Yescarta™ is positioned to join Kymriah™ as the second chimeric antigen receptor T cell (CAR-T) therapy to achieve regulatory approval in Canada, based on exciting news released this month from Gilead Sciences Canada. [Read more…]
Kymriah® (tisagenlecleucel), CAR-T therapy from Novartis, receives TGA approval for treating two aggressive blood cancers
- Kymriah® is an immunocellular therapy that is a one-time treatment manufactured individually for each patient using the patient’s own T cells, genetically reengineered and programmed to recognise and destroy cancer cells.
- Kymriah® is approved for the treatment of relapsed or refractory patients with paediatric B-cell acute lymphoblastic leukaemia (ALL) and adult diffuse large B-cell lymphoma (DLBCL)
- Kymriah® could be a treatment option for about 50 paediatric and young adult ALL patients and 420 adult DLBCL patients who relapse or do not respond to initial therapy
- Kymriah® is the only chimeric antigen receptor T cell (CAR-T) therapy to receive TGA approval in Australia
LAKEWOOD, Colo., Oct. 09, 2018 — Shanghai UniCAR-Therapy Bio-Medicine Technology Co. chose Terumo BCT and its cell expansion devices to automate its cell therapy manufacturing process for chimeric antigen receptor (CAR) T-cell therapies. Privately held, UniCAR will open their Center of Excellence for Terumo BCT’s technologies in Shanghai in November.
Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular therapy technologies. The company provides flexible solutions for CAR T-cell developers and manufacturers, including the Quantum® Cell Expansion System, in use at UniCAR today. [Read more…]
Option-based Collaboration to Develop Two CAR T-Cell Product Candidates Using Fate’s Proprietary iPSC Product Platform
SAN DIEGO, Sept. 17, 2018 — Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that it has entered into a collaboration with ONO Pharmaceutical Co., Ltd. for the joint development and commercialization of two off-the-shelf CAR-T cell product candidates. Using Fate Therapeutics’ proprietary induced pluripotent stem cell (iPSC) product platform, the two CAR T-cell collaboration candidates will each be derived from a clonal master iPSC line engineered to completely eliminate endogenous TCR expression, insert a chimeric antigen receptor (CAR) into the TRAC locus and incorporate other anti-tumor functionality. [Read more…]