Molecular Templates Inc. (NASDAQ:MTEM) has announced its Q3 2020 financial results and provided a clinical pipeline update. Molecular Templates reported revenue of $4.3 million in Q3 2020, which comprised collaborative research agreement revenues from Takeda and Vertex.
MT-3724 study put on partial hold
The company received a notice from the FDA on November 4, 2020, that it had partially halted the MT-3724 clinical trials. This was because of a treatment-related fatality in a study participant who experienced Grade 5 capillary leak syndrome in the second Phase MT-3724 monotherapy trial. The treated subject and four others in the second phase monotherapy study received treatment with material form, the MT-3724 products lot. The subjects expressed unexpectedly higher peak drug exposure (Cmax).
Following the halt, there will be no enrolment of new subjects in the study until the partial hold is lifted, but those subjects already enrolled will continue receiving the doses. However, there will be no changes to the studies or plans for the company’s other ETB product candidates, which include MT-5111, MT-6402, and TAK-169. All the product candidates employ the next generation ETB scaffold designed to eliminate or minimize propensity for innate immunity, which includes CLS.
Eric Poma, the Company’s CEO and Chief Scientific Officer, said that they are saddened by the death of the patient in the MT-3725 monotherapy study. As a result, the company has been collaborating with the FDA to fulfill information requests and thus resolve the partial hold and commence enrolment of the affected clinical studies. Poma said that for now, the company’s other ETB programs built on the next generation, proprietary de-immunized toxin scaffold with an easy manufacturing process are ongoing as scheduled. The company expects to offer study updates on the programs in late 2020 and early 2021.
Evaluating TAK-169 in relapsed/refractory multiple myeloma
The company and Takeda are evaluating TAK-169 in the ongoing Phase 1 study in the treatment of refractory/relapsed multiple myeloma. The study commenced dosing in February but paused temporarily in new study sites activation and enrollment of subjects because of the pandemic but commenced recently.