TOKYO, Japan I January 10, 2017 I Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has entered into a strategic partnership with Kite Pharma (hereafter, Kite) for the exclusive rights of development, manufacturing and commercialization in Japan of Kite’s cellular cancer therapy axicabtagene ciloleucel (KTE-C19). The agreement also includes optional licensing rights for Kite’s chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates that will progress into the clinical development stage over the next three years.
Kite has built a pipeline for the research and development of autologous cellular immunotherapies* based on engineering the patient’s T cells to kill cancer cells more effectively.
KTE-C19 is an investigational form of autologous “chimeric antigen receptor T (CAR-T)” therapy directed against CD19, an antigen expressed in B-cell–related blood cancers, and is expected to prove beneficial for patients with aggressive B-cell lymphomas. Axicabtagene ciloleucel (KTE-C19) has been granted the Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of refractory aggressive B-cell lymphomas and a rolling submission of a Biologics License Application (BLA) was initiated with the FDA in December 2016. Axicabtagene ciloleucel (KTE-C19) has also been granted the Priority Medicines (PRIME) Designation for the treatment of chemorefractory diffuse large B-cell lymphoma (DLBCL) by the European Medicines Agency (EMA) in the EU.
In Japan, Daiichi Sankyo will be responsible for the development, commercialization and supply of axicabtagene ciloleucel (KTE-C19) after completing a technical transfer of manufacturing technology from Kite. Kite will have the responsibility for clinical manufacturing and supply until the completion of the technical transfer.
As a part of the agreement, Daiichi Sankyo will make an upfront payment of USD 50 million to Kite as well as additional payments for development and commercial milestones and sales royalties.
Kite has one of the most advanced technology platform in the field of engineered T-cell therapy, and with this strategic partnership Daiichi Sankyo hopes to offer a new treatment option to cancer patients in Japan.
*Cellular therapies are divided into two types: autologous therapy where the patient’s own cells are harvested, processed, cultured and then returned to the patient, and allogeneic therapy where a donor’s cells are processed, cultured and stored for the purpose of providing treatments to large numbers of patients.
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system’s ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
SOURCE: Daiichi Sankyo
Post Views: 18
TOKYO, Japan I January 10, 2017 I Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has entered into a strategic partnership with Kite Pharma (hereafter, Kite) for the exclusive rights of development, manufacturing and commercialization in Japan of Kite’s cellular cancer therapy axicabtagene ciloleucel (KTE-C19). The agreement also includes optional licensing rights for Kite’s chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates that will progress into the clinical development stage over the next three years.
Kite has built a pipeline for the research and development of autologous cellular immunotherapies* based on engineering the patient’s T cells to kill cancer cells more effectively.
KTE-C19 is an investigational form of autologous “chimeric antigen receptor T (CAR-T)” therapy directed against CD19, an antigen expressed in B-cell–related blood cancers, and is expected to prove beneficial for patients with aggressive B-cell lymphomas. Axicabtagene ciloleucel (KTE-C19) has been granted the Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of refractory aggressive B-cell lymphomas and a rolling submission of a Biologics License Application (BLA) was initiated with the FDA in December 2016. Axicabtagene ciloleucel (KTE-C19) has also been granted the Priority Medicines (PRIME) Designation for the treatment of chemorefractory diffuse large B-cell lymphoma (DLBCL) by the European Medicines Agency (EMA) in the EU.
In Japan, Daiichi Sankyo will be responsible for the development, commercialization and supply of axicabtagene ciloleucel (KTE-C19) after completing a technical transfer of manufacturing technology from Kite. Kite will have the responsibility for clinical manufacturing and supply until the completion of the technical transfer.
As a part of the agreement, Daiichi Sankyo will make an upfront payment of USD 50 million to Kite as well as additional payments for development and commercial milestones and sales royalties.
Kite has one of the most advanced technology platform in the field of engineered T-cell therapy, and with this strategic partnership Daiichi Sankyo hopes to offer a new treatment option to cancer patients in Japan.
*Cellular therapies are divided into two types: autologous therapy where the patient’s own cells are harvested, processed, cultured and then returned to the patient, and allogeneic therapy where a donor’s cells are processed, cultured and stored for the purpose of providing treatments to large numbers of patients.
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system’s ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
SOURCE: Daiichi Sankyo
Post Views: 18
