If the cell therapy field in the US is just getting started with two commercial CAR-T players, China represents an even bigger untapped market for James Li, the CEO of JW Therapeutics.
“The whole space is wide open,” he said.
His company, a joint venture created by Juno and WuXi AppTec, has been at the heels of its US counterparts. It has a BLA at China’s drug regulators for the lead program targeting CD19, a revised version of Juno’s JCAR017; is developing a BCMA therapy to follow; and more recently got into NK cells. The team, consisting of 200-plus employees, covers everything from process development and manufacturing to regulatory affairs and quality control.
But there are some things it’s lacking: JW wanted to get into the solid tumor space, and it has little expertise in early-stage development, where it’s been relying extensively on Juno (later Celgene, now Bristol Myers Squibb).
It’s now filled both those gaps by buying out Syracuse Biopharma, the Chinese subsidiary of Bay Area-based Eureka Therapeutics.
“We want to build the leading T cell therapy company in China; it has to have a discovery capability,” Eureka founder and president Cheng Liu told Endpoints News.
Liu noted that Eureka’s connection with Juno dates back to 2016, when it licensed three Memorial Sloan Kettering-partnered binding domains to the CAR-T player to develop treatments for multiple myeloma, including one for BCMA.
Since then his staff has been solely focused on solid tumors, leveraging TCR mimic antibodies and another secretive technology that helps T cells infiltrate tumors to hone in on liver cancer. The antibodies promise to recognize targets inside tumor cells and bind to them with higher affinity than general receptors. A clinical proof-of-concept study conducted in China two years ago suggested a “surprising” impact; the biotech is now planning an official Phase I in the US.
The deal with JW — which Liu views as a merger — will put them on a path to file an IND in China. The construct used in the 2018 trial “was two generations ago in terms of technology,” Li said, so they will be taking the new candidate into trials.
Don’t look for them to rush it. Having watched the drug industry evolve as Amgen’s founding general manager in China, Li doesn’t see cell therapy getting crowded like PD-1 did, with over a dozen companies all clamoring to make the same drug. Not only do you need differentiation — some biotechs are getting creative trying to stand out — you also need to be consistent with creating the products.
“What people don’t realize is it takes a much longer time actually if you want to have a commercially viable process, to have something meaningful you can commercialize,” he said.
The costs associated with building out the infrastructure means collaboration and M&A will be the way to go.
“We just started a trend,” he said, “but I think more will be coming.”