It took the FDA 500 days to impose a partial clinical hold on Molecular Template’s clinical trial for a CD38-directed cancer candidate but just 55 to lift it.
Molecular Templates revealed Thursday morning that the hold on the phase 1 MT-0169 trial for patients with multiple myeloma has been lifted. The FDA pushed pause on the study in early April, 500 days after the company itself disclosed the second of two cardiac adverse events in patients who had received the therapy. In the intervening time, Molecular Templates dialed down the dose and continued with the trial.
After the brief holdup, the trial has been cleared to go again. Molecular Templates said the agency reviewed safety data on the MT-0169 program and allowed enrollment to proceed. The events, which were reported to be myocarditis and nonischemic cardiomyopathy, were fully reversible and occurred in two patients who received a 50-mcg/kg dose. That has now been lowered to 5 mcg/kg. Patients who have been treated at lower doses have not shown signs of cardiac adverse events.
MT-0169 is being targeted at extramedullary myeloma, a type of the blood cancer that is less responsive to existing therapies and has a worse prognosis. Molecular Templates noted that about 20% of patients with relapsed/refractory multiple myeloma have this type of disease.
The lifting of the hold is good news for Molecular Templates, which earlier this year named MT-0169 one of its lead programs in a newly slimmed-down pipeline. The therapy was brought into the clinic by Takeda’s Millennium Pharmaceuticals in 2019 only to run into challenges and be returned to Molecular Templates in 2021. Then, the cardiac events upended the program.
Meanwhile, the company has had to take drastic action to keep above water in a challenging biotech market. Molecular Templates cut half of its 222-person team in March and halted development on a HER2 drug candidate.