JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation for Carteyva? (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) . Carteyva? is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics.

The Breakthrough Therapy Designation was supported by the results from the clinical study aimed to assess the efficacy and safety of Carteyva? in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical result obtained in Chinese patients.

Large B-cell lymphoma is a highly aggressive non-Hodgkin's lymphoma and is the most common subtype of lymphoma in adults. LBCL is a potentially curable disease, but 30-40% of patients still experience refractory or relapse1. Patients who fail first-line treatment have a poor outcome, and although conventional treatment options such as high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HDCT/ASCT) are the standard of care, approximately more than half of the patients are not suitable for ASCT due to a variety of reasons such as advanced age, comorbidities, and so on, and there is no standard of care with a very poor outcome2. There are still urgent unmet medical needs to develop additional active therapeutic approaches for the treatment of r/r LBCL.

References

1.     Sehn LH, Salles G. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. doi:10.1056/NEJMra202761.

2.     Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022;23(8):1066-1077. doi:10.1016/S1470-2045(22)00339-4.

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, Carteyva? has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, 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), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), 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 JWCAR029-216 Study (NCT06093841)

This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva? in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical study to evaluate such novel therapy in Chinese LBCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients.

The study is currently ongoing. Preliminary clinical data found Carteyva? providing outstanding efficacy and good safety profile for r/r LBCL patients, with a best overall response rate of 84%.

About JW Therapeutics

JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated 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 beyond, and to 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/.