JW Therapeutics Presents Latest Clinical Data on Carteyva® in Follicular Lymphoma and Mantle Cell Lymphoma at the 64th ASH Annual Meeting

SHANGHAI,Dec. 12,2022 -- JW Therapeutics (HKEX: 2126),an independent and innovative biotechnology company focusing on developing,manufacturing and commercializing cell immunotherapy products,presented the latest clinical data on Carteyva® (relmacabtagene autoleucel injection) in Chinese adults with relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory mantle cell lymphoma (r/r MCL) at the 64th American Society of Hematology (ASH) Annual Meeting.

Efficacy and Safety of Relmacabtagene Autoleucel in Adults with Relapsed/Refractory Follicular Lymphoma in China (abstract number: 4640)

In this pivotal phase II RELIANCE study,patients who had histologically confirmed grade 1,2,or 3a FL,with r/r disease were included. Eligible patients were randomized to received relma-cel at the dose level of 100×106 or 150×106 CAR+ T cells,following lymphodepletion chemotherapy. At data cut-off (Dec 17,2021),based on 28 patients with 11.7 months of median follow-up,relma-cel demonstrated remarkable clinical responses achieving high rates of complete response rate (CRR) and overall response rate (ORR) (6 months ORR,CRR were 100% and 83.33% respectively),and a manageable safety profile (only 1 patient experienced Gr ≥3 neurotoxicity (NT),no Gr ≥3 cytokine release syndrome (CRS)). Updated safety and efficacy data with a longer follow-up will be presented.

Preliminary Safety and Efficacy of Relmacabtagene Autoleucel (relma-cel) in Adults with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) in China (abstract number: 3326)

In this phase IIsingle-arm open-label study in China,participants with MCL underwent ≥2 lines of therapy including anti-CD20 antibody,anthracycline or bendamustine,and BTKis were included. After lymphodepleting chemotherapy,participants received relma-cel (100×106 CAR+ T cells). As of Nov 30,2021,the preliminary data of relma-cel based on 11 patients provided promising clinical efficacy outcome (best ORR 81.8%,best CRR 54.5%) in high risk patients with r/r MCL and a low incidence of grade ≥ 3 CRS (1 patient) and immune effector cell-associated neurotoxicity syndrome (ICANS,1 patient). This study is ongoing and further results will be presented.

About Relmacabtagene Autoleucel Injection (trade name: Carteyva®)

Relmacabtagene autoleucel injection (abbreviated as relma-cel,trade name: 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 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,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.

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