Indee Labs announced the publication of a proof-of-concept study demonstrating the efficacy of its gene-modified cell therapy (GMCT) development and manufacturing technology in Nature’s Scientific Reports. The study was completed in collaboration with the University of Southern California Norris Comprehensive Cancer Center, the University of Sydney Medical School, and the University of South Australia Future Industries Institute. The novel microfluidic method of intracellular delivery could provide a solution to one of the most significant challenges faced by the industry: scalability.
Unlike traditional medicines, GMCTs are made from patient and donor cells, which have been modified with the introduction of new genetic material. Issues surrounding the most critical step in their manufacture, the delivery of new genes into cells, have held back both the pace of development of new treatments and scaled manufacturing of approved therapies such as CAR-T. Most commonly this step is performed using engineered viruses; however, the GMCT market has been searching for non-viral alternatives due to supply challenges, costs, and other technical issues.
“We were able to efficiently deliver mRNA to primary human T cells with high yield and negligible perturbation to T cell function, viability, and growth,” stated lead author and translational immunologist Justin Jarrell, PhD. “The recent literature indicates reducing ex vivo culture and preserving native T cell states prior to administration results in more effective gene-modified T cells in vivo.”
As reported in the paper “Intracellular delivery of mRNA to human primary T cells with microfluidic vortex shedding,” Indee Labs scientists successfully delivered an mRNA construct into human T cells with high yield (i.e. transfection efficiency, cell viability, and cell recovery) and negligible perturbation to the T cell state, at a speed and scale that rivaled or exceeded conventional methods.
“Current in vitro and ex vivo intracellular delivery methods fail to meet the practical needs of GMCT development and manufacturing,” said Ryan S. Pawell, CEO of Indee Labs (USA). “Our results indicate that microfluidic vortex shedding is an excellent alternative with promising attributes for discovery-stage research, clinical development, and commercial manufacturing of engineered or gene-modified human T cells. µVS is also already in development for a range of cell engineering methods outside of mRNA delivery to T cells.”
Dr. Warren McKenzie, CEO of Indee Labs (Australia), added: “We believe we have demonstrated a scalable gene-delivery technology for GMCT development and manufacturing that does not damage immune cells. Further, we are already working towards clinical development with multiple cell therapy clinics in both Australia and the United States.”
Other advantages of the μVS method include reduced costs, ease-to-scale, and substantially shorter lead times compared to clinical and commercial GMCT manufacturing using viruses.
Dr. McKenzie added: “GMCTs will, in the future, provide curative therapies for many people who today would be considered terminal cancer patients and other indications. With almost 4,000 new GMCTs in clinical trials around the world, their impact could be comparable to the advent of antibiotics during the last century.”
About Indee Labs
Indee Labs is developing scalable hardware for gene delivery using microfluidic vortex shedding (µVS). The team has already demonstrated revolutionary improvements over existing gene delivery methods including higher yield, negligible immune cell perturbation along with rapid processing of research-, clinical- and commercial-scale samples with a simple workflow and a small footprint. These promising early results have led to seed investment from investors in both Australia (Main Sequence Ventures) and the United States (Y Combinator, Social Capital and Founders Fund). Indee Labs would like to hear from biotechnology and pharmaceutical companies developing gene-modified cell therapies interested in trialing µVS gene delivery. More information at www.indeelabs.com.
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