AbbVie and Cugene Announce Collaboration in Autoimmune Diseases

- AbbVie receives the option to license worldwide rights to CUG252 from Cugene, a clinical-stage and potential best-in-class Treg-selective IL-2 mutein, building on AbbVie's commitment to developing novel therapies in immunology

- Cugene to complete a Phase 1a study in healthy volunteers and to conduct a Phase 1b study in patients with autoimmune/inflammatory disease during the option period

NORTH CHICAGO, Ill. and WALTHAM, Mass., May 16, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Cugene Inc., a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer, today 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 $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.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn

About Cugene Inc.

Cugene is a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer. Cugene is advancing an armamentarium of precision immune therapeutics with compelling target biology to improve patients' lives by utilizing unique precision engineering technologies, including cytokine-based TILKine™ and VitoKine multiproduct platforms. Cugene is backed by world-class scientific and clinical advisors, a proven management team, and a global healthcare focused investment fund. For more information, visit us at www.cugene.com and follow Cugene on LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.