Molecular Templates, Inc.

Pipeline

A Pipeline of Differentiated Oncology Candidates

Engineered toxin bodies (ETBs) are differentiated biologic therapies with unique properties.  Single agent activity and tolerability have been observed with ETB therapy in heavily relapsed/refractory patients.

Program Partner Indication (Target) Preclinical Phase 1 Phase 2 Phase 3 Next Stage
MT-6402 Multiple - solid tumors (PD-L1)
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
MT-8421 Multiple – solid tumors (CTLA-4)
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
MT-0169 Multiple Myeloma (CD38)
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
Completed
In-progress
Planning

MT-6402

Next-Generation ETB Targeting PD-L1

MT-6402 is an ETB candidate designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the PD-L1 antibodies. The IND for MT-6402 was accepted in January 2021 and a Phase 1 study of MT-6402 in PD-1/PD-L1 antibody relapsed/refractory patients initiated in July 2021.

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MT-8421

Next-Generation ETB Targeting CTLA-4

MT-8421 is an ETB candidate designed to preferentially destroy high CTLA-4-expressing Tregs in the tumor microenvironment (“TME”) relative to peripheral Tregs, which are lower CTLA-4 expressing, through a direct cell-kill mechanism independent of the effector cell presence that antibodies rely upon while not effecting Tregs in the periphery, the major mechanism of antibody-mediated autoimmune toxicity. Preclinical data from MT-8421 showed that in a transgenic mouse model expressing human CTLA-4 and bearing syngeneic subcutaneous tumors, MT-8421 treatment depleted immune suppressive Tregs in the TME but not in the periphery. MT-8421 was well tolerated in a non-human GLP primate toxicology study and achieved serum levels well-above projected IC50 concentrations for Tregs in the TME. The IND for MT-8421 was accepted March 2023 and a Phase 1 study of MT-8421 is expected to initiate mid-year 2023.

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MT-0169

Next-Generation ETB Targeting CD38

MT-0169 is an ETB candidate that has been shown pre-clinically to bind and kill CD38 expressing cells in a way that is consistent with SLTA mediated cellular cytotoxicity. MT-0169 is currently in a first-in-human Phase 1 dose-escalation study of relapsed/refractory myeloma patients.

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