Baxalta and Precision BioSciences said today they will partner to develop allogeneic chimeric antigen receptor T cell (CAR-T) therapies, in a collaboration that could generate up to $1.7 billion for Precision.
The companies said their collaboration will combine Baxalta’s immuno-oncology candidates and global-scale operations with Precision’s ARCUS genome editing platform technology. The CAR-T cell therapies will address what Baxalta and Precision called areas of major unmet need in multiple unspecified cancers.
Oncology is one of three areas of therapeutic focus for Baxalta, which had been known as Baxter BioScience until Baxter International spun out the global biopharmaceutical business last year. The other two are hematology and immunology.
ARCUS is designed to enable the production of CAR-T cells derived from healthy donors rather than from patients. Precision says the platform is aimed at surmounting manufacturing-related limitations with existing CAR-T therapies while allowing a broader range of malignancies to be targeted.
“Combining Precision BioSciences’ ARCUS technology with Baxalta’s global infrastructure, expertise, and growing immuno-oncology portfolio is a synergistic approach that we believe has the potential to make disruptive approaches available to people with a range of underserved cancers,” David Meek, Baxalta evp and president, oncology, said in a statement.
Baxalta and Precision agreed to develop CAR-T therapies for up to six undisclosed targets, with the first program expected to enter clinical studies in late 2017.
Precision agreed to oversee early-stage research activities up to Phase II, after which Baxalta has the exclusive right to opt in for late-stage development and commercialization. In return, Baxalta agreed to pay Precision $105 million upfront, followed by up to $1.6 billion in option fees and payments tied to achieving developmental, clinical, regulatory, and sales milestones, in addition to royalties on worldwide sales.
Precision holds rights to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the U.S.
Baxalta’s collaboration with Precision is its second potentially billion-plus dollar immuno-oncology partnership launched this year. Last month, Baxalta agreed to co-develop Symphogen’s early-stage immuno-oncology programs, in an alliance that could generate up to $1.6 billion for Symphogen—and expanded the Baxter spinout’s oncology portfolio into cancer immunotherapies.