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# Molecular Templates IND for MT-5111
- URL: https://www.fdaweb.com/molecular-templates-ind-for-mt-5111/
- Published: 2019-04-22T12:00:00.000Z
- Updated: 2026-09-15T01:21:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143927

FDA has accepted a Molecular Templates IND application for MT-5111, an engineered toxin body (ETB) targeting HER2-positive solid tumors. The company expects to start dosing in a Phase 1 study in relapsed/refractory patients with HER2-positive solid tumors in the third quarter.

Molecular Templates describes MT-5111 as an ETB comprising a “single chain variable fragment with affinity for HER2, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA). MT-5111 specifically binds and kills HER2 expressing cells in a manner consistent with SLTA mediated cellular cytotoxicity.” MT-5111 has been designed to overcome the primary mechanisms of tumor resistance to current HER2 targeted therapies, the company says.