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

SHANGHAI, CHINA, December 12, 2022 An independent and creative biotechnology company called JW Therapeutics (HKEX: 2126) focuses on developing, manufacturing, and selling cell immunotherapy products. At the 64th American Society of Hematology (ASH) Annual Meeting, the company 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).

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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 receive 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.

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

People with MCL who took part in this phase II single-arm open-label study in China got at least two types of treatment, such as anti-CD20 antibodies, anthracycline or bendamustine, and BTKis. After lymphodepleting chemotherapy, participants received relma-cel (100×106 CAR+ T cells). As of Nov 30, 2021, the preliminary data based on 11 patients provided promising clinical efficacy outcomes (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.

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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. 

Nishant Mittal (PhD)

+ postsBio ⮌

Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.

Research Highlights

Dr. Mittal's research has focused on several key areas:

1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.

2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.

4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.

Publications and Presentations

Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.

In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.

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• March 6th, 2023