Pharma Focus Asia

Felzartamab Granted Breakthrough Therapy Designation for Primary Membranous Nephropathy (PMN) by the U.S. Food and Drug Administration (FDA)

Friday, November 03, 2023

I-Mab, a global biotechnology company listed on Nasdaq, and HI-Bio, a clinical-stage biotechnology company specializing in targeted therapies for patients with severe immune-mediated diseases (IMDs), have jointly announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to felzartamab, an investigational CD38 antibody. This designation is for the treatment of primary membranous nephropathy (PMN).

Breakthrough Therapy designation is awarded by the FDA to accelerate the development and evaluation of drugs intended to address serious or life-threatening conditions, provided that preliminary clinical data suggest a substantial improvement over existing therapies in terms of clinical outcomes.

The BTD for felzartamab is based on clinical data submitted to the FDA, including findings from the M-PLACE study, a Phase 1b/2a open-label study. The final analysis of the M-PLACE study is scheduled for presentation at the American Society of Nephrology (ASN) Kidney Week 2023 Annual Meeting.

I-Mab holds exclusive rights to develop and commercialize felzartamab for all indications in Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Felzartamab is being explored for applications in oncology and autoimmune diseases, with a Phase 3 registrational study underway for multiple myeloma in China.

I-Mab, expressed enthusiasm about the potential therapeutic benefits of felzartamab and noted that this designation represents a significant milestone for both companies, highlighting the commitment to evaluating felzartamab for multiple indications, including cancer and autoimmune diseases.

Primary Membranous Nephropathy (PMN) is an autoimmune kidney disease characterized by autoantibodies, leading to nephrotic syndrome in adults. Approximately 80% of PMN cases are linked to autoantibodies recognizing the phospholipase A2 receptor (PLA2R) antigen expressed on podocytes, which is essential for both diagnosis and prognosis. No approved therapies currently exist for PMN, and conventional treatments are often associated with limited effectiveness and potential toxicity.

Felzartamab is an investigational monoclonal antibody targeting CD38, a protein present on mature plasma cells. The antibody engages the body's immune system to eliminate malignant plasma cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Importantly, it does not involve complement-dependent cytotoxicity (CDC). This therapeutic approach has the potential to be applied not only in cancer but also in autoimmune diseases. I-Mab owns exclusive rights for the development and commercialization of felzartamab in Greater China, while HI-Bio holds exclusive global rights for felzartamab, excluding Greater China, following a licensing agreement with MorphoSys in 2022.



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