I-Mab:Felzartamab Granted Breakthrough Therapy Designation By FDA For Primary Membranous Nephropathy

(RTTNews) - I-Mab (IMAB) and HI-Bio said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for felzartamab, an investigational CD38 antibody, for the treatment of primary membranous nephropathy.

Primary membranous nephropathy is a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome (NS) in adults worldwide.

The designation for felzartamab was based on clinical data submitted to the FDA, including results from M-PLACE, a Phase 1b/2a proof-of-concept, open-label study led by I-Mab partner HI-Bio.

The FDA selectively grants Breakthrough Therapy Designation to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition, and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

I-Mab has the full rights to develop and commercialize felzartamab for all indications in Greater China which encompasses Mainland China, Hong Kong, Macau, and Taiwan. I-Mab is evaluating felzartamab in oncology and autoimmune diseases.

I-Mab is currently conducting a Phase 3 registrational study of felzartamab in combination with lenalidomide and dexamethasone as a second-line treatment for multiple myeloma (MM) in China with progression-free survival (PFS) as the primary endpoint, with a projected read-out in 2024, followed by a planned BLA submission.

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