On November 18, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for MT-6402 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) expressing PD-L1 (Press release, Molecular Templates, NOV 18, 2021, View Source [SID1234595799]).
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"Fast Track Designation is an acknowledgement from the FDA of the potential of MT-6402 to address a significant unmet need in NSCLC," said Roger Waltzman, Molecular Templates’ Chief Medical Officer. "This designation will allow for continued contact with the FDA regarding the ongoing clinical program as well as future studies."
The Fast Track program is designed to accelerate the development and review of products such as MT-6402, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and may allow for further benefit from FDA accelerated programs such as priority review and/or rolling review.
MT-6402 is the first of MTEM’s third generation ETBs to enter the clinic. It was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the PD-L1 antibodies. MT-6402 is currently being evaluated in a multi-center, open-label, dose escalation and dose expansion Phase I trial in patients with solid tumors in the United States. Patient enrollment is currently ongoing. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and basket cohorts.