CAR-T manufacturing potential moves to Asia

RANCHO CORDOVA, Calif.—Immuno-oncology is one of the more promising area of cancer treatment right now, with encouraging findings in CAR-T cell therapy, stem cell therapy, monoclonal antibodies and more. CAR-T in particular has shown impressive clinical results for a variety of cancer types, with the promise of more success with further study. The drawback to CAR-T is the cost, which ranges from $100,000 to $475,000 per patient. The high costs are due to the highly individualized, labor-intensive process currently in use, whereby a single dose can take days or weeks to manufacture.

 

Cesca Therapeutics, specializing in automated cell processing and point-of-care, autologous cell-based therapies, boosted its profile in the T cell production arena in 2017 through the acquisition of SynGen and its X-Series cellular processing technology, promising a faster, cheaper way for large-scale manufacturing of CAR-T cells. The X-Series offers a modular platform of various devices that automate different parts of the process, allowing for increased productivity in washing, separating and producing cells and corresponding doses. Their processes are magnet-free and Ficoll-free, while delivering faster processing time with a higher volume of recoverable cells after the manufacturing process.

 

In order to capitalize on their improved capacity in the CAR-T space in China, which is home to about 50 percent of CAR-T studies, Cesca’s ThermoGenesis subsidiary has recently signed a licensing agreement with IncoCell Tianjin Ltd., a Chinese company dedicated to the contract development and manufacture of cellular products for immuno-oncology. Under the terms of the agreement, IncoCell is granted an exclusive license to purchase and use, at a discount, the X-Series cellular processing research devices, consumables and kits. This will enable IncoCell to expand its contract development and manufacturing organization (CDMO) operations throughout the Asian-Pacific region, including China, Japan, South Korea, Taiwan, Hong Kong, Macau, Singapore, Malaysia, Indonesia and India. For its part, ThermoGenesis is entitled to a percentage of IncoCell’s gross contract development revenues, including any potential upfront payments, future milestones or royalty payments.

 

“China is among the leading markets for CAR-T developers, and together with the U.S., represent the two countries with the highest number of ongoing CAR-T clinical trials,” said Dr. Chris Xu, CEO of Cesca. “This agreement with IncoCell signifies our first CDMO collaboration and is consistent with our goal of expanding beyond off-the-shelf cellular processing solutions into higher-value contract manufacturing and development services. Moving forward, we plan to pursue additional CDMO collaborations in selected markets while executing global distribution and other strategic partnering agreements for our highly differentiated X-Series line of products.”

 

IncoCell is wholly owned by Chinese giant Boyalife Group, which is also the majority shareholder of Cesca. Benefits for all parties stem from Boyalife ownership of manufacturing facilities in Asia that will allow for increased efficient production of CAR-T cells in Asia, protecting cell lines and facilitating transport throughout the region—getting Cesca in the Asian market without having to build facilities.

 

According to Cesca Senior Vice President of Corporate Development Joseph Balagot, the future for Cesca involves finding manufacturing partners in the United States to generate the same potential as the IncoCell deal presents in China.

 

“There are over 450 active studies involving CAR-T currently underway, and the biggest challenge many of them face is on the manufacturing side,” asserts Balagot. “We hope to partner with academic institutions and other industrial players to create a higher-value patented approach to CAR-T manufacturing. We are actively seeking global distribution partners to help us broaden this unique and essential category of manufacturing.”