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Immatics Begins Phase I/II Trial of IMA402 in HLA-A*02:01-Positive Solid Tumors

NEW YORK – Immatics said on Thursday that it has started studying IMA402 in a Phase I/II clinical trial in advanced, HLA-A*02:01-positive, PRAME-expressing solid tumors.

The bispecific T-cell engaging receptor is designed to target a peptide derived from PRAME that is presented by HLA-A*02:01.

In the Phase I/II trial, Immatics will enroll 145 patients with solid tumors including cutaneous and uveal melanoma, ovarian cancer, lung cancer, and synovial sarcoma, among other cancer types. Immatics said it will not test patients with these cancer types — all of which are likely to have high and prevalent PRAME expression — but it will confirm PRAME expression in patients with other types of tumors when determining their eligibility for the trial.

Immatics, based in Tübingen, Germany, and Houston, is evaluating the bispecific molecule's safety, tolerability, and anti-tumor activity in this trial and expects to report initial data from it in 2024.

The trial has multiple parts: a Phase Ia dose-escalation portion followed by a Phase Ib dose-expansion portion, and then, in Phase II, patient cohorts are stratified according to tumor type and combination therapies. The trial has an adaptive design, allowing Immatics more flexibility over the treatment's clinical development timeline. The company will initially launch the trial at around 15 sites in Europe and expand into the US during the dose-expansion portion. The initial Phase Ia dose-expansion portion will include about 45 patients.

"With our half-life extended format, we believe IMA402 has the potential to be an attractive treatment option by enhancing efficacy, minimizing toxicities, and providing favorable dosing regimen for cancer patients," Immatics Chief Medical Officer Cedrik Britten said in a statement.