Immatics Launches Phase 1/2 Clinical Trial to Evaluate IMA402, a Bispecific PRAME TCR, in Patients With Late-stage Solid Tumors
Friday, August 11, 2023
Immatics N.V. (NASDAQ: IMTX) has announced the commencement of a Phase 1/2 clinical trial for its novel Bispecific T cell Engaging Receptor (TCER®) IMA402, representing a significant step in the development of T cell-redirecting cancer immunotherapies. IMA402 is the second candidate from Immatics' TCER® pipeline to enter clinical development and is specifically designed to target a peptide derived from PRAME, a cancer-associated antigen commonly found in various solid tumors.
The Phase 1/2 trial (registered as NCT05958121) will focus on evaluating the effectiveness of TCER® IMA402 in patients who have HLA-A*02:01-positive status and are afflicted with PRAME-expressing recurrent and refractory solid tumors. The trial will begin with dose escalation and will follow a basket trial design, concentrating on indications such as cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer, and synovial sarcoma.
Dr. Cedrik Britten, Chief Medical Officer at Immatics, expressed enthusiasm about the inclusion of IMA402 in their pipeline and underscored its potential to enhance treatment outcomes by augmenting efficacy, minimizing adverse effects, and offering a patient-friendly dosing schedule. Dr. Britten emphasized the company's commitment to expediting IMA402's availability to a wider patient population and anticipates sharing preliminary clinical findings by 2024.
The primary objectives of the IMA402 Phase 1/2 trial encompass determining the maximum tolerated dose (MTD), suggesting dosing regimens for further investigation, and assessing the safety and tolerability of IMA402. The secondary objectives involve evaluating the therapy's anti-tumor activity and studying its pharmacokinetics. The trial will progress from the Phase 1a dose escalation stage to the Phase 1b dose expansion phase, with subsequent plans for a Phase 2 stage focusing on specific indications and potential combination therapies.
To accelerate IMA402's clinical development, Immatics has embraced an adaptive design for the dose escalation phase, while continually monitoring pharmacokinetics data to potentially allow adjustments in the treatment interval based on the extended half-life of TCER® format. The trial will initially involve approximately 15 European sites, expanding into the US during the dose expansion phase, and aims to enroll around 45 patients during Phase 1a.
The trial's initiation is grounded in comprehensive preclinical studies presented at the European Society for Medical Oncology (ESMO) Congress in 2022.
TCER® IMA402 represents Immatics' second program targeting PRAME, complementing the ongoing assessment of ACTengine® IMA203, a TCR-T cell therapy in the Phase 1b dose expansion phase. Both therapeutic approaches, TCER® and ACTengine®, offer diversified treatment options for cancer patients with distinct medical needs.
IMA402, a product developed by Immatics, underscores their innovative half-life extended TCER® molecules, designed to redirect and activate T cells against cancer cells expressing specific tumor targets. These molecules encompass a TCR domain for binding the cancer target peptide and a T cell recruiter domain to engage T cells against the tumor. Engineered for enhanced efficacy and minimized side effects, TCER® includes an Fc-part for heightened stability and extended duration. The "off-the-shelf" characteristic of TCER® biologics facilitates broader patient accessibility.
In conclusion, Immatics' Phase 1/2 clinical trial for TCER® IMA402 highlights their commitment to advancing groundbreaking cancer immunotherapies targeting PRAME-expressing solid tumors, with the potential to offer improved treatment alternatives and outcomes for a diverse array of patients.
