In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for personalized treatments when a randomized trial isn’t feasible, as well as future uses of the approval path that could expand beyond gene and cell therapies to other biologics and even small molecules.
CEO Lynn Seely said Lyell Immunopharma Inc. is going “full steam ahead” with development of rondecabtagene autoleucel (ronde-cel, also known as LYL-314) amid the excitement of the firm’s latest news: the buy of global rights to LYL-273, an autologous guanylyl cyclase-C-targeted CAR T-cell candidate for metastatic colorectal cancer (mCRC), from Innovative Cellular Therapeutics Inc. (ICT) for an up-front payment of $40 million and 1.9 million shares of Lyell common stock.
Brainxell Inc. has reported preclinical data demonstrating efficacy of BXT-110, an autologous induced pluripotent stem cell (iPSC)-derived neuronal therapy for Parkinson’s disease.
Stem cells are a promising therapeutic modality to fight aging and age-related disease, speakers at the Bio-Plus Interphex Korea 2025 said. Progress in cell-based longevity medicine is being made, they added, although safety, ethical and regulatory issues are ongoing challenges.
Durable reprogramming of human T cells may now be possible thanks to a new technique based on the CRISPRoff and CRISPRon methodology. Researchers from the Arc Institute, Gladstone Institutes, and the University of California San Francisco have stably silenced or activated genes in this type of immune cell without cutting or altering its DNA, making T cells more resistant, active, and effective against tumors.
Researchers at the University of California, Los Angeles (UCLA), have developed a new type of allogeneic immune cell therapy that demonstrated potent antitumor activity against triple-negative breast cancer (TNBC) in preclinical studies.
Stem cells are a promising therapeutic modality to fight aging and age-related disease, speakers at the Bio-Plus Interphex Korea 2025 said. Progress in cell-based longevity medicine is being made, they added, although safety, ethical and regulatory issues are ongoing challenges.
In a recent publication in iScience, researchers from Peking University First Hospital investigated the therapeutic potential of SLC7A11 CAR T therapy for solid tumors, particularly colorectal and pancreatic cancers.
Durable reprogramming of human T cells may now be possible thanks to a new technique based on the CRISPRoff and CRISPRon methodology. Researchers from the Arc Institute, Gladstone Institutes, and the University of California San Francisco (UCSF) have stably silenced or activated genes in this type of immune cell without cutting or altering its DNA, making T cells more resistant, active, and effective against tumors.
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