Cell therapy weekly
Cell therapy weekly: preclinical programs for tumor-activated immunotherapies
This week: NecstGen (Leiden, Netherlands), a non-profit CDMO and biotechnology company Galapagos NV (Mechelen, Belgium) have partnered to advance decentralized manufacturing of CAR-T therapies, while Xilio Therapeutics (MA, USA) has collaborated with AbbVie (IL, USA) to develop tumor-activated immunotherapies. Plus, TG Therapeutics (NC, USA) enters a strategic platform license to prepare for the Phase I trial of Azercabtagene Zapreleucel.
NecstGen has announced a partnership with Galapagos NV to advance therapies and bridge the gap between the translation of research to clinical trials and increase accessibility of products to patients. The collaboration will combine part of NecstGen’s state-of-the-art facilities with Galapagos’ decentralized manufacturing platform, aiming to support decentralized production of CAR-T therapies.
Paul Bilars, CEO of NecstGen, stated: “Our collaboration with Galapagos marks an exciting milestone in the evolution of NecstGen as an organization and for cell and gene therapy manufacturing. By combining our state-of-the-art infrastructure with Galapagos’ decentralized cell therapy approach, we aim to provide capacity and support for decentralized manufacturing and make transformative therapies more accessible to patients who need them.”
Xilio Therapeutics, a clinical-stage biotechnology company developing tumor-activated immune-oncology therapies, has announced three preclinical masked T-cell engager programs and a partnership with AbbVie to develop novel tumor-activated immunotherapies, including masked T-cell engagers.
T-cell engagers direct immune cells to attack cancer cells by binding to both specific tumor antigens and T-cell receptor complexes. Xilio’s new programs target a prostate-specific membrane antigen, claudin 18.2, and a six-transmembrane epithelial antigen of prostate I, using its advanced tumor-activated cell engager and selective effector-enhanced cell engager formats to enhance T-cell activation and potency. Xilio will receive USD $52 million upfront, including $42 million in cash and a $10 million equity investment from AbbVie.
“T-cell engagers have demonstrated meaningful clinical activity, yet many promising targets for solid tumors remain out of reach due to toxicity limitations,” sad René Russo, President and CEO of Xilio. “Leveraging our clinically-validated masking technology, we aim to lead the next wave of innovation in cancer immunotherapy by developing masked T-cell engagers designed to improve tolerability through tumor-selective activation.”
MaxCyte (MA, USA) has entered a strategic platform license agreement with TG Therapeutics, granting TG Therapeutics access to MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. This agreement will support the development and commercialization of Azercabtagene Zapreleucel (azer-cel), an investigational allogeneic CD19 CAR T-cell therapy for autoimmune diseases.
TG Therapeutics previously secured a global license for the CAR-T cell therapy from Precision BioSciences (CA, USA) and has received U.S. Food and Drug Administration (MD, USA) clearance for an Investigational New Drug application to evaluate azer-cel in progressive multiple sclerosis. TG Therapeutics plans to launch a Phase I trial in 2025.
“Our technology has been integral to the manufacturing of allogeneic T-cell immunotherapies and was efficiently transferred from Precision BioSciences when TG Therapeutics obtained global rights for azer-cel for autoimmune diseases in January 2024,” said Maher Masoud, President and CEO of MaxCyte. “With our new partnership, we will continue to support the development of azer-cel to expand the application to autoimmune diseases.”
