Immatics Initiates the First Phase I Clinical Trial of its Unique ACTengine® Approach in Patients with Advanced Solid Cancers
Houston, Texas and Tuebingen, Germany, September 28, 2017 – Immatics, a leading company in the field of cancer immunotherapy, today announced that it has initiated enrollment of patients into a phase I trial of IMA201, its first T-cell Receptor (TCR)-transduced adoptive cell therapy program. IMA201 is an investigational immunotherapy which uses Immatics’ proprietary ACTengine® approach, and is based on genetically engineering a patient’s own T-cells to express an exogenous TCR. The goal is to redirect and activate the cells to treat solid tumors. The single-center clinical study is now open for enrollment at The University of Texas MD Anderson Cancer Center in Houston, Texas.
The study (IMA201-101) will include up to 16 patients with relapsed and/or refractory squamous non-small cell lung cancer or head and neck squamous cell carcinoma, for which no standard of care therapy is available.
Immatics’ ACTengine® approach engineers the patients’ 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 as identified by Immatics’ proprietary XPRESIDENT® target discovery platform. ACTengine® combines several innovative features:
• TCRs specifically recognizing the XPRESIDENT® identified target are selected via Immatics’ high-throughput TCR discovery platform from the natural, human T-cell repertoire. The TCR used in this trial has been selected for highest specificity from more than hundred TCRs using Immatics’ XPRESIDENT®-guided on- and off-target toxicity screening.
• The novel TCR recognizes its target with optimum affinity for an adoptive cellular therapy (ACT) approach.
• The TCR-transduced T-cells are multiplied and activated outside the body before being infused into the patient.
• 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 primary objective of the study is to evaluate the safety and tolerability of the ACTengine® approach, and specifically IMA201, 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. Professor George Blumenschein, Jr., M.D., in the Department of Thoracic Oncology at MD Anderson (Department Chair: Professor John Heymach, M.D., Ph.D.) is the Principal Investigator for the IMA201 phase I trial.
Carsten Reinhardt, M.D., Ph.D., Chief Medical Officer and Managing Director of Immatics, commented: “Having received regulatory approval to start clinical development of our first ACTengine®-based cell therapy program is a significant step for Immatics. It underscores the unique expertise Immatics has been building over the past years with the XPRESIDENT® target discovery and the Immatics TCR discovery pipeline being industry-leading cancer immunotherapy platforms. We are very excited now to be combining these capabilities with the world-class expertise of investigators from MD Anderson in order to develop promising new treatment options for cancer patients with significant unmet medical need.”
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 eligible for ACTengine® cell therapy if the target of interest is present on the patient’s tumor as demonstrated by a biomarker diagnostics tests.
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