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Immatics Begins Phase I Trial of T-Cell Receptor Bispecific IMA401 in Advanced Solid Tumors

NEW YORK – Immatics said Tuesday that it is enrolling patients in a Phase I trial of its bispecific T-cell engager, IMA401, for patients with solid tumors.

Immatics, which has a presence in the US and in Germany, is developing IMA401 in collaboration with Bristol Myers Squibb, though Immatics is responsible for the Phase I trial now underway.

In this trial, the firm will establish a maximum tolerated dose of IMA401 and a recommended dose for a Phase II trial in patients with recurrent or refractory HLA-A*02:01 and MAGEA4/8-positive tumors. Immatics will enroll 50 patients at 15 centers in Germany in the study, which the company expects will yield preliminary data on IMA401's safety, tolerability, anti-tumor activity, and pharmacokinetics.

Immatics' T-cell receptor bispecifics, or T-cell engaging receptors (TCERs), are off-the-shelf products that activate T cells to attack cancer cells expressing specific targets. IMA401 is designed to simultaneously bind an HLA-A*02-presented peptide derived from melanoma-associated antigen 4 or 8 on the target cancer cell and recruit a T cell through a separate antibody domain. MAGEA4 and MAGEA8 are common in squamous non-small cell lung, head and neck squamous cell, bladder, uterine, esophageal, and ovarian carcinomas, as well as in melanoma and other tumor types.

In 2020, Immatics presented data at the European Antibody Congress from a preclinical proof-of-concept study of IMA401 showing complete remission of human-derived tumors in xenograft mouse models.

Last December, BMS paid Immatics $150 million upfront for exclusive rights to develop and commercialize IMA401 globally. In the deal, Immatics is also eligible for up to $770 million in development, regulatory, and commercial milestone payments, as well as royalty payments on net sales of the drug.

Among Immatics' other pipeline products, the firm is planning to begin a Phase I trial in 2023 for IMA402, another T-cell engaging receptor bispecific that targets the preferentially expressed antigen in melanoma (PRAME).

The company is also developing a line of adoptive cell therapies, autologous T-cell therapies engineered to target specific cancer targets. Its ACT products IMA201, IMA202, and IMA203 are in Phase I clinical trials. According to data the firm reported last year, nine out of 10 patients treated with any of those three products achieved disease control, and eight out of 10 had tumor shrinkage.