Allogene, Overland plot speedy Asia play for off-the-shelf CAR-T with $117M joint venture
David Chang got a good look at what it takes to bring CAR-T therapy to China and Asia markets when he and Arie Belldegrun struck a deal with Fosun Pharma to form a joint venture around its pioneering lymphoma treatment — which would come to be known as Yescarta — in 2017, just after submitting a BLA to the FDA.
With Allogene, the duo’s high profile startup aimed at delivering off-the-shelf CAR-T, he’s doing the same.
“With cell therapy, there is a continuous effort to employ the next generation technology and refine what we’re doing,” Chang told Endpoints News, explaining his reservations on a simple out-licensing model.
Allogene’s partner of choice is Overland Pharmaceuticals, the well-heeled Hillhouse startup that entered the stage just days ago and already unveiled a similar deal with ADC Therapeutics. Overland is pouring $117 million into Allogene Overland Biopharm, $40 million in the form of an upfront to Allogene and the rest injected straight into JV operations.
Contrast that with the $20 million that Fosun committed to set up shop with Kite, and you can deduce just how far the cell therapy space in China has come.
Hua Mu, interim CEO and CMO of Overland, would know. During his stint at WuXi AppTec before eventually landing a venture partner role at Hillhouse, he was involved in the discussions with Juno that eventually gave birth to JW Therapeutics — and despite the promising clinical data and clear need, both sides had questions. Juno made it clear they wouldn’t want to get in unless China started regulating CAR-T as a drug rather than medical technology; WuXi wasn’t entirely sure cell therapy is a viable class of medicine.
After a sweeping regulatory reform and a couple of FDA approvals later, the questions have now changed. The lead programs at Fosun Kite and JW are both under review in China with OKs expected imminently. It’s a matter of who can get it and how fast.
“So there’s no doubt about cell therapy as a viable new therapy,” Mu said. “The question is how to make it better, how to make it more applicable, how to make it more useful to address the unmet medical need.”
The promise of engineering healthy donor cells to replace the first-generation, personalized approach appeared to offer the answer. Lingering uncertainty regarding cell therapy importation means it will take time to sort out how precisely to get the drug material to patients, but the partners are also starting at an earlier stage of development.
Since Allogene’s lead program in BCMA has just generated initial Phase I data, Chang still sees opportunities to include come Chinese patients in its pivotal study down the line. Aside from that, it’s handed over three other cell therapy constructs targeting CD70, FLT3 and DLL3 to treat a number of both hematologic and solid tumors.
Overland has also secured rights in Taiwan, South Korea and Singapore, giving the company plenty to work on while talking to regulators and exploring local manufacturing in China.
Hillhouse’s presence in the region, spanning hospital networks, regulatory tact, clinical experience, CMC knowhow as well as sales and distribution muscle, was a big part of why Overland won over many other bidders after all.
For Overland, the kind of industrial scale production that allogeneic cell therapy enables — with each batch producing enough products for 100 patients and a turnaround time shrunk from weeks to days — fits well with the large, price-conscious market that it’s trying to address.
“From cost of manufacturing to efficiency, I think allogeneic brings a different ball game,” said Ed Zhang, who’s doubling as chief business officer and chief operating officer.
And if everything goes well, it will be ball game plays out in Asia almost in real-time as it does in the US and Europe.