Molecular Templates, Inc. Announces Fda Acceptance of Ind Application for Mt-6402, A Pd-L1-Targeted Engineered Toxin Body Enabled with Proprietary Antigen Seeding Technology
January 19, 2021 at 06:30 pm IST
Share
Molecular Templates, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for MT-6402, a next-generation ETB targeting PD-L1 that is enabled with MTEM’s antigen seeding technology (AST). ETBs enabled with AST have dual mechanisms of action that include the enzymatic destruction of ribosomes and the delivery of viral class I antigens into the targeted tumor to be processed and presented on its cell surface to induce an antigen specific immune response. MTEM expects to start dosing enrolled subjects in a first-in-human Phase 1 study in relapsed/refractory patients with PD-L1-positive solid tumors in 2Q21. The Phase 1 study is planned as a multi-center, open-label, dose escalation and dose expansion trial in the United States and outside of the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment in the clinical trial. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to study MT-6402 as a monotherapy in tumor-specific and tumor-agnostic 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. Announces Fda Acceptance of Ind Application for Mt-6402, A Pd-L1-Targeted Engineered Toxin Body Enabled with Proprietary Antigen Seeding Technology
MOLECULAR TEMPLATES, INC. 
