NEW YORK – AstraZeneca has selected an autologous T-regulator (Treg) cell therapy candidate from Quell Therapeutics' pipeline to advance into preclinical and clinical trials in type 1 diabetes, triggering a $10 million option exercise payment under a 2023 collaboration deal between the two firms.
In a statement on Monday, London-based Quell said this was the first research milestone it has achieved under the exclusive option and license agreement it inked with AstraZeneca last year for the development of engineered Treg cell therapies for treating type 1 diabetes and inflammatory bowel disease. In the deal, AstraZeneca paid Quell $85 million upfront in cash and through an equity investment and Quell is eligible to receive more than $2 billion in development and commercialization milestones, as well as tiered royalties.
AstraZeneca will now conduct clinical trial application- and investigational new drug-enabling studies and clinical trials involving the selected candidate. Quell will provide chemistry, manufacturing, and controls support for the preclinical studies and supply the selected drug under good manufacturing practices protocols for a first-in-human trial. Under the terms of its deal with AstraZeneca, Quell has the option to co-develop this type 1 diabetes therapy candidate in the US, in exchange for additional milestone payments and increased royalties on US net sales.
"Type 1 diabetes can be challenging for patients in terms of long-term disease management and impact on quality of life, with no options for disease-modifying therapies," Regina Fritsche Danielson, SVP and head of early R&D within AstraZeneca's cardiovascular, renal, and metabolism division, said in a statement. "Our ambition with this CAR-Treg program is to harness the body's immune system to target disease drivers in type 1 diabetes and potentially slow or stop disease progression."
Quell engineers its cell therapies using a patient's own Treg cells ex vivo, which are introduced to the body to address inflammation and tissue destruction. The company is internally developing the autologous Treg cell therapy candidate QEL-001. In the ongoing Phase I/II LIBERATE trial, Quell is assessing if QEL-001 can improve liver transplant patients' immune tolerance so they no longer have to take immunosuppressive regimens.
"The nomination of this first candidate in type 1 diabetes nicely complements the advances we are making with QEL-001, our internal program in transplantation, and demonstrates the potential of our powerful technology to unlock a broad opportunity across autoimmune and inflammatory diseases," Quell CEO Iain McGill said in a statement.