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DRUG:

IMA203

i
Other names: IMA 203, IMA203, autologous TCR-engineered T cells, ACTengine IMA203, IMA 2013, IMA203 T-cell product, IMA2013, IMA-2013, IMA-203
Associations
Trials
Company:
Immatics
Drug class:
PRAME inhibitor
Associations
Trials
3ms
Enrollment change
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Opdivo (nivolumab) • IMA203 • IMA203CD8
1year
Clinical • Metastases
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PRAME (Preferentially Expressed Antigen In Melanoma)
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IMA203
1year
Clinical • Metastases
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PRAME (Preferentially Expressed Antigen In Melanoma)
|
IMA203
1year
Metastases
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PD-1 (Programmed cell death 1) • PRAME (Preferentially Expressed Antigen In Melanoma)
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IMA203
2years
The PRAME opportunity - high peptide copy numbers, homogenous expression and high prevalence to address a broad patient population across different solid cancers with TCR-based therapeutics (SITC 2022)
Here, we describe the in-depth characterization of an HLA-A*02:01-presented peptide derived from the cancer germline antigen preferentially expressed antigen in melanoma (PRAME) that opens an avenue of new opportunities for patients with solid cancers which we aim to leverage by two distinct TCR-based therapeutic modalities, TCR-engineered T cells (ACTengine® IMA203) and TCR Bispecifics (TCER® IMA402). Conclusions Here, we demonstrate comprehensive target characterization and validation data supporting the nearly ideal target properties of PRAME that can be exploited for the benefit of patients: PRAME is highly cancer-associated, homogenously expressed, presented at high target density, highly prevalent across many solid cancers and clinically validated, underlining its potential to reach a large cancer patient population. Trial Registration NCT03686124 Ethics Approval The study was approved by the institutional review board/ethics committee as required for each participating site.
Clinical • IO biomarker
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HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)
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HLA-A*02 • PRAME expression
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IMA203 • IMA402
over2years
Clinical • Clinical data • P1 data
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PRAME (Preferentially Expressed Antigen In Melanoma)
|
IMA203
over2years
Clinical outcomes of solid cancer patients treated with autologous TCR-T cells targeting PRAME in the ongoing ACTengine® IMA203 phase 1 dose escalation trial (CIMT 2022)
IMA203 T cells are infused after lymphodepletion with fludarabine, and cyclophosphamide followed by low-dose IL-2. In summary, IMA203 shows a manageable safety profile and, to our knowledge, is the first TCR-T product candidate associated with frequent objective responses across multiple solid tumors at doses below 1 billion transduced T cells. Three expansion cohorts are currently being initiated to further study the safety and anti-tumor activity of IMA203 in solid tumors: IMA203 monotherapy at target dose, combination with a checkpoint inhibitor and a next-gen product candidate IMA203CD8 utilizing IMA203 co-transduced with a CD8 co-receptor.
Clinical • Clinical data • P1 data
|
CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)
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HLA-A*02
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cyclophosphamide • fludarabine IV • IMA203 • IMA203CD8
over2years
Enhanced preclinical anti-tumor activity of PRAME-specific next-generation TCR-T cells through CD8αβ co-expression (CIMT 2022)
Here, we show preclinical data from our next-generation product candidate IMA203CD8 utilizing the IMA203 TCR co-transduced with a CD8 co-receptor. The differential functional profiles of TCR-T cells co-expressing different types of CD8 constructs suggests that optimizing the type of co-receptor is relevant to maximize anti-tumor response and reveals CD8αβ to be the optimal co-receptor for the IMA203 PRAME TCR. Harnessing the anti-tumor potency of CD4 T cells may enhance depth and durability of anti-tumor responses and potentially improve the clinical outcome of TCR-T in patients with solid cancer.
Preclinical
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CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule) • PRAME (Preferentially Expressed Antigen In Melanoma)
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CD8 expression • HLA-A*02
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IMA203 • IMA203CD8
3years
Safety and anti-tumor activity of TCR-engineered autologous, PRAME-directed T cells across multiple advanced solid cancers at low doses – clinical update on the ACTengine® IMA203 trial (SITC 2021)
After lymphodepletion with fludarabine and cyclophosphamide, T cells are infused, followed by low-dose IL-2. The next step is to assess response rates at higher dose levels and durability of responses. Trial Registration NCT03686124
Clinical • Late-breaking abstract
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CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)
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fludarabine IV • IMA203
over3years
[VIRTUAL] First Anti-Tumor Activity Associated with Robust Biological Activity Observed in Early Phases of Dose Escalation Across Three TCR-T Trials (CIMT 2021)
Safety, biological activity and anti-tumoral efficacy are closely monitored throughout and following lymphodepletion with Fludarabine and Cyclophosphamide, T cell infusion and low dose IL-2 treatment. Taken together, treatment-emergent adverse events for ACTengine® product candidates were transient and manageable and in line with published data for autologous cell therapy in solid cancers. First anti-tumor activity in heavily pre-treated patients after infusion of low cell doses was unexpected, and together with robust biological activity warrants exploration of IMA201, IMA202 and IMA203 product candidates at target dose.
Tumor Mutational Burden • IO biomarker
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TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • MAGEA4 (Melanoma antigen family A, 4) • PRAME (Preferentially Expressed Antigen In Melanoma) • MAGEA1 (MAGE Family Member A1)
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fludarabine IV • IMA201 • IMA202 • IMA203