- Molecular Templates Inc MTEM has decided to discontinue the development of MT-3724, its only first-generation engineered toxin bodies (ETB), and focus its resources on the development of next-generation ETBs.
- In November last year, FDA instituted a partial clinical hold on Phase 2 MT-3724 monotherapy study following a treatment-related fatality in one subject who experienced Grade 5 capillary leak syndrome.
- The FDA placed MT-3724 on a full clinical hold in late March and requested additional information and the development of a new MT-3724-specific quantitative assay, which would require significant time and investment.
- Following discussion with its co-development partner Takeda Pharmaceutical Co Ltd TAK, MTEM will assume full rights to TAK-169, including taking control of clinical development from Takeda.
- TAK-169 is an ETB consisting of a single-chain variable fragment (scFv) with an affinity for CD38.
- MTEM will focus on the development of next-generation ETBs MT-5111, TAK-169, and MT-6402 and advancing next-gen preclinical ETB candidates.
- TAK-169 is in an ongoing Phase 1 study with dose escalation planned through six dose cohorts. There have been no life-threatening toxicities and no signs of capillary leak syndrome. The maximum tolerated dose has not been reached, patient screening continues, and dose escalation is ongoing.
- Price Action: MTEM shares drop 25.3% at $9.29 in the market trading session on the last check Monday.
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