TG Therapeutics has established a strategic partnership with MaxCyte to advance the development of its promising CAR T-cell therapy candidate, azercabtagene zapreleucel (azer-cel), for adults with progressive forms of multiple sclerosis (MS). The collaboration grants TG Therapeutics access to MaxCyte's advanced flow electroporation technology and ExPERT platform, essential tools for scaling up the production of engineered T-cells for clinical applications.
Strategic Technology Partnership Details
The agreement involves TG Therapeutics making annual payments and sharing earnings in exchange for MaxCyte's proprietary cell-engineering platform. Maher Masoud, MaxCyte's president and CEO, emphasized the significance of the partnership, stating, "By leveraging our commercially validated cell-engineering platform and optimized T cell manufacturing workflow, TG Therapeutics is advancing toward their Phase 1 clinical trial for the application of azer-cel in progressive forms of MS."
Innovative Therapeutic Approach
Azer-cel represents a novel approach to MS treatment, targeting the underlying autoimmune mechanisms of the disease. The therapy utilizes T-cells from healthy donors, which are engineered to express a chimeric antigen receptor (CAR) targeting CD19, a protein present on B-cells. This approach differs from traditional CAR T-cell therapies that rely on patient-derived cells.
The therapeutic mechanism centers on eliminating B-cells responsible for producing self-reactive antibodies that attack the myelin sheath surrounding nerve cells. Importantly, azer-cel's design includes features to prevent graft-versus-host disease, a common concern with donor-derived cell therapies.
Phase 1 Clinical Trial Overview
The upcoming Phase 1 trial (NCT06680037) will evaluate azer-cel in 32 patients aged 18-60 with progressive forms of MS, including both primary progressive and secondary progressive variants. The study's primary objective is to establish the optimal dose for Phase 2 trials by monitoring dose-limiting toxicities over a 28-day period following a single intravenous administration.
Development Timeline and Rights
This development follows TG Therapeutics' acquisition of azer-cel's rights from Precision BioSciences in early 2024 for autoimmune disease applications. The U.S. Food and Drug Administration has already granted clearance to begin clinical testing, with initial recruitment potentially underway in Lexington, Kentucky.
Manufacturing and Scale-up Strategy
MaxCyte's technology platform will play a crucial role in ensuring consistent and scalable production of the therapy. The successful technology transfer from Precision BioSciences to TG Therapeutics has already been completed, establishing a foundation for efficient manufacturing processes as the therapy advances through clinical development.
