As allogeneic cell therapy approaches flourish, Century loads up $160M to scale iPSC platform for CAR-T, CAR-NK
Lalo Flores is confident he’s found the way forward in cell therapy.
The feeling, to be sure, is not exclusive. Thanks to splashy companies like Allogene and Artiva, biopharma is well aware of the promises of allogeneic therapies as next-generation alternatives to the autologous CAR-Ts that have already made it to the market. But fewer are talking about a finer distinction within that allogeneic group: Where do you find the cells to engineer and turn into a final off-the-shelf product?
While most have opted for donor cells, Century Therapeutics — where Flores is CEO — is banking on induced pluripotent stem cells.
Almost two years after launching with $250 million in cash and three employees, it’s collected $160 million to fuel the now 100-person team’s dash to the clinic.
In parallel with all the advances in cell engineering over the years, there’s been a similar evolution in the science of reprogramming skin or blood cells into an embryonic-like state and coaxing them into T or NK cells. Fate Therapeutics, a J&J-partnered pioneer now in the clinic, has done much to educate the field about it, and more recently we’ve seen startups like Notch emerge; Century wants to join them in the leading spot, Flores said.
The room for improvement, after all, is significant. Even in the few lymphoma indications where Kymriah and Yescarta have been approved, not all patients achieve a complete response and many who do would relapse.
“So clearly what that means is that there was not enough pressure on the tumor, there were enough cells that survived that treatment […] and that’s the reason patients relapse,” Flores said. “Our goal at Century is to increase the durability of the responses.”
Century is “platform agnostic” and therefore developing both CAR-T and CAR-NKs created with its iPSCs. The lead program is a CD19 CAR-T that they hope to steer into a human trial by 2022.
In addition to the antigen targets, the biotech has devised a combination of three genetic edits to prevent immune rejection of the therapeutic cells — opening up the possibility to dose several times until the patient responds.
With each new program, once they finalize all the modifications Century would isolate a single clone to start what they call a master cell bank.
“It may take you a couple of years to get to that point,” Flores said. “But once you have a master cell bank, that is the beginning of your manufacturing process. And from there it only takes you 30 days to make a manufacturing run that will supply thousands of doses.”
Ultimately, he envisions Century’s therapies to be stored as a frozen product in hospitals. The preclinical pipeline goes after a slate of hematological malignancies as well as solid tumors like glioblastoma, where they would deploy a bispecific CAR. The substantial backing from Versant and Bayer in its Series B has helped Flores recruit a experts in protein engineering, gene editing and manufacturing, with him managing the headquarters in Philadelphia, R&D chief Hyam Levitsky leading a team in Seattle and the group that was formerly Empirica Therapeutics setting up a third office in Canada after Century acquired the company.
More recently, it’s leased the space for an manufacturing facility in New Jersey, just 45 minutes from the HQ, adding in-house capacity to complement the existing production under a partnership with Fujifilm Cellular Dynamics.
“Each time you develop a product, you begin the whole process of learning how to scale up manufacturing,” he said. “Going to this journey, there’s many learnings and it’s really important to capture all those learnings within your own employees, your own scientists, or within your close partner as we have in FCDI.”
They could be taking those learnings to Nasdaq soon. Though Flores notes Century now has two to three years of runway, the Series C syndicate — Fidelity, the Federated Hermes Kauffman Funds, RA Capital, Logos Capital, OrbiMed, Marshall Wace, Qatar Investment Authority, Avidity Partners, and Octagon Capital — features well-known crossover players with whom he will be exploring an IPO.