The Leukemia & Lymphoma Society (LLS) will partner with Kite Pharma in developing the company’s lead product candidate KTE-C19 for patients with refractory aggressive non-Hodgkin lymphoma.
As part of their collaboration, the partners said today, LLS will chip in up to $2.5 million through its Therapy Acceleration Program (TAP) to help fund Kite's ongoing Phase I/II clinical study of KTE-C19 (NCT 02348216). The study was recruiting patients as of May 19, the date of the most recent update posted on ClinicalTrials.gov.
The trial is designed to evaluate safety and efficacy in the treatment of patients with refractory diffuse large B cell lymphoma, as well as two rare lymphomas—primary mediastinal B cell lymphoma and transformed follicular lymphoma.
Pivotal results from the KTE-C19 study are expected in 2016. Should those results prove promising, they could lead to the potential launch and commercialization of KTE-C19 in 2017, the partners said.
Kite also plans to launch three additional trials of KTE-C19 before the end of this year. The trials will assess the gene therapy candidate’s in mantle cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia, Kite and LLS said.
Based on the progress of the KTE-C19 development program, Kite agreed to make an undisclosed amount of milestone payments to LLS, and offer financial support to the society for its rollout of the education program.
“LLS is committed to supporting the development of potentially curative therapies for patients diagnosed with blood cancers, and we view KTE-C19 as a candidate with great potential for patients with lymphoma who have limited treatment options,” LLS president and CEO Louis J. DeGennaro, Ph.D., said in a statement.
Through TAP, LLS aims to speed up the development of innovative blood cancer treatments, supportive care, and diagnostics. TAP identifies and funds projects related to therapies, supportive care, or diagnostics that according to the society have the potential to change the standard of care for patients with blood cancer, especially in areas of high unmet medical need.
According to LLS, TAP funding is designed to help clinical investigators and companies generate clinical proof of concept data in order to obtain additional resources. The society says the program can also help companies find a partner to help carry out testing, registration, and marketing of new treatments, supportive care, and diagnostics for leukemia, lymphoma, and myeloma.
KTE-C19 is an investigational therapy in which a patient's T cells are genetically modified to express a chimeric antigen receptor designed to target the protein CD19, expressed on the cell surface of B cell lymphomas and leukemias.