Immatics Announces First Patient Treated with ACTengine® IMA203 TCR-T in Combination with Checkpoint Inhibitor Opdivo® (nivolumab) in Patients with Advanced Solid Tumors
Houston, Texas and Tuebingen, Germany, May XX, 2022 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that the first patient has been dosed in the IMA203 and nivolumab combination Phase 1b dose expansion cohort. This cohort will evaluate Immatics’ TCR-engineered cell therapy (TCR-T) approach ACTengine® IMA203 targeting an HLA-A*02-presented peptide derived from PRAME, in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor nivolumab, in patients with advanced solid tumors. The objectives of the study will be to evaluate the safety, biological activity, and initial anti-tumor activity of the IMA203 and nivolumab combination.
The IMA203 and nivolumab combination Phase 1b dose expansion cohort is expected to enroll up to 18 patients with different types of solid tumors across 10 clinical trial sites in Germany and the U.S. Bristol Myers Squibb will provide Immatics, the study sponsor of the combination trial, with nivolumab as part of a clinical supply agreement. Nivolumab has become the standard of care treatment for many solid cancer indications and we believe it fits well into the IMA203 treatment and observation schedule. According to the clinical trial protocol for ACTengine® IMA203, nivolumab will be administered at regular intervals following IMA203 treatment. The primary endpoint of this cohort is to assess the safety of the combination. Anti-tumor activity resulting from the drug combination is a secondary endpoint, which will be assessed through imaging and measured according to the standard Response Evaluation Criteria In Solid Tumors (RECIST).
The combination treatment of IMA203 and nivolumab is part of Immatics' strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. Based on this strategy, the company has expanded the IMA203 trial to a total of three Phase 1b dose expansion cohorts – each designed to assess observed objective response rates, demonstrate durability of response, and form the basis for enrollment in pivotal studies. In addition to the IMA203 and nivolumab combination (first patient treated, initial data read-out planned for YE 2022), Immatics will also investigate IMA203 as monotherapy (patient enrollment ongoing, next dat read-out planned in 2H 2022) and IMA203CD8, a next-generation cell therapy where IMA203-engineered T cells are co-transduced with a CD8aß co-receptor (initiation planned for 2Q 2022, initial data read-out planned for YE 2022).
About IMA203 and target PRAME
The ACTengine® T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine® Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).
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1 Opdivo® (nivolumab) is a trademark of Bristol-Myers Squibb Company