Drugs / IMA401
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | solid adenocarcinoma with mucin production | — | “In November 2021, Immatics filed a Clinical Trial Application (CTA) 1 with Paul-Ehrlich-Institute (PEI), the German federal regulatory authority, for the development of IMA401.” immatics.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05359445 | May 2022 → Mar 2026 overdue | refractory malignant neoplasm | Immatics Biotechnologies GmbH | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05958121 | Aug 2023 → Sep 2027 expected | refractory malignant neoplasm | Immatics Biotechnologies GmbH | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-05-31 | Immatics Biotechnologies GmbH | Results Immatics Presents Data on IMA401 MAGEA4/8 Bispecific at 2026 ASCO Annual Meeting with Simultaneous Publication in Nature Medicine Supporting Development of IMA401/IMA402 Combination in Lung Cancer immatics.com ↗
In head and neck cancer, IMA401 treatment at recommended Phase 2 dose (RP2D) with or without pembrolizumab resulted in a 29% confirmed ORR (4/14), 64% DCR (9/14) and mDOR of 8.8 months; |
| 2025-11-12 | Immatics Biotechnologies GmbH | Results 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 immatics.com ↗
IMA401 MAGEA4/8 Bispecific at ≥1 mg resulted in a 25% cORR (2/8) in head and neck cancer, 29% cORR (2/7) in melanoma and promising clinical activity in sqNSCLC |
| 2024-11-18 | Immatics Biotechnologies GmbH | Results Immatics Announces Third Quarter 2024 Financial Results, Business Update and First Clinical Data on TCER® IMA402 Targeting PRAME immatics.com ↗
Clinical proof-of-concept data from the ongoing Phase 1 dose escalation trial with TCER® IMA401 targeting MAGEA4/8 demonstrate initial clinical anti-tumor activity in multiple tumor types and a manageable tolerability profile |
| 2024-09-16 | Immatics Biotechnologies GmbH | Results Immatics Presents Clinical Proof-of-Concept Data from Ongoing Phase 1 Dose Escalation Trial with TCR Bispecific Molecule TCER® IMA401 Targeting MAGEA4/8 at ESMO 2024 and Provides Development Update immatics.com ↗ |
| 2020-10-29 | Immatics Biotechnologies GmbH | Results Immatics Presents Preclinical Proof-of-Concept Data for TCR Bispecifics Program IMA401 Targeting MAGEA4/8 immatics.com ↗
Immatics demonstrated specific targeting and T cell recruitment to target-positive tumors by its proprietary TCR Bispecific molecule, leading to complete remissions of human-derived tumors in xenograft mouse models. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMA401 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05958121 ↗ |
| Modality | Protein / enzyme biologic | “bispecific T cell engaging receptor (TCER)” PMID 42219399 ↗ May 2026 |
| Route | Intravenous | “received intravenous IMA401” PMID 42219399 ↗ May 2026 |