Molecular Templates (NASDAQ:MTEM) IND application for MT-5111, an engineered toxin body targeting HER2, has been accepted by the FDA.
MT-5111’s single chain variable fragment and Shiga-like toxin-A subunit respectively target and kill HER2-expressing cancer cells. MT-5111 is designed to overcome tumor resistance associated with current HER2 targeted therapies, and since it binds to a distinct HER2 domain, it has the potential to be combined with HER2-targeting drugs such as Herceptin.
“We are excited to be advancing MT-5111, which utilizes our proprietary de-immunized toxin scaffold, into the clinic for the treatment of patients with HER2-positive cancers,” Eric Poma, Molecular Templates’ CEO and CSO, said in a statement.
“HER2 is a well validated target that is central to disease and when existing HER2-targeting therapies fail, the target persists, suggesting that a HER2-targeted therapy with a new mechanism of action has good potential to provide benefit to patients,” he added.
The planned Phase 1 study, expected to begin in the third quarter of 2019, will evaluate the safety and tolerability of MT-5111 in relapsed or refractory patients with HER2-positive solid tumors, as well as determine the recommended Phase 2 dose.