On September 8th, 2014 Molecular Templates reported that the US Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) Application to initiate clinical studies for MT-3724 as monotherapy for the treatment of refractory non-Hodgkin’s lymphoma (NHL) (Press release Molecular Templates, SEP 8, 2014, View Source [SID:1234500726]). MT-3724 is 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. MT-3724 is the first successful immunotoxin to CD20 and represents a novel mechanism of action in the treatment of NHL.

The FDA’s approval of the IND application for MT-3724 allows for the initiation of a Phase I program for MT-3724 which will assess the efficacy and safety of MT-3724 in patients with NHL who are resistant or refractory to all currently available therapies. The Phase I study will be conducted 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. Paul Hamlin, M.D., of the Lymphoma Service at Memorial Sloan-Kettering Cancer Center is the lead investigator for the study. Dr. Hamlin commented that “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.”

“The FDA’s decision clears the way for us to begin our Phase I study for MT-3724,” stated Eric Poma, Ph.D., CEO and CSO of Molecular Templates. “The MT-3724 Phase I study is an important milestone in the development of this compound and for the Company in general. We continue to advance additional compounds using our next-generation immunotoxin scaffold towards the clinic.”