JW Therapeutics Announces IND Approval for the Clinical Trial of Carteyva® in Pediatric and Young Adult Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

SHANGHAI,April 20,2022 -- JW Therapeutics (HKEx: 2126),an independent,innovative biotechnology company focused on developing,manufacturing and commercializing cell immunotherapy products,announced the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for the study of the anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) in treating pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

B-cell acute lymphoblastic leukemia (B-ALL) is the most common malignancy in paediatric[1]. Resistance to chemotherapeutic agents resulting in disease relapse and progression,and survival following relapse is poor in patients with B-ALL. Salvage chemotherapy could be an option,but it is not sufficient to cure relapsed or refractory aggressive disease. Long term survival was limited due to poor response,low remission rate,and high relapse rate after salvage chemotherapy. At present,there is no standard effective treatment for r/r B-ALL. Allogeneic hematopoietic stem cell transplantation(allo-HSCT) emerged as a promising strategy,nevertheless,the long-term survival rate still cannot achieve satisfaction[2]. Disease relapse after therapies remain a significant challenge,and novel treatment options are still urgently needed to prolong the long-term survival for patients with r/r B-ALL.

This study (JWCAR029-006) a phase I,open-label,single-arm,dose escalation study in China,which aims to evaluate the safety,efficacy,and pharmacokinetics profile of Carteyva® in pediatric and young adult patients with r/r B-ALL,and also to determine the recommended phase II dose (RP2D).

References

1. Araoz,H. V.,D'Aloi,K.,Foncuberta,M. E.,Sanchez La Rosa,C. G.,Alonso,C. N.,Chertkoff,L.,& Felice,M. (2015). Pharmacogenetic studies in children with acute lymphoblastic leukemia in Argentina. Leuk Lymphoma,56(5),1370-1378. doi:10.3109/10428194.2014.951844

2. Spyridonidis,A.,Labopin,M.,Schmid,C.,Volin,Yakoub-Agha,I.,Stadler,M. Rocha,V. (2012). Outcomes and prognostic factors of adults with acute lymphoblastic leukemia who relapse after allogeneic hematopoietic cell transplantation. An analysis on behalf of the Acute Leukemia Working Party of EBMT. Leukemia,26(6),1211-1217. doi:10.1038/leu.2011.351

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 was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy,making it the first CAR-T product approved as 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,granted 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. Founded in 2016,JW Therapeutics is committed to becoming an innovation leader in cell immunotherapy. The company has built a top world-class platform for technology and product development in cell immunotherapy,as well as a promising product pipeline covering both hematologic malignancies and solid tumors,to bring the hope of a cure for Chinese and global patients,and to lead the healthy and standardized development of China's cell immunotherapy industry. For more information,please visit www.jwtherapeutics.com.

Forward-Looking Statements

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