On March 28, 2019 Molecular Templates, Inc., (Nasdaq: MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported the initiation of a single-agent Phase II study of MT-3724, a CD20-targeted ETB, in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients (Press release, Molecular Templates, MAR 28, 2019, View Source [SID1234534732]). This multicenter study will enroll up to 100 patients, in a staged manner, who have received at least two standard of care treatment regimens for DLBCL. As a monotherapy study in heavily pretreated patients, this study has the potential to be pivotal.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We have been highly encouraged by the responses observed in the Phase I/Ib study of MT-3724 in heavily pretreated DLBCL patients," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "This Phase II study largely replicates the Phase Ib expansion cohort, but with more clinical sites for enrollment, an independent data safety monitoring board, and independent central review for efficacy. Given the high level of unmet need in advanced DLBCL, we hope that this study will confirm that MT-3724 provides a meaningful benefit for this difficult to treat patient population."
The Phase II study will initially enroll patients at sites in the United States, Canada and Europe. MT-3724 will be given as 50 mcg/kg intravenous (IV) infusions, with a maximal per dose limit of 6,000 mcg. The primary outcome measure is tumor response, while secondary objectives include safety and other efficacy measures. The Phase II dose of 50 mcg/kg was selected based on safety data, tumor responses observed at dose levels as low as 5 and 20 mcg/kg, and pharmacodynamic effects of CD20+ B-cell clearance observed at various doses in the Phase I/Ib study. The Phase II study will exclude patients with high levels of serum rituximab, given CD20 binding competition of rituximab with MT-3724.