US-based Biogen Inc. (NASDAQ: BIIB) announced the initiation of the TRANSCEND study, a global Phase III trial evaluating the efficacy and safety of its investigational drug felzartamab compared to placebo in adult kidney transplant recipients with late antibody-mediated rejection (AMR). This marks a significant step forward in addressing a critical condition affecting kidney transplant patients.
Felzartamab Profile
Felzartamab is a CD38-targeted monoclonal antibody (mAb) with potential first-in-class therapeutic applications across immune-mediated diseases. Originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company), the drug was licensed to I-Mab (Nasdaq: IMAB) for Greater China in November 2017. Rights outside Greater China were acquired by Human Immunology Biosciences (HI-Bio) in June 2022 and subsequently transferred to Biogen following its acquisition of HI-Bio in July 2024.
Clinical Trial Design
The TRANSCEND study will assess felzartamab’s impact on improving graft survival and reducing the progression of late AMR in kidney transplant recipients. This condition remains a significant challenge in transplant medicine, with limited therapeutic options available.-Fineline Info & Tech
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