CAR-T Digest- August 2020

CAR-T Digest- August 2020

P-PSMA-101 P1 trial in mCRPC paused because of patient death – being investigated

17 Aug 2020

P-PSMA-101 (PSMA targeting CAR-T cell therapy) – Poseida Therapeutics

  • Poseida Therapeutics Phase 1 clinical trial for P-PSMA-101 in metastatic castrate-resistant prostate cancer (mCRPC) has been placed on clinical hold because of death due to liver failure on day 19
  • The cause of the liver failure has not been determined; the patient developed symptoms consistent with macrophage activation syndrome (MAS)
  • MAS is a serious and potentially fatal overactivation of the immune system which has been associated with CAR-T therapies but can have other causes such as infection and autoimmune disease
  • Assessment and evaluation of the next steps are ongoing. Poseida is waiting for a formal response from the FDA and is preparing their rebuttal. The FDA then has 30 days to notify Poseinda if the study can continue

FDA puts a hold on Phase 1 P-PSMA-101 study in mCRPC after a patient death

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CI Scientists Remarks: 

About CAR-Ts in solid tumors

  • The patient in question had failed treatment with multiple anti-cancer agents and was treated with P-PSMA-101 in late Jul’20
  • This is not the first CAR-T trial death, CAR-T JCAR015, developed and discontinued by Juno Therapeutics (Celgene/BMS), caused deaths due to cerebral edema
  • CAR-Ts are now being explored alone and in combinations in solid tumors. Eg. Poseida’s P-PSMA-101, Takeda’s TAK-102, Tmunity Therapeutics’ CAR-T-TnMUC1, PerHum Therapeutics’ CCT303-406, etc

About Poseida:

  • Following this setback shares of Poseida fell by 34%
  • In Aug’15, Poseida in-licensed Janssen Biotech’s Centyrin library; the technology Poseida use in their P-BCMA-101 and P-PSMA-101 assets
  • Other therapies in clinical development include P-BCMA-101, BCMA autologous CAR-T for multiple myeloma. Poseida is also developing allogeneic CAR-T product candidates (currently in preclinical stage) for indications like multiple myeloma, Prostate cancer, solid tumors, Hematologic malignancies etc

– Dr. Kowndinya, CI Scientists

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