— Multi-center, pivotal Phase 2 trial to begin in the near term —
SEATTLE, WA, USA I July 30, 2015 I Juno Therapeutics, Inc. (JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced 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). 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.
“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.
About Juno Therapeutics, Inc.
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling evidence of tumor shrinkage in the clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to improve and leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute.
SOURCE: Juno Therapeutics
Post Views: 82
— Multi-center, pivotal Phase 2 trial to begin in the near term —
SEATTLE, WA, USA I July 30, 2015 I Juno Therapeutics, Inc. (JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced 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). 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.
“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.
About Juno Therapeutics, Inc.
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling evidence of tumor shrinkage in the clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to improve and leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute.
SOURCE: Juno Therapeutics
Post Views: 82
