Molecular Templates Stock Falls After It Stops MT-3724 Development In Hematological Malignancies

  • 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.
Posted In: Hematological MalignanciesBiotechNewsHealth CareSmall CapFDAGeneral