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Immatics Initiates Third Phase I Clinical Trial of its Unique ACTengine® Platform in Patients with Advanced Solid Cancers
The clinical study (IMA203-101) is now open for enrollment at The University of Texas MD Anderson Cancer Center in Houston, Texas. It will initially include approximately 15 patients with relapsed and/or refractory solid tumors, for which no standard of care therapy is available.
Immatics’ ACTengine® approach engineers the patient’s own T lymphocytes (a type of white blood cell) to express a novel, exogenous T-cell receptor (TCR) which is targeted to a site on the tumor identified by Immatics’ proprietary XPRESIDENT® target discovery platform. ACTengine® combines several innovative features:
Patients are eligible for ACTengine® cell therapy if the target of interest is present on the patient’s tumor as demonstrated by biomarker profiling.
The TCR used in this trial has been selected from the human T-cell repertoire of more than one hundred TCRs for highest specificity, using Immatics’ XPRESIDENT®-guided on- and off-target toxicity screening.
The novel TCR recognizes its target with optimal affinity to enable an adoptive cellular therapy (ACT) approach that uses a proprietary TCR chain pairing enhancement technology for IMA203 to maximize the efficacy and safety features of ACTengine®.
The TCR-transduced T cells are activated and multiplied outside of the body before being infused into the patient. For IMA203, this process requires only 5-6 days of manufacturing time, allowing patients to be treated earlier than with most other comparable therapies.
The primary objective of the study is to evaluate the safety and tolerability of the ACTengine® approach, and specifically IMA203, in target-positive solid cancer patients.
The secondary objectives include the evaluation of feasibility, the persistence of T cells in vivo, and the assessment of anti-tumor activity and biomarkers.
The IMA203 phase I trial will be conducted by the Department of Investigational Cancer Therapeutics and the Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson Cancer Center in Houston, Texas. The principal investigators are Dr. Apostolia Tsimberidou and Dr. Amir Jazaeri.
Stephen L. Eck, M.D., Ph.D., Chief Medical Officer of Immatics US, commented: “This new study will be the third in Immatics’ series of ACTengine® studies which modify a patient’s existing T cells to recognize highly specific tumor antigens. These studies were built from Immatics’ unique XPRESIDENT® target discovery technology, which identifies novel tumor-specific T-cell targets. IMA203 will focus on a patient population distinct from that of our other studies, expanding the tumor indications Immatics seeks to treat. Collectively, the ACTengine® series of studies address a broad spectrum of human cancers by providing a therapy for each patient that is based on each individual’s unique tumor biology.”
Additional information about this study is available at www.clinicaltrials.gov.
The ACTengine® concept is based on genetically engineering a patient’s own T cells to express an exogenous T-cell receptor (TCR) to recognize the cancer cell targets as identified by Immatics’ XPRESIDENT® platform. ACTengine®uses high-avidity and high-specificity exogenous T-cell receptors (TCRs) identified from natural, human T-cell repertoires, which are introduced by viral vectors into patients’ T cells essentially “reprograming” these to recognize and kill the tumor cells. The engineered T cells are then grown up and reinfused back into the patient for treatment. Patients are potentially eligible for ACTengine® cell therapy if the target of interest is present on the patient’s tumor as demonstrated by a biomarker diagnostics test. The ACTengine® T-cell products are manufactured at The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with The University of Texas Health Science Center in Houston (UTHealth).
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