Molecular Templates, Inc. has announced that the FDA, following a review of safety data concerning the program, has lifted the partial clinical hold on patient enrollment for the MT-0169 trial. This decision enables Molecular Templates to proceed with its intended assessment of MT-0169’s effectiveness. MT-0169 is one of the company’s ETBs designed to specifically target CD38, a validated focus in addressing Multiple Myeloma.
MT-0169 was developed to eliminate CD38+ tumor cells by internalizing CD38 and inducing cell destruction through a unique mechanism involving enzymatic ribosomal destruction and immunogenic cell death.
Eric Poma, the Chief Executive and Chief Scientific Officer of MTEM, expressed satisfaction with the FDA’s resolution. He highlighted that MT-0169 introduces an innovative approach to tackling myeloma, demonstrating favorable safety outcomes and early indications of potential clinical advantages.
Source: Molecular Templates Announces the FDA Removal of Partial Clinical Hold in the Phase 1 Clinical Trial for MT-0169 and Focuses on Extramedullary Myeloma.
https://www.mtem.com/news-media/press-releases/detail/124/molecular-templates-announces-the-fda-removal-of-partial
