Drugs / IMA203
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | Other | — | — | 2020-08-18 | “German regulatory agency, Paul-Ehrlich-Institute (PEI), granted approval to commence another clinical ACTengine® trial in Germany investigating Immatics’ IMA203 product candidate” immatics.com ↗ “approval by Paul-Ehrlich-Institute to begin phase I clinical trial with product candidate IMA203 in Germany” immatics.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06946225 | Jul 2025 → Aug 2029 expected | cutaneous melanoma, synovial sarcoma | Immatics US, Inc. | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03686124 | May 2019 → Dec 2028 expected | refractory malignant neoplasm | Immatics US, Inc. | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06743126 | Jan 2025 → Jan 2028 expected | cutaneous melanoma | Immatics US, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Immatics Biotechnologies GmbH | Results Immatics Presents Clinical Activity and Response Dynamics of Anzu-cel PRAME Cell Therapy at 2026 ASCO Annual Meeting immatics.com ↗
One-time infusion of anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy induced rapid, deep and durable systemic anti-tumor activity in metastatic PD-1 relapsed cutaneous melanoma and metastatic uveal melanoma |
| 2025-10-20 | Immatics Biotechnologies GmbH | Results Immatics Highlights Compelling Anti-Tumor Activity of Anzu-cel PRAME Cell Therapy in Metastatic Uveal Melanoma at the ESMO 2025 Presidential Symposium immatics.com ↗
Anti-tumor activity observed across metastases throughout the body, including liver lesions, and in patients who received prior treatment with TCR-based therapies |
| 2025-05-31 | Immatics Biotechnologies GmbH | Results Immatics IMA203 PRAME Cell Therapy Data Presented at 2025 ASCO Annual Meeting Continues to Show Strong Anti-tumor Activity and Durability in Patients with Metastatic Melanoma immatics.com ↗
The longer follow-up of patients demonstrates a consistent and favorable tolerability profile as well as durable responses with a confirmed ORR of 56%. |
| 2024-11-08 | Immatics Biotechnologies GmbH | Results Immatics Announces Multiple Presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on TCR-T Therapy Candidates Targeting PRAME immatics.com ↗
Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced an expanded clinical dataset from the ongoing Phase 1b dose expansion clinical trial for ACTengine® IMA203 in addition to updated Phase 1 dose escalation clinical data on its next-generation ACTengine® IMA203CD8 TCR-T cell therapy. |
| 2024-10-10 | Immatics Biotechnologies GmbH | Results Immatics Announces Updated Phase 1b Clinical Data on ACTengine® IMA203 TCR-T Targeting PRAME in Melanoma Patients and Provides Update on Upcoming SUPRAME Phase 3 Trial immatics.com ↗
IMA203 demonstrates a confirmed objective response rate of 54% with median duration of response of 12.1 months in Phase 1b |
| 2024-05-14 | Immatics Biotechnologies GmbH | Results Immatics Announces First Quarter 2024 Financial Results and Business Update immatics.com ↗
55% confirmed objective response rate, including tumor shrinkage achieved in 87% of patients |
| 2023-11-08 | Immatics Biotechnologies GmbH | Results Immatics Reports Interim Clinical Data from ACTengine® IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial immatics.com ↗
50% confirmed objective response rate (cORR) in melanoma patients treated at recommended Phase 2 dose; durability with some ongoing responses at >15 months and median duration of response not reached at a median follow-up of 14.4 months |
| 2023-10-24 | Immatics Biotechnologies GmbH | Regulatory Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine® IMA203 TCR-T Monotherapy immatics.com ↗
The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients. |
| 2023-05-02 | Immatics Biotechnologies GmbH | Results Immatics Reports Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME immatics.com ↗
Objective response rate (ORR): 64% (7/11) initial ORR at week 6 and 67% (6/9) confirmed ORR at month 3 |
| 2022-11-17 | Immatics Biotechnologies GmbH | Results Immatics Announces Third Quarter 2022 Financial Results and Business Update immatics.com ↗
Interim clinical update on ACTengine® IMA203 TCR-T monotherapy targeting PRAME demonstrated high confirmed objective response rate (cORR) of 50% (6/12) at or above target dose across Phase 1a and Phase 1b; |
| 2022-10-10 | Immatics Biotechnologies GmbH | Results Immatics Reports Interim Clinical Data Update on ACTengine® IMA203 TCR-T Monotherapy Targeting PRAME immatics.com ↗
Confirmed objective response rate (cORR): 50% (6/12) at target dose or above with at least 1 billion infused TCR-T cells across Phase 1a and 1b |
| 2021-11-09 | Immatics Biotechnologies GmbH | Results Immatics Reports Clinical Responses across Multiple Solid Tumor Types in Ongoing ACTengine® IMA203 Phase 1a Trial Targeting PRAME immatics.com ↗
Data from patients treated at the first three of four dose levels of the ongoing IMA203 Phase 1a dose escalation study show a high preliminary objective response rate (partial responses according to RECIST 1.1) at doses below 1 billion total transduced cells. |
| 2021-03-17 | Immatics Biotechnologies GmbH | Results Immatics Presents Data Update on Dose Escalation from Ongoing ACTengine® Cell Therapy Programs immatics.com ↗
Overall, all product candidates demonstrated a manageable safety and tolerability profile. |
| 2020-08-18 | Immatics Biotechnologies GmbH | Regulatory Immatics Announces European Clinical Expansion of its Adoptive Cell Therapy Programs immatics.com ↗
In addition, Immatics has been granted regulatory approval by PEI to initiate another phase I clinical trial in Germany to evaluate safety, tolerability and initial signs of clinical efficacy of IMA203. |
All press releases naming this drug 17 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMA203 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03686124 ↗ |
| Modality | Cell therapy | “IMA203, an autologous preferentially expressed antigen in melanoma (PRAME)-directed TCR T cell therapy in HLA-A*02+ patients with PRAME+ recurrent and/or refractory solid...” PMID 40205198 ↗ Apr 2025 |
| Target | PRAME | “IMA203, an autologous preferentially expressed antigen in melanoma (PRAME)-directed TCR T cell therapy in HLA-A*02+ patients with PRAME+ recurrent and/or refractory solid...” PMID 40205198 ↗ Apr 2025 |