I-Mab Announces Chinese NMPA Approval for Phase 1b Trial of Felzartamab in Systemic Lupus Erythematosus
SHANGHAI and GAITHERSBURG, MD., June 25, 2021 / PRNewswire / – I-Mab (the “Company”) (NASDAQ: IMAB), a clinical-stage biopharmaceutical company engaged in the discovery, development and commercialization of new biologics, today announced that the Center for Drug Evaluation (CDE) from the China National Medical Products Administration (NMPA) approved the application for an investigational new drug (IND) to initiate a phase 1b test of felzartamab, a CD38 antibody, in patients with systemic lupus erythematosus (SLE).
The sentence 1b The felzartamab clinical trial, also known as TJ202 / MOR202, is a multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in patients with SLE in China. Felzartamab is a fully human, differentiated monoclonal antibody that targets CD38-positive deregulated B cells responsible for the pathogenic inflammatory processes underlying SLE inducing immune-mediated tissue damage. As it selectively targets pathogenic B cells involved in SLE, felzartamab is believed 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 .
“SLE is a chronic, incurable autoimmune disease that can cause damage to multiple organs. Current treatment options are very limited,” said Dr. Joan shen, CEO of I-Mab. “Felzartamab has the potential to alter the underlying pathophysiology of this disease and may offer a unique treatment option in the long-term clinical management of SLE if approved.”
I-Mab is also currently conducting two parallel registration trials with felzartamab to target registration for the treatment of multiple myeloma in Greater China. Felzartamab was originally derived from MorphoSys’ HuCAL® antibody technology and MorphoSys is currently evaluating the safety and efficacy of felzartamab in patients with anti-PLA2R antibody positive membrane nephropathy.
Felzartamab (TJ202 / MOR202) is an investigational human monoclonal antibody derived from the HuCAL® antibody technology of MorphoSys. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. Depending on its suggested mode of action, the antibody recruits cells from the body’s immune system to kill the tumor through antibody-dependent cell cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The antibody does not involve complement-dependent cytotoxicity, or CDC, an additional immune mechanism involved in the destruction of tumor cells. Scientific research suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a license agreement between MorphoSys and I-Mab signed in november 2017, I-Mab holds the exclusive rights for the development and commercialization of TJ202 / MOR202 on the continent China, Taiwan, Hong Kong and Macau.
HuCAL® is a registered trademark of MorphoSys AG.
I-Mab (Nasdaq: IMAB) is an innovation-driven global biotechnology company focused on the discovery, development and soon to commercialize new and highly differentiated biologics in the therapeutic area of immuno-oncology. The Company’s mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab’s globally competitive pipeline of more than 15 clinical and preclinical drug candidates is driven by its in-house R&D capability and global licensing partnerships, based on the unique advantages of Fast-to- Proof-of-Concept and Fast-to-Market of the Company. pipeline development strategies. The company is now rapidly progressing from a clinical-stage biotechnology company to a fully integrated global biopharmaceutical company with advanced global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global presence in Shanghai (Headquarter), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mabom LinkedIn, Twitter and WeChat.
I-Mab forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from preclinical studies of felzartamab, the potential implications of the clinical data for patients and the advancement of I-Mab. and the planned clinical development, regulatory milestones and commercialization of felzartamab. Actual results may differ materially from those shown in forward-looking statements due to various important factors including, but not limited to, I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates. ; the clinical results of its drug candidates, which may not support further development or NDA / BLA approval; the content and timing of decisions made by relevant regulatory authorities regarding the regulatory approval of I-Mab drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain intellectual property protection for its technology and drugs; I-Mab’s dependence on third parties to conduct drug development, manufacturing and other services; I-Mab’s limited operating history and I-Mab’s ability to secure additional funding for its operations and complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company’s clinical development, business and other operations, as well as the risks discussed in more detail in the “Risk Factors” section of I -Mab on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the United States Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab assumes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, events future or otherwise, except to the extent required by law.
For more information please contact:
Jielun Zhu, Chief Financial Officer
Email: [email protected]
Office line: +86 21 6057 8000
Gigi feng, head of communication
Email: [email protected]
Office line: +86 21 6057 5709
The Piacente Group, Inc.
Email: [email protected]
Office line: +86 21 6039 8363
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