Cell therapy weekly: T-cell testing kit for safer cell therapies
This week: CellFE (CA, USA) launched T-Rest™, a first-in-class T cell kit for CAR-T cell therapy manufacturing and the US Food and Drug Administration (FDA; MD, USA) issued a Fast Track designation for Solid Biosciences’ (MA, USA) AAV-based gene therapy for Friedreich’s ataxia. Plus, a partnership has formed between Cellipont Bioservices (TX, USA) and Secretome Therapeutics (TX, USA) to manufacture a lead product cell therapy candidate.
The news highlights:
- T cell testing kit for safer cell therapies
- Fast Track designation for Friedreich’s ataxia gene therapy
- Partnership for cell therapy manufacturing
T-cell testing kit for safer cell therapies
CellFE has introduced the CellFE T-Rest, a transfection media product designed for resting T-cell workflows, aimed at addressing durability and safety challenges in cell therapy manufacturing. T-Rest enables a fully optimized gene editing process using resting T cells as the starting material.
“We’re thrilled to launch T-Rest – the first-in-class resting T-cell commercial product – to offer a new paradigm for cell therapy manufacturing,” expressed Alla Zamarayeva, CEO of CellFE. “By enabling efficient editing of resting T cells, we address the durability and safety concerns that currently challenge cell therapy manufacturers.”
Fast Track designation for Friedreich’s ataxia gene therapy
The FDA has granted Fast Track designation to Solid Biosciences’ AAV-based gene therapy, SGT-212, for the treatment of Friedreich’s ataxia. This therapy aims to deliver the complete frataxin gene through both intradentate nucleus and intravenous infusions, aiming to restore therapeutic levels of the frataxin protein to improve the symptoms of the disease.
“SGT-212 is the only [Friedreich’s ataxia] therapy in development that is designed to address frataxin deficiency, the underlying cause of [Friedreich’s ataxia’s], and all manifestations of this devastating disease, and in doing so, hopefully halt the full spectrum of symptom progression regardless of where the patient is in their journey with this terrible disease,” explained Bo Cumbo, President and CEO of Solid Biosciences. “We believe Fast Track designation may enable us to more rapidly develop SGT-212 and bring hope to those living with [Friedreich ataxia] who need and deserve better treatment options.”
Partnership for cell therapy manufacturing
Cellipont Bioservices and Secretome Therapeutics have formed a partnership to manufacture STM-01, a novel cell therapy for cardiovascular diseases. As part of this collaboration, Cellipont Bioservices will be responsible for technology transfer, analytical method transfer and cGMP manufacturing for the STM-01 Master Cell Bank. STM-01 is protected by a recently issued composition of matter patent, which also includes STM-21, the lead secretome-based therapeutic developed by Secretome.
“A key objective for Secretome in 2025 is to produce STM-01 drug product that is suitable for late-stage clinical testing and potential commercial use,” said Vinny Jindal, President and CEO of Secretome Therapeutics. “Cellipont’s world-class facility and deep expertise in cGMP manufacturing for cell and gene therapies make them an ideal manufacturing partner and align perfectly with our mission to deliver transformative therapies for cardiovascular diseases and beyond.”
