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news.Biopharmaceutical firm Molecular Templates has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to start clinical studies for MT-3724 as monotherapy to treat refractory non-Hodgkin’s lymphoma (NHL).
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The company’s lead next-generation immunotoxin compound, MT-3724, is capable of forcing internalization against the CD20 B-cell surface marker and inducing direct cell death via ribosome inactivation in CD20-expressing cells.
It is the first successful immunotoxin to CD20 and represents a new mechanism of action in the treatment of NHL.
The approval allows for the start of a Phase I program which will evaluate the efficacy and safety of MT-3724 in patients with NHL who are resistant or refractory to all currently available therapies.
The Phase I trial will be carried out at Memorial Sloan-Kettering Cancer Center and New York University Langone Medical Center and will be expanded to include an additional premier oncology research center in Texas.
Memorial Sloan-Kettering Cancer Center Lymphoma Service Dr Paul Hamlin is the lead investigator for the trial.
Dr Hamlin said: "The MT-3724 immunotoxin represents an exciting new therapeutic, building on the already successful concept of targeted therapy in lymphoma with a novel immunotoxin possessing a different mechanism of action from other agents."