AbbVie and Cugene announced an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases.

Selective IL-2 muteins have the potential to represent a major advancement in the standard of care for patients with autoimmune and inflammatory diseases. Cugene's lead candidate, CUG252, is an engineered IL-2 mutein designed to selectively activate and expand immune-suppressive Treg cells while reducing undesired IL-2 activity on other IL-2 receptor expressing cells for the treatment of autoimmune diseases. CUG252 is currently in a Phase 1 study in healthy volunteers.

"AbbVie is committed to developing novel therapies in immunology where unmet needs remain for patients living with complex autoimmune and inflammatory conditions," said Tom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. "Our partnership with Cugene is the latest in our efforts to develop and advance potential next-generation therapies like CUG252."

"We are very pleased to partner with AbbVie, a global leader in the development and commercialization of innovative immunology therapies," said Luke Li, M.D., Chief Executive Officer of Cugene Inc. "AbbVie is an ideal partner for CUG252, with their commitment to R&D, deep therapeutic area expertise, and the global resources needed to maximize CUG252's therapeutic potential for patients suffering from autoimmune diseases. Today's agreement highlights Cugene's unique precision engineering platform that has yielded multiple product candidates, including CUG252. We look forward to collaborating with AbbVie to transform clinical outcomes in autoimmune disease."

Under the terms of the agreement, Cugene will receive an upfront payment of US $ 48.5 million, and will also be eligible to receive development and regulatory milestones and a license option exercise payment if AbbVie exercises the option. In addition, Cugene may also receive commercialization and sales-based milestones and tiered royalties. AbbVie will receive an option to obtain an exclusive license for certain IL-2 muteins, including CUG252. During the option period, Cugene will conduct a Phase 1b study in patients with autoimmune/inflammatory disease.  Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing and commercialization activities for CUG252.