This section highlights FDA-related milestones and regulatory updates for drugs developed by Immatics (IMTX).
Over the past two years, Immatics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ACTengine, IMA203CD8, and IMA401. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ACTengine (IMA203) - FDA Regulatory Timeline and Events
ACTengine (IMA203) is a drug developed by Immatics for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ACTengine (IMA203)
- Announced Date:
- March 27, 2025
- Indication:
- Solid tumors
Announcement
Immatics N.V. provided a business update
AI Summary
Immatics N.V. provided a business update and shared its financial results for the quarter and full year ended December 31, 2024. The company highlighted significant progress with its clinical portfolio, focusing on its lead TCR-T therapy, IMA203. In the Phase 3 SUPRAME trial for advanced melanoma, the first patient has already been randomized and patient enrollment is running as planned across sites in the United States and Europe. CEO Harpreet Singh emphasized that 2025 will bring important data milestones, including updates from trials in ovarian cancer and head and neck cancer. In addition to IMA203, Immatics is advancing next-generation therapy candidates like IMA203CD8 and its TCR bispecific programs, TCER® IMA402 and IMA401, as dose escalation continues. The company ended 2024 with robust financials and ample funding to support its growing clinical efforts.
Read Announcement- Drug:
- ACTengine (IMA203)
- Announced Date:
- October 10, 2024
- Indication:
- Solid tumors
Announcement
Immatics N.V. announced updated Phase 1b clinical data on ACTengine® IMA203 TCR-T targeting PRAME in melanoma patients and provided an update on SUPRAME, the upcoming Phase 3 trial to evaluate IMA203 in metastatic melanoma patients.
AI Summary
Immatics N.V. announced updated Phase 1b clinical data for its ACTengine® IMA203 TCR-T therapy targeting PRAME in patients with metastatic melanoma. The updated data shows that among heavily pretreated melanoma patients, 54% had an objective response, and some experienced durable responses with a median progression-free survival of six months. This marks a significant improvement compared to earlier data, highlighting the therapy’s potential in extending treatment benefits.
The company also provided an update on the upcoming SUPRAME Phase 3 trial, which will involve 360 patients with unresectable or metastatic melanoma who have already been treated with checkpoint inhibitors. In this trial, patients will be randomized to receive either IMA203 or the investigator's choice of approved treatments. The primary endpoint will be median progression-free survival, offering a fast pathway to seek full regulatory approval, with enrollment expected to finish by 2026.
Read Announcement
IMA203CD8 (ACTengine) - FDA Regulatory Timeline and Events
IMA203CD8 (ACTengine) is a drug developed by Immatics for the following indication: Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMA203CD8 (ACTengine)
- Announced Date:
- May 31, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Immatics N.V. announced the presentation of expanded data from the ongoing Phase 1b clinical trial evaluating IMA203 PRAME cell therapy in heavily pretreated patients with metastatic melanoma.
AI Summary
Immatics N.V. recently presented expanded data from its ongoing Phase 1b clinical trial of IMA203 PRAME cell therapy in 33 heavily pretreated patients with metastatic melanoma. The trial showed a favorable safety profile and promising clinical activity, with a confirmed objective response rate of 56% and durable responses lasting over 2.5 years. Researchers noted that the median duration of response was 12.1 months, and the therapy was well tolerated, with manageable side effects such as low-grade cytokine release syndrome and cytopenias related to lymphodepletion.
These encouraging results highlight the potential of IMA203 PRAME cell therapy for patients who have few treatment options. The data reinforce the rationale for further studying this therapy in additional trials, including the Phase 3 SUPRAME trial for advanced cutaneous melanoma. Immatics continues to build on its leadership in targeted PRAME therapies for cancer patients with high unmet medical needs.
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IMA401 - FDA Regulatory Timeline and Events
IMA401 is a drug developed by Immatics for the following indication: Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMA401
- Announced Date:
- September 16, 2024
- Indication:
- Advanced Solid Tumors
Announcement
Immatics N.V today presented the proof-of-concept clinical data for the first candidate of its next-generation, half-life extended TCR Bispecifics platform, TCER® IMA401 (MAGEA4/8), during an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024.
AI Summary
Immatics N.V. has presented proof-of-concept clinical data for its first candidate from the next-generation, half-life extended TCR Bispecifics platform, TCER® IMA401 (MAGEA4/8), at the European Society for Medical Oncology (ESMO) Congress 2024. The data come from a Phase 1 dose escalation trial in heavily pretreated patients with various solid cancers. Initial findings show promising anti-tumor activity, durable objective responses, and a manageable safety profile. TCER® IMA401 demonstrated an “antibody-like” half-life of over two weeks, which supports dosing every two weeks and potentially once every four weeks in the future. The results mark an important milestone in demonstrating the clinical potential of Immatics’ new TCER® approach aimed at targeting a novel tumor-specific peptide derived from MAGEA4/8. These encouraging outcomes support further development of the candidate, with plans to focus on indications with high target expression in cancers such as lung and head and neck.
Read Announcement
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