AstraZeneca pays $1B to take the wheel of Gracell’s CAR-T ‘fast car’

While you could forgive Big Pharma for backing away from CAR-Ts in the wake of the FDA’s decision to investigate the risk of secondary cancers, AstraZeneca has decided that a cell therapy company would make the perfect Christmas present.

The Big Pharma is paying $1 billion to acquire Gracell Biotechnologies. The China-based biotech’s pipeline is headed up by GC012F, a BCMA and CD19 dual-targeting autologous CAR-T that is being tested in a phase 1b/2 trial in relapsed refractory multiple myeloma in the U.S., as well as a trial in China for refractory systemic lupus erythematosus.

GC012F has been developed using the company’s FasTCAR platform, which is designed to cut down manufacturing time as well as enhance T cell fitness in order to improve the effectiveness of treatments in patients. Looking further ahead, AstraZeneca suggested that “future applications of this [FasTCAR] technology may also include rare diseases.”

The biotech has three other candidates listed in its pipeline, although none have yet entered the clinic. They include GC509, a dual-targeting CAR-T also using the FasTCAR tech that is being lined up for acute myeloid leukemia. Then there is the CD19 and CD7-focused GC502 and the BCMA and CD7-focused GC508—for leukemia and myeloma, respectively—that have been developed with the company’s TruUCAR platform.

The deal, which is due to close in the first quarter of 2024, will see Gracell operate as a wholly-owned subsidiary of AstraZeneca, with operations in China and the U.S. The Big Pharma has agreed to pay $2 per share of the Nasdaq-listed company, along with a contingent value right of 30 cents a share if certain regulatory milestones are reached.

The $1 billion price tag marks a 62% premium on the biotech’s $6.19 share price at market close on Friday, AstraZeneca noted.

While AstraZeneca has been a major player in the oncology space, the company was noticeably absent as the first wave of CAR-T therapies hit the market over the past few years. However, execs told Fierce Biotech last year that the company had been quietly stockpiling the necessary knowledge and technology to make an AstraZeneca CAR-T a reality one day.

While those ambitions stretched to tackling solid tumors with “off-the-shelf” cell therapies, the deal with Gracell covers more familiar ground of autologous CAR-Ts that are already being tested in various blood cancers. And while AstraZeneca has been behind some large acquisitions and licensing deals in recent months, including buying RSV vaccine developer Icosavax for $800 million earlier in December, the company had rarely strayed into CAR-T territory apart from licensing a glypican 3 armored CAR-T from AbelZeta Pharma.

“The proposed acquisition of Gracell will complement AstraZeneca’s existing capabilities and previous investments in cell therapy, where we have established our presence in CAR-T and T-cell receptor therapies (TCR-Ts) in solid tumors,” Susan Galbraith, EVP of Oncology R&D at AstraZeneca, said in the Dec. 26 release.

“GC012F will accelerate our cell therapy strategy in hematology, with the opportunity to bring a potential best-in-class treatment to patients living with blood cancers using a differentiated manufacturing process, as well as exploring the potential for cell therapy to reset the immune response in autoimmune diseases,” Galbraith added.

CAR-Ts have hardly been flavor of the month ever since the FDA announced at the end of November that it will investigate the “serious risk” of subsequent, secondary cancers that can occur after treatment with the therapies. The agency said it had received reports of T-cell malignancies—including CAR-positive lymphoma—among patients who received BCMA- or CD19-directed CAR-T immunotherapies, with some patients hospitalized or later dying.