AstraZeneca is acquiring cell therapy developer Gracell Biotechnologies Inc. for $1.2B. Gracell is focused on cancer and autoimmune diseases and, importantly, has a toehold in China. The biotech has ten programs in preclinical or later phases. Its most advanced candidate, GC012F, is in Phase I/II trials in the U.S. and cleared for Phase I/II in China for relapsed or refractory multiple myeloma.
Gracell writes, on their website, that they “partner with top-tier hospitals in China to streamline the safety and efficacy testing of our innovative pipeline product candidates in investigator-initiated trials that are conducted in accordance with international standards.”
The biotech develops both autologous CAR-T and and allogeneic treatments. They also have a proprietary “2nd generation enhanced CAR-T” that specially targets solid tumors.
GC012F is a B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T. Targeting BCMA was one of the earliest CAR-T strategies and resulted in treatments Abecma (idecabtagene vicleucel) and Carvkti (ciltacabtagene autoleucel), which have delivered remarkable response depths and durations among patients with highly refractory myeloma. CD19 is another popular target for CAR-T, with several drugs approved.
Besides being a candidate for multiple myeloma, GC012F is being tested in other hematologic malignancies and autoimmune diseases including systemic lupus erythematosus.
Gracell says its FasTCAR platform significantly shortens manufacturing time, enhances T cell fitness, and will potentially improve the effectiveness of autologous CAR-T treatment in patients. Future applications of this technology may also include rare diseases.
Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said, “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. 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.”
William Cao, founder, Chairman and CEO, Gracell, said, “By combining our expertise and resources, we can unlock new ways to harness the Gracell FasTCAR manufacturing platform, which we believe has the potential to optimize the therapeutic profile of engineered T cells, to pioneer the next generation of autologous cell therapies.”
Gracell will operate as a wholly owned subsidiary of AstraZeneca, with operations in China and the U.S.
The upfront cash portion of the transaction is worth approximately $1.0B. Combined, the upfront and potential contingent value payments represent a transaction value of approximately $1.2B, an 86% premium to Gracell’s closing market price on December 22, 2023.
AstraZeneca has expanded their activity in hematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion. By targeting hematologic conditions with high unmet medical needs, AstraZeneca, “aims to deliver innovative medicines and approaches to improve patient outcomes.” The company says its focus is “on some of the most challenging cancers,” and that it has “built one of the most diverse portfolios and pipelines in the industry.”