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Study results may pressure valuations of CAR-T developers

Jan. 26, 2016 1:36 PM ETJuno Therapeutics (JUNO) StockKITE, JUNO, CLLSBy: Douglas W. House, SA News Editor15 Comments
  • Juno Therapeutics (JUNO -0.8%) and Kite Pharma (KITE +3.9%) were under limited pressure earlier today in apparent response to the publication of an NIH study that showed encouraging results for an off-the-shelf engineered T-cell therapy in blood cancers. Investors appear to perceive, albeit modestly, that lower priced off-the-shelf CAR-Ts could pose a competitive threat to the customized and expensive CAR-Ts being developed by Juno and Kite.
  • The study, published in the Journal of Clinical Oncology, enrolled 20 patients with B-cell malignancies whose cancer had progressed after receiving an allogeneic hematopoietic stem cell transplant. Each received a single infusion of allogeneic T cells genetically engineered to express a chimeric antigen receptor (CAR) targeting the B-cell antigen CD19. No chemo or other therapies were administered.
  • Eight of the 20 patients obtained remission, including six complete remissions and two partials. The response rate was highest in the five patients with acute lymphoblastic leukemia, with four (80%) achieving minimal residual disease-negative complete responses. Responses were also observed in chronic lymphocytic leukemia (CLL) and lymphoma. One CLL patient maintained complete response status for more than 30 months.
  • No instances of graft-versus-host disease, a potentially serious autoimmune side effect, were observed. Adverse events included fever, tachycardia (rapid heart beat) and low blood pressure.
  • Juno and Kite's CAR-T candidates are customized for each individual.  A blood sample is taken, the T cells separated, genetically engineered to attack cancer cells and then reinfused back into the patient. Pricing has not been established yet, but the cost per procedure may be in the $400K - 500K range. Off-the-shelf versions would potentially have a distinct cost advantage due to scale economies.
  • Interested investors may want to research Paris, France-based Cellectis (CLLS +3.2%) which has generated some buzz with its off-the-shelf CAR-T approach.

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