RE:RE:RE:RE:ONCY pelareorep + CD3 bispecific antibody true-killer comboDecember 09, 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and separately targets CD3 on T cells. This BLA is supported by data from the Phase 1/2, first-in-human MonumenTAL-1 study of talquetamab (Phase 1: NCT03399799; Phase 2: NCT04634552) in patients with relapsed or refractory multiple myeloma who have received more than three prior lines of therapy. The first presentation of Phase 2 results from the MonumenTAL-1 study will be highlighted at the American Society of Hematology (ASH) Annual Meeting on December 10, 2022 in an oral scientific session (Abstract #157) and featured as part of the ASH Press Briefing.
About Talquetamab
Talquetamab is a first-in-class, off-the-shelf (ready to use), investigational bispecific T-cell engager antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, a primary component of the T-cell receptor. CD3 is involved in activating T cells, and GPRC5D is highly expressed on multiple myeloma cells.
https://pipelinereview.com/index.php/2022120982242/Antibodies/Janssen-Submits-Biologics-License-Application-to-U.S.-FDA-for-Talquetamab-for-the-Treatment-of-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma.html