with major conference data presentation planned for first half 2026.
Immatics expanded its Moderna collaboration with a $5 million milestone payment in January 2026, advancing the first mRNA-based TCER product candidate into clinical development.
Immatics N.V. reported significant progress across its PRAME (搜索)-targeted cancer therapy pipeline, with its lead cell therapy anzu-cel (搜索) advancing toward potential market approval in 2027 and multiple clinical milestones achieved across its comprehensive oncology franchise.
Phase 3 SUPRAME Trial Maintains Timeline for 2027 Launch
The company's flagship anzu-cel (搜索) (anzutresgene autoleucel (搜索), formerly IMA203) continues to show strong enrollment in the global, randomized, controlled Phase 3 SUPRAME trial evaluating the therapy in patients with unresectable or metastatic cutaneous melanoma (搜索) who have received prior PD-1 (搜索) immune checkpoint inhibitor treatment. The trial's primary endpoint is blinded independent central review-assessed progression-free survival, with secondary endpoints including overall survival, objective response rate, safety and patient-reported quality of life outcomes.
"Following a year of strong execution and data updates across our entire PRAME (搜索) franchise, Immatics is entering 2026 with multiple high-impact milestones ahead, including advancing our PRAME cell therapy, anzu-cel (搜索), towards approval," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics.
The SUPRAME trial timelines remain unchanged, with interim and final analyses expected to be triggered in 2026 based on the current strong enrollment rate. The company continues to expect BLA submission in the first half of 2027 and commercial launch of anzu-cel (搜索) in the second half of 2027. Patient recruitment is ongoing in North America and Europe.
Anzu-cel (搜索) has received both Orphan Drug Designation and RMAT designation from the FDA for treatment of both cutaneous and uveal melanoma (搜索). The current addressable patient population for anzu-cel's first target indications includes approximately 9,000 patients with second-line or later advanced cutaneous melanoma (搜索) as well as metastatic uveal melanoma.
Second-Generation Therapy Shows Promise in Gynecologic Cancers
Immatics' second-generation PRAME (搜索) cell therapy, IMA203CD8, demonstrated manageable tolerability and promising initial anti-tumor activity in PRAME-positive tumors at the ESMO-IO 2025 Congress. The updated Phase 1a dose escalation data included proof-of-concept data in ovarian carcinoma, with results potentially supporting positioning of IMA203CD8 to treat patients with PRAME cancers without post-infusion IL-2.
The company plans to present Phase 1a data with a focus on ovarian cancer (搜索) at relevant doses at a major medical conference in the first half of 2026. Immatics is on track to complete Phase 1a dose escalation and determine the recommended Phase 2 dose in 2026.
Bispecific Platform Advances with Combination Strategy
The company's IMA402 PRAME (搜索) bispecific achieved clinical proof-of-concept in November 2025 with updated data from the Phase 1a dose escalation trial in heavily pre-treated patients with solid tumors, including melanoma and ovarian cancer (搜索). Immatics expects to determine the final recommended Phase 2 dose and present clinical data updates from a larger patient population with focus on melanoma and gynecologic cancers (搜索) in the second half of 2026.
Based on initial promising activity of IMA401 in head and neck cancer (搜索) and squamous non-small cell lung cancer (搜索), Immatics plans to assess the synergistic potential of combining IMA402 targeting PRAME (搜索) and IMA401 targeting MAGEA4/8 (搜索). The IMA402/IMA401 combination trial in squamous non-small cell lung cancer is expected to commence in 2026.
Moderna Partnership Expansion Delivers Milestone
In December 2025, Moderna decided to advance the first mRNA-based TCER product candidate from its existing collaboration with Immatics into clinical development. This TCER, in-licensed by Moderna, is directed against an undisclosed Immatics proprietary target and is encoded in Moderna's proprietary mRNA delivery system enabling in vivo production of the TCER molecule by the patient's own body.
This expansion triggered a milestone payment of $5 million to Immatics in January 2026. Immatics will conduct the Phase 1 trial, with all associated costs fully reimbursed by Moderna. The collaboration aims to generate proof-of-principle data for in vivo production of TCER molecules, potentially supporting a broader multiplex approach targeting multiple solid tumors.
Financial Position Supports Extended Operations
Immatics reported cash and cash equivalents as well as other financial assets totaling $551.4 million as of December 31, 2025, compared to $710.3 million as of December 31, 2024. The decrease was primarily due to $234.9 million in operational cash usage for ongoing research and development activities, partially offset by net proceeds of $117.9 million from a public offering completed in December 2025. The current cash position extends the company's runway into 2028.
Total revenue for 2025 was $56.8 million, consisting of revenue from collaboration agreements, compared to $183.1 million in 2024. Research and development expenses increased to $216.0 million in 2025 from $174.0 million in 2024, reflecting advancement of product candidates in clinical trials. The company reported a net loss of $230.8 million for 2025, compared to a net profit of $17.9 million in 2024.
The company's PRAME (搜索) franchise currently includes three product candidates across two therapeutic modalities: anzu-cel (搜索) PRAME cell therapy, IMA203CD8 PRAME cell therapy, and IMA402 PRAME bispecific, along with combination therapies including anzu-cel with Moderna's PRAME cell therapy enhancer. PRAME is expressed in more than 50 cancers, positioning Immatics as the global leader in precision targeting of this oncology target.