I-Mab : China Approves Phase 1b Trial Of Felzartamab In Systemic Lupus Erythematosus

(RTTNews) - I-Mab (IMAB) said that the Center for Drug Evaluation or CDE of the China National Medical Products Administration or NMPA has approved the Investigational New Drug or IND application to initiate a phase 1b trial of felzartamab, a CD38 antibody, in patients with systemic lupus erythematosus or SLE.

The phase 1b trial of felzartamab, also known as TJ202/MOR202, is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with SLE in China.

Felzartamab is a fully human and differentiated monoclonal antibody that targets dysregulated CD38-positive B cells responsible for the pathogenic inflammatory processes underlying SLE inducing immune-mediated tissue damage.

felzartamab is supposed to have a distinct advantage over conventional B-cell targeting therapies.

Preclinical studies suggest that felzartamab has disease-modifying potential in the treatment of SLE.

I-Mab is also currently conducting two parallel registrational trials with felzartamab to aim for registration for the treatment of multiple myeloma in Greater China.