Pipeline

Information as of: August 2022

Abbreviations: LBCL = large B-cell lymphoma; FL = follicular lymphoma; MCL = mantle cell lymphoma; ALL = acute lymphoblastic leukemia; CLL = chronic lymphocytic leukemia; MM = multiple myeloma; NHL = non-Hodgkin lymphoma; HCC = hepatocellular carcinoma; NSCLC = non-small cell lung cancer; AFP = alpha-fetoprotein; GPC3 = glypican-3; r/r = relapsed or refractory; 3L = third-line; 2L = second-line; 1L= first-line, HAS= hepatoid adenocarcinoma of the stomach; SLE = systemic lupus erythematosus;

* Mainland China, Hong Kong, Macau and Taiwan refer to Mainland China, Hong Kong (China), Macau (China) and Taiwan (China), respectively.

  1. Relma-cel is based on the same chimeric antigen receptor (CAR) construct as the product lisocabtagene maraleucel (Breyanzi or lisocabtagene or liso-cel) of Juno Therapeutics, which was approved by the U.S. Food and Drug Administration (FDA) in February 2021.
  2. JWCAR129 is based on the same CAR construct as Juno Therapeutics’ product orvacabtagene autoleucel (orva-cel).
  3. Developing using Lyell technology.
  4. JWATM204 is in a Phase I investigator-initiated trial in China. Eureka’s products based on the CAR constructs underlying JWATM203 and JWATM204 are currently in Phase I/II trials in the US conducted by Eureka under an IND application. In November 2021, the FDA granted Fast Track Designation to Eureka’s counterpart to JWATM203 for the treatment of hepatoblastoma (HB) and HCC in pediatric patients, as well as “rare pediatric disease designation” for the treatment of HB. In February 2022, the FDA granted Orphan Drug Designation to Eureka’s counterparts to JWATM203 and JWATM 204.
  5. SLE is a chronic autoimmune disease characterized by the production of autoantibodies and abnormal B-lymphocyte function. To further extend relma-cel’s potential in broader disease area, we are planning a study to evaluate the safety, tolerability, and pharmacokinetic profile of relma-cel in Chinese patients with moderately or severely active SLE.

JW Therapeutics has strategically established a cell immunotherapy pipeline including seven candidate drugs or approved products, covering both hematological cancers and solid tumors, to provide breakthrough, quality, safe, and effective cell immunotherapy products to patients.

 

Potential Best-in-class Anti-CD19 CAR-T Product

 

JW Therapeutics’ lead product relmacabtagene autoleucel injection (trade name: Carteyva®) is the first CAR-T product independently developed in China, and was approved in China September 2021. With outstanding efficacy and safety profiles, Carteyva® has the potential to become a best-in-class product.

 

To fully explore the clinical potential of Carteyva®, JW Therapeutics is planning or conducting more clinical studies for more hematological oncology indications, including follicular lymphoma (FL), mantle cell lymphoma (MCL), second-line large B-cell lymphoma (2L LBCL), (adult, pediatric and young adult) acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).

 

JWCAR129

 

JWCAR129 is an autologous CAR-T cell immunotherapy drug targeting BCMA. BCMA is mainly expressed in multiple myeloma cell lines and cells from patients with multiple myeloma, and its expression increases with the progression of the disease, making it one of the ideal targets for the treatment of multiple myeloma (MM). JW Therapeutics plans to develop JWCAR129 for the treatment of multiple myeloma.

 

JWATM204

 

JWATM204 is an innovative TCR-T cell immunotherapy drug developed by JW Therapeutics based on Eureka's ARTEMIS® technology platform targeting glypican-3 (GPC-3), which combines the advantages of high affinity and high specificity of GPC-3 monoclonal antibody. GPC3 is a heparan sulfate (HS) glycoprotein on the cell membrane, which is expressed in about 80% of liver cancer patients and is also highly expressed in other solid tumors.

 

JW Therapeutics in-licensed the rights from Eureka to develop, manufacture and commercialize JWATM204 in China (including mainland China, Hong Kong, Macao and Taiwan) and the member countries of the Association of Southeast Asian Nations in 2020, and has completed technical transfer and renovation of facilities and equipment at Shanghai Waigaoqiao manufacturing site. JW Therapeutics plans to develop JWATM204 for the treatment of hepatocellular carcinoma and other solid tumors.