MT-0169

In the preclinical setting, MT-0169 effectively lysed primary MM cells from newly diagnosed and heavily pretreated MM patients, including those refractory to daratumumab, with minimal toxicity against nonmalignant hematopoietic cells. Finally, MT-0169 showed efficient in vivo anti-MM activity in various mouse xenograft models, including one in which MM cells are grown in a humanized bone marrow-like niche. These findings support clinical investigation of MT-0169 in relapsed/refractory MM patients, including those refractory to CD38-targeting immunotherapies.

P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=52 --> 0 | Trial completion date: Jul 2030 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2028 --> Oct 2024

P1, N=52, Not yet recruiting, M.D. Anderson Cancer Center

P1, N=14, Terminated, Molecular Templates, Inc. | N=54 --> 14 | Trial completion date: Dec 2024 --> Dec 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2024 --> Dec 2023; Sparse/no patient enrollment

P1, N=54, Active, not recruiting, Molecular Templates, Inc. | Recruiting --> Active, not recruiting

P1, N=54, Recruiting, Molecular Templates, Inc. | Active, not recruiting --> Recruiting

P1, N=54, Active, not recruiting, Molecular Templates, Inc. | N=144 --> 54 | Trial primary completion date: Jan 2024 --> Aug 2024

Three ETBs (MT-0169, MT-5111, and MT-6402) are currently in clinical studies across different targets (CD38, HER2, PD-L1) and across hematologic malignancies, solid tumor, and immuno-oncology indications. ETBs can also deliver additional payloads to drive unique biology like the alteration of tumor immunophenotype. Here we describe three active clinical stage programs with encouraging safety and efficacy data that represent a transformation of the immunotoxin landscape into a more viable therapeutic approach to target validated as well as typically intractable clinical cancer targets.

Clinical activity was seen in heavily pre-treated hematological malignancies with a first-generation ETB (MT-3724) targeting CD20...Prior treatment with an anti-CD38 therapy (including daratumumab) is permitted...The trial is currently recruiting at three US sites. (NCT04017130)