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Juno’s Investigational CAR T Cell Product Candidates JCAR018 and JTCR016 Demonstrate Encouraging Clinical Responses in Patients with B-Cell and Mesothelioma Cancers

SEATTLE--(BUSINESS WIRE)--

Juno Therapeutics, Inc. (JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced, in partnership with its collaborators, early clinical data from two oral presentations for two product candidates at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans, Louisiana.

JCAR018 is a chimeric antigen receptor (CAR) T cell product candidate targeting CD22, and had data from a Phase I trial in pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r ALL). JTCR016, a T cell receptor (TCR) cell product candidate targeting Wilms tumor-1 (WT-1), had data from a Phase I trial in patients with acute myelogenous leukemia (AML) at high risk of relapse following an allogeneic hematopoietic stem cell transplant and patients with either mesothelioma or non-small cell lung cancer.

“As we advance our CD19-directed portfolio, we are encouraged by the early signs of clinical activity from product candidates against different targets,” said Mark J. Gilbert, M.D., Juno’s Chief Medical Officer. “The data from JCAR018 suggest two paths to improve outcomes – use in patients with CD19 negative disease and a combination of CD19 and CD22 to decrease the risk of resistant cells and increase the percentage of patients that demonstrate a long-term durable remission in B cell malignancies. Additionally, JTCR016 continues to show an encouraging safety profile and signals of clinical activity, including evidence of tumor reduction as well as significant T cell expansion and persistence in a patient with mesothelioma.”

In an oral presentation on Monday, April 18, 2016, Terry J. Fry, M.D., Investigator, Pediatric Oncology Branch and Head of Hematologic Malignancies Section, National Cancer Institute, National Institutes of Health, presented “CD22 CAR Update and Novel Mechanisms of Leukemic Resistance.” Dr. Fry reported on CD22-directed CAR T cell therapy (JCAR018) in pediatric and young adult patients with r/r B-cell ALL. Key takeaways include:

  • Data from nine enrolled and treated patients were reported in this Phase I dose-escalation trial. (JCAR018; Clinical Trials Identifier: NCT02315612).
  • As previously reported at the American Society of Hematology meeting in December 2015, six patients were treated at the lowest dose, with one patient achieving a complete remission (CR) and complete molecular remission as measured by flow cytometry (CmR). This patient relapsed after three months.
  • Three patients have enrolled at dose level 2 (1 x 106 cells/kg), which is in the dose range of CD19-directed CAR T programs. All three patients achieved a CR and CmR. These patients remain in complete remission with follow-up ranging from 3 to 6 months.
  • The complete remissions have been seen in both patients naïve to CAR T therapies as well as those with CD19 negative relapse after prior CD19-directed CAR T therapy.
  • Limited cytokine release syndrome (CRS) was seen at dose level 2, with two patients at Grade 1 and one patient...

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