China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
Bristol-Myers Squibb Co. has released top-line phase III results from its CAR T therapy Breyanzi (lisocabtagene maraleucel) that could support its use earlier in patients with refractory large B-cell lymphoma, outperforming standard stem cell transplant therapy.
While acknowledging the net health benefit over standard of care in heavily pretreated multiple myeloma patients, CAR T-cell therapies Abecma (idecabtagene vicleucel) and ciltacabtagene autoleucel (cilta-cel) represent low long-term value at their current pricing levels, according to the Institute for Clinical and Economic Review (ICER) in a final evidence report released May 11.
HONG KONG – The Korea Advanced Institute of Science and Technology (KAIST) is making headway with its 3D holotomography technology, which enables a more accurate and systematic way to view cell-to-cell interactions. This could be a game changer for assessing cell therapy.
HONG KONG – Daejeon, South Korea-based Curocell Inc. has received the first IND approval for a CAR T therapy in South Korea from the Ministry of Food and Drug Safety (MFDS).
PERTH, Australia – Chimeric Therapeutics Ltd. closed an IPO on the Australian Securities Exchange (ASX:CHM), raising AU$35 million (US$26.5 million) to fund its CAR T trial in glioblastoma.
Biofourmis Inc. scooped up $100 million in a series C round that was led by Softbank Vision Fund 2. The funds are earmarked to accelerate U.S. and global expansion of Biofourmis’ artificial intelligence (AI)-powered health analytics platform and to advance its pipeline of digital therapeutics. The company focuses software-based therapeutics and AI tools for personal predictive care and has U.S. FDA-cleared products that aim to boost clinicians’ ability to remotely monitor and treat patients.
HONG KONG – Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.
HONG KONG – Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.
