Baxalta has signed a pact with gene-editing group Precision BioSciences to develop a broad series of allogeneic chimeric antigen receptor (CAR) T cell therapies that address major unmet need in multiple cancers.
Most CAR T cell therapy technologies are focused on isolating cells from cancer patients’ blood and manipulating them to specifically target receptors on tumour cells. These engineered cells are then multiplied in a lab and then returned to the patient to target the tumour.
The approach is already seeing early success in clinical trials for some tumour types, but because of the highly personalised nature of the therapy persistent scaling challenges remain.
The companies will employ Precision’s proprietary ARCUS genome editing technology that enables the production of CAR T cells derived from healthy donors rather than relying on the patient, in the hope of overcoming the manufacturing-related limitations with existing CAR T therapies.
Under the terms of the deal, Baxalta and Precision will develop CAR T therapies for up to six unique targets, with the first programme expected to enter clinical studies in late 2017. Precision is responsible for early-stage research up to Phase II, after which Baxalta has the exclusive right to opt in for late-stage development and commercialisation.
Precision will receive an upfront payment of $105 million from Baxalta, with additional option fees, developmental, clinical, regulatory, and sales milestones, potentially totalling up to $1.6 billion, in addition to royalties on worldwide sales.
“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,” noted David Meek, executive vice president and president, Oncology, Baxalta.