Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.
The cell and gene therapy sectors are growing exponentially, with new players emerging daily and much progress being made both in and out of the lab. CGTLive’s Around the Helix is your chance to catch up with the latest news in cell and gene therapies, including partnerships, pipeline updates, and more.
The FDA has accepted BioMarin’s resubmitted biologics license application (BLA) for valoctocogene roxaparvovec (val-rox) for review in treating severe hemophilia A.
Axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the European Commission for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) who are refractory to or have relapsed within 12 months 6of first-line chemoimmunotherapy.
Decibel Therapeutics’ DB-OTO, an investigational adeno-associated virus (AAV) dual-vector-based gene therapy intended to treat otoferlin-related hearing loss being developed in collaboration with Regeneron Pharmaceuticals, has received clearance from the FDA for its investigational new drug (IND) application, which was submitted last month.
The FDA has given investigational new drug application (IND) clearance to NKGen’s SNK02, an allogeneic natural killer (NK) cell therapy for treating solid tumors.
Akouos' lead investigational gene therapy, AK-OTOF, which is intended to treat otoferlin-gene related hearling loss, is a focal point of the acquisition.
The collaboration will aim to combine aCGT Vector's manufacturing platform with Xcell Biosciences' AVATAR AI platform for use in manufacturing and analyzing the potency of cell therapies directed at solid tumors.
BioMagnetic Solutions, a subsidiary of Gamma Biosciences, will supply its FerroSelect reagents to be utilized with Lonza's Coccoon manufacturing platform, with the aim of advancing the development of new CAR-T and other immunotherapeutic products.
Charles River Laboratories will provide its viral vector and plasmid DNA manufacturing services to support the advancement of Nanoscope's Multi-Characteristic Opsin optogenetic therapies.
The 2 technologies are still in early-stage development and are intended to address existing inefficiencies in the development of AAV vector-based gene therapies.
CLS001 conists of Corneal Endothelial Cell Substitute derived from induced Pluripotent Stem Cells and is intended to address the limited availability of corneal transplants for bullous keratopathy.
Bone Therapeutics has regained worldwide rights to the ALLOB platform, but Link Health has expressed continued interested in an agreement for the rights to ALLOB in Hong Kong, Macau, Taiwan, Singapore, South Korea, and Thailand.
The iTANK platform is intended to address difficulties with targeting solid tumors with CAR-T therapies. While it has intitially been used in Elicera's own CAR-T products, it was designed to be applicable to other CAR-T products as well.