Juno Therapeutics (JUNO) said late Thursday that its midstage leukemia trial had been put on clinical hold after two patients died. This was a Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia known as the “ROCKET” trial. The clinical hold was initiated after two patient deaths last week, which followed the recent addition of fludarabine to the pre-conditioning regimen. The FDA asked the company to submit a complete response to the clinical hold, including a revised patient informed consent form and trial protocol.
Juno Therapeutics, Inc. is a biopharmaceutical company developing cell-based cancer immunotherapies based on its chimeric antigen receptor (CAR) and T cell receptor (TCR) technologies to genetically engineer T cells to recognize and kill cancer cells. Its product candidates, JCAR015, JCAR017 and JCAR014, utilize CAR technology to target CD19, a protein expressed on the surface of various B cell leukemias and lymphomas. Its other product candidates include JCAR018: CD22, JCAR023: L1CAM (CD171), JCAR020: MUC-16/IL-12, ROR-1 and JTCR016: WT-1. JCAR015 is in Phase I open label clinical trial stage for patients with relapsed or refractory acute lymphoblastic leukemia (r/r ALL). JCAR017 is in Phase I/II trial for patients with pediatric r/r ALL. JCAR014 is in Phase I/II trial for treatment of various B cell malignancies in patients. JTRC016 is in Phase I/II clinical trial for the treatment of adult myeloid leukemia, myelodysplasic syndrome and chronic myeloid leukemia.
JUNO now stands at $30 per share in after hours. The long-term trend is obviously down. The all-time low is $22. The entire biotech sector is on edge of a potential major fall to boot.
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