Drugs / IMA402
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | recurrent and/or refractory solid tumors | 2023-04-14 | “TCER® IMA402 is a next-generation, half-life extended TCR Bispecific for which Immatics submitted a clinical trial application (CTA 4 )” immatics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 4
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
IMA402 PRAME Bispecific at RP2D range resulted in a 30% cORR (6/20) across all indications, including 29% (4/14) in melanoma and 2/3 confirmed responses in ovarian carcinoma |
| 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 ↗
Today, Company discloses first clinical data from the TCR Bispecific molecule, TCER® IMA402 targeting PRAME, in the Phase 1 dose escalation trial, demonstrating a favorable tolerability profile and signs of dose-dependent and PRAME expression-dependent clinical activity |
| 2022-09-10 | Immatics Biotechnologies GmbH | Results Immatics Presents Comprehensive Preclinical Data Set for TCR Bispecific Candidate IMA402 Targeting PRAME at European Society for Medical Oncology (ESMO) Congress 2022 immatics.com ↗
In preclinical studies, IMA402 demonstrated enhanced anti-tumor activity in vivo and reduced T cell engager-associated toxicities as part of overall favorable in vitro safety profile |
| 2021-05-11 | Immatics Biotechnologies GmbH | Results Immatics Presents Preclinical Proof-of-Concept Data for TCR Bispecifics Program IMA402 Targeting PRAME immatics.com ↗
The lead candidate showed anti-tumor activity against PRAME-positive cancer cells leading to consistent reduction of the engrafted tumors, including complete responses in an in vivo mouse model. |
All press releases naming this drug 6 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMA402 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05958121 ↗ |
| Modality | Other / unclassified | “IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME” NCT05958121 ↗ |
| Route | Intravenous | “IV infusions” NCT05958121 ↗ |
| Target | PRAME | “Targeting PRAME” NCT05958121 ↗ |