SEATTLE, WA, USA I June 24, 2021 I Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, announced today that the first patient has been dosed in Synergy, a Phase 2 study of ALPN-101 in patients with Systemic Lupus Erythematosus (SLE). Alpine also announced the achievement of $45 million in pre-option exercise development milestones as part of the 2020 Option and License Agreement with AbbVie.

“The initiation of Synergy is an important milestone as we work to advance therapies for patients suffering from autoimmune and inflammatory disease,” said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. “We look forward to continuing our partnership with AbbVie to develop ALPN-101, a potentially transformative therapy for patients with systemic lupus erythematosus and other autoimmune diseases”.

About Synergy

Synergy (NCT04835441) is a global, randomized, double-blind, placebo-controlled Phase 2 clinical trial of ALPN-101 in moderate-to-severe systemic lupus erythematosus (SLE) patients. It initiated enrollment in June 2021.

About ALPN-101

ALPN-101 is a first-in-class, dual inhibitor of the CD28 and ICOS T-cell costimulatory pathways being developed for treatment of systemic lupus erythematosus (SLE). By simultaneously blocking two key costimulatory pathways, ALPN-101 has the potential to improve outcomes in patients suffering from severe autoimmune/inflammatory diseases. Preclinical studies have demonstrated efficacy in models of SLE, Sjögren’s syndrome, arthritis, inflammatory bowel disease, multiple sclerosis, type 1 diabetes, uveitis, and graft versus host disease. In a Phase 1 study in healthy adult volunteers, ALPN-101 was well-tolerated, and exhibited dose-dependent pharmacokinetics and pharmacodynamics.

AbbVie 2020 License and Option Agreement

In June 2020, Alpine entered into an exclusive worldwide option and license agreement with AbbVie for ALPN-101. Prior to the exercise of the license option, Alpine will conduct ALPN-101 development efforts, including a Phase 2 study in systemic lupus erythematosus (SLE). Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing, and commercialization activities for ALPN-101. Under the terms of the agreement, Alpine received an upfront payment of $60 million, has achieved $45 million of the $75 million pre-option exercise development milestones, and will also be eligible to receive up to an aggregate of $730 million for exercise of the option and success-based development, regulatory and commercial milestones.

About Alpine Immune Sciences, Inc.

Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit Follow @AlpineImmuneSci on Twitter and LinkedIn.

SOURCE: Alpine Immune Sciences