U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
Seraxis Inc. has obtained IND clearance from the FDA for a phase I/II study of its novel islet replacement therapy SR-02 for type 1 diabetes. SR-02 is comprised of allogeneic pancreatic endocrine cell clusters that, when implanted to the omentum, form a functional endocrine pancreas outside of the native pancreas.
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.”
This summer’s IPO by Artiva Biotherapeutics Inc. highlighted early stage efforts with natural killer cells in autoimmune disease, where a handful of companies are advancing programs. The firm raised $167 million through an upsized financing, with funds aimed at the development of its lead AlloNK program for systemic lupus erythematosus and other indications in the same category.
The Japanese government is throwing full weight behind the Bioeconomy Strategy initiative to position Japan’s biopharmaceutical industry as both a key driver of economic growth and global drug discovery hub.
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.”
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.”
Dark genome miner Enara Bio Ltd. has closed a $32.5 million series B that will see the lead program targeting the first of a novel class of cancer antigens it has discovered through to the clinic. Enara calls these cancer antigens “dark antigens” (the name is trademarked). It says they can be found in solid tumors irrespective of the immune phenotype, and are often expressed at high prevalence across multiple different tumors.
Dark genome miner Enara Bio Ltd. has closed a $32.5 million series B that will see the lead program targeting the first of a novel class of cancer antigens it has discovered through to the clinic. Enara calls these cancer antigens “dark antigens” (the name is trademarked). It says they can be found in solid tumors irrespective of the immune phenotype, and are often expressed at high prevalence across multiple different tumors.
Resolution Therapeutics Ltd. is preparing for a phase I/II trial of its autologous engineered macrophage cell therapy, RTX-001, in the treatment of end-stage liver disease and has raised £63.5 million (US$83.3 million) to complete the study and to add further fibrotic and inflammatory disease programs to its portfolio. Recruitment to the study, to be conducted at 15 sites in Spain and the U.K., is due to start before the end of 2024, with the monocyte-derived patient macrophages being processed and modified at a facility in Edinburgh.
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