Molecular Templates, Inc. Announces Fast Track Designation Granted by Fda for Mt-6402
November 18, 2021 at 08:00 am EST
Share
Molecular Templates, Inc. announced 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 expressing PD-L1. 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.
Molecular Templates, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted biologic therapeutics. The Companyâs proprietary drug platform technology, known as engineered toxin bodies (ETBs), leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer. Its product pipeline includes MT-6402, MT-8421 and MT-0169. MT-6402 is an ETB consisting of a single chain variable fragments (scFv), with affinity for PD-L1, fused to the enzymatically active de-immunized SLTA and a HLA-A*02 class I antigen derived from the human cytomegalovirus (HCMV) pp65 protein. MT-8421, its ETB targeting CTLA-4, along with MT-6402. MT-0169 is designed to destroy CD38+ tumour cells through internalization of CD38 and cell destruction via a novel mechanism of action (enzymatic ribosomal destruction and immunogenic cell death).
MOLECULAR TEMPLATES, INC. 
