On July 30, 2015 Juno Therapeutics, Inc. (Nasdaq:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational new drug (IND) application for JCAR015 for treatment of adult patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL) (Press release, Juno, JUL 30, 2015, View Source [SID:1234506765]). Schedule your 30 min Free 1stOncology Demo! The IND enables Juno to initiate a multi-center, pivotal Phase 2 trial evaluating JCAR015 in patients with r/r ALL. The trial is scheduled to begin in the near term, with the potential to file for registration by late 2016 or early 2017. JCAR015, Juno’s most advanced product candidate, is an autologous chimeric antigen receptor (CAR) T cell immunotherapy targeting CD19, a protein expressed on the surface of most B cell leukemias and lymphomas.
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"Based on the encouraging results of JCAR015 in its Phase 1 adult ALL trial conducted by Memorial Sloan Kettering Cancer Center, we are excited to begin Juno’s first pivotal trial investigating this product candidate in a multi-center study," said Mark Frohlich, M.D., Juno EVP of development and portfolio strategy. "FDA clearance of the JCAR015 IND for this pivotal Phase 2 trial is a significant milestone for the company, highlighting the early returns on the investments we have made in process development and manufacturing as well as providing clarity on a potential path toward our first product approval."
The initial trial to be conducted under this IND is titled "Protocol 015001: A Phase 2, single-arm, Multicenter Trial to Determine the Efficacy and Safety of JCAR015 in Adult Subjects with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (The ROCKET Study)." The primary objective of this trial is to evaluate the efficacy of JCAR015 as measured by overall remission rate in subjects with morphologic evidence of disease (5% or more leukemic blasts in the bone marrow). The trial will also evaluate the safety and tolerability of the therapy. The study will open at 14 clinical sites in the U.S. and enroll approximately 90 subjects in order to achieve 50 subjects with morphologic disease following salvage chemotherapy.
About Juno’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s chimeric antigen receptor (CAR) and T cell receptor technologies (TCR) genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cells surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.