CAR-T Digest- August 2020

CAR-T Digest- August 2020

CARsgen Therapeutics received IND clearance from the National Medical Products Administration (NMPA) in China for CT041 CLDN18.2-CAR-T cells

20 Aug 2020

CT041 (Claudin18.2-targeted CAR-T-cell therapy) – CARsgen Therapeutics

  • NMPA has cleared the IND application for CARsgen Therapeutics’ first-in-class drug candidate CT041, autologous chimeric antigen receptor (CAR) T cells for the treatment of claudin18.2-positive solid tumors
  • CT041 is the first claudin18.2-targeted CAR-T-cell therapy with IND clearance for clinical trials in China

CARsgen’s claudin18.2-targeted CAR-T gets IND approval in China

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CI Scientists Remarks: 

  • Founded in 2014, CARsgen is based in Shanghai, with operations in China and US
  • Human CLDN18.2, expressed abundantly in gastric and pancreatic adenocarcinomas, makes a ideal drug target for these tumor types
  • In 2017, CARsgen developed Claudin18.2-CAR-T cell in collaboration with Shanghai Cancer Institute
  • Based on results from Phase 1 investigator initiated study (N=12; ORR: 33.3%, disease control rate: 75%) of Claudin18.2- CAR-T for solid tumors in China, company applied for IND in US followed by China
  • Following an IND approval in May’20 a Phase 1 study for gastric and pancreatic cancer was registered in the US. Recruitment initiation expected in Q3’20
  • Other therapies in clinical development includes: GPC3 CAR-T (HCC, NSCLC), BCMA CAR-T (MM), CD19 CAR-T (B cell lymphoma) and AB011, claudin18.2 mAb (Gastric/Pancreatic/Esophageal/Colon Cancer)

– Dr. Kowndinya, CI Scientists

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