JW Therapeutics Announces IND Approval for the Clinical Trial of Relma-cel in Patients with Moderately or Severely Refractory Systemic Lupus Erythematosus

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SHANGHAI, April 10, 2023 /PRNewswire/ -- JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a clinical trial of relmacabtagene autoleucel injection (relma-cel) in patients with moderately or severely refractory systemic lupus erythematosus (SLE).

SLE is a complex autoimmune disease with diverse clinical manifestations involving many organs and systems. It is estimated that China has 1 million SLE patients currently. Although the long-term survival of SLE patients has improved in recent years, the inevitable relapse and irreversible organ damage are common causes of the death of SLE patients. Mortality rate in SLE patients is two to three times higher than that of the general population. Therefore, innovative therapy is urgently needed to maintain the remission of disease symptoms, control organ damage, and improve long-term patient outcomes.

Clinical studies published in the New England Journal of Medicine (NEJM) and Nature Medicine have demonstrated the remarkable efficacy of CD19-targeted CAR-T cells in the treatment of SLE patients. Relma-cel may provide a novel, safe and effective treatment option for patients with moderate or severe SLE.

This is an open, single-arm, multi-center phase I/II study in adults with moderately or severely refractory SLE. Phase I of the study is a dose escalation study to assess the safety and tolerability of relma-cel and to determine the recommended phase II dose (RP2D). Phase II of the study is an extension study treating with RP2D of relma-cel to determine the efficacy and safety in moderately or severely refractory SLE patients, and to evaluate the pharmacokinetic and pharmacodynamic characteristics.

James Li, Co-founder, Chairman and CEO of JW Therapeutics, said, "Autoimmune diseases are a critical part of JW Therapeutics' strategy. We are committed to maximizing the clinical value of relma-cel, and look forward to providing a new treatment option for patients with autoimmune diseases."

References

中华医学会风湿病学分会, 国家皮肤与免疫疾病临床医学研究中心, 中国系统性红斑狼疮研究协作组. 2020中国系统性红斑狼疮诊疗指南. 中华内科杂志, 2020, 59(3): 172-185.

Barber MRW, et al. Global epidemiology of systemic lupus erythematosus Nat Rev Rheumatol. 2021 Sep;17(9):515-532

Mackensen, A., Muller, F., Mougiakakos, D., Boltz, S., Wilhelm, A., Aigner, M., Volkl, S., Simon, D., Kleyer, A., Munoz, L., et al. (2022). Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med 28, 2124-2132. 10.1038/s41591-022-02017-5.

Mougiakakos, D., Kronke, G., Volkl, S., Kretschmann, S., Aigner, M., Kharboutli, S., Boltz, S., Manger, B., Mackensen, A., and Schett, G. (2021). CD19-Targeted CAR T Cells in Refractory Systemic Lupus Erythematosus. N Engl J Med 385, 567-569. 10.1056/NEJMc2107725.

About Relmacabtagene Autoleucel Injection

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva^®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBLC) after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

About JW Therapeutics

JW Therapeutics (HKEX: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and worldwide, and leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.

Forward-Looking Statements

The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEX) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.

SOURCE JW Therapeutics