Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMA203 · 2 trials · 3 indications
progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1
Number of DLTs will be used to determine the maximum tolerated dose (MTD) and/or recommended dose for extension (RDE) after treatment with IMA203 product in combination with mRNA-4203
Used to evaluate safety and tolerability of treatment with IMA203 in combination with mRNA-4203
| Arm | Type | Description |
|---|---|---|
| Experimental arm | EXPERIMENTAL | Non-myeloablative chemotherapy for lymphodepletion (LD) over 4 days using fludarabine (FLU) and cyclophosphamide (CY), one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy |
| Control arm- investigator's choice | ACTIVE_COMPARATOR | Investigator's choice of treatment approved by the respective Competent Authority (nivolumab plus relatlimab \[Opdualag®\], lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy \[e.g., dacarbazine, temozolomide, paclitaxel, alb-bound paclitaxel, or paclitaxel plus carboplatin\]) as determined by the site investigator in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC), optional bridging therapy. |
| IMA203 with mRNA-4203 in participants with metastatic cutaneous melanoma or synovial sarcoma | EXPERIMENTAL | This is a non-comparative, open-label trial with different cohorts investigating IMA203 in combination with mRNA-4203. |
| Name | Type | Description |
|---|---|---|
| IMA203 | BIOLOGICAL | one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy |
| nivolumab plus relatlimab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| lifileucel | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| nivolumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| pembrolizumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| ipilimumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| Dacarbazine | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| temozolomide | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| paclitaxel | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| paclitaxel plus carboplatin | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| Albumin-Bound Paclitaxel | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| mRNA-4203 | BIOLOGICAL | mRNA-4203 will be administered starting on Day 15 after IMA203 infusion at the earliest. mRNA-4203 will be given for 12 cycles (28 day cycle length); during Cycle 1 it will be given on Day 1 and Day 15 and in Cycles 2-12 it will be given on Day 1. |
Inclusion Criteria: * Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) with unresectable or metastatic disease * HLA-A\*02:01 positive * Adequate selected organ function per protocol * Eastern Cooperative Oncology Gro...
IMA203 is an investigational monoclonal antibody being developed for the treatment of cutaneous melanoma, including unresectable or metastatic forms. It is also being studied in combination with mRNA-4203 for cutaneous melanoma and synovial sarcoma. IMA203 is not yet approved and is currently in clinical development.
IMA203 is a monoclonal antibody designed to target PRAME, a tumor-associated antigen. PRAME is expressed in various cancers, including melanoma and synovial sarcoma. By targeting PRAME, IMA203 aims to direct the immune system against cancer cells that express this antigen.
IMA203 is being developed by Immatics N.V., a biopharmaceutical company. Immatics is publicly traded on the Nasdaq under the ticker symbol IMTX. The company is conducting clinical trials to evaluate the safety and efficacy of IMA203 in patients with certain types of cancer.
IMA203 is currently in Phase 1 clinical trials. One trial is a Phase 1 study combining IMA203 with mRNA-4203, while another trial, SUPRAME, is listed as Phase 3 but is still recruiting. IMA203 has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
IMA203 is being studied in two clinical trials. NCT06743126, the SUPRAME trial, is a Phase 3 study in previously treated unresectable or metastatic cutaneous melanoma with 360 participants. NCT06946225 is a Phase 1 trial combining IMA203 with mRNA-4203 in cutaneous melanoma and synovial sarcoma with 15 participants.
Yes, IMA203 is also referred to as ACTengine IMA203. The clinical trials use the name ACTengine IMA203 to describe the therapy. This naming reflects the platform used to generate the engineered T cell receptor therapy, which is part of the ACTengine approach developed by Immatics.