AbbVie and Alpine Immune Ink $865 Million Deal to License Drug for Lupus and Other Inflammatory Diseases

Alpine Immune Sciences shares exploded 211% in premarket trading at news of a global option and license deal with AbbVie.

Under the terms of the deal, AbbVie is paying Alpine an upfront payment of $60 million for rights to ALPN-101, a first-in-class dual CD28/ICOS costimulation antagonist. CD28 and ICOS are costimulatory molecules that have critical roles in several autoimmune and inflammatory diseases. The drug inhibits both CD28 and ICOS pathways in multiple preclinical disease models, including systemic lupus erythematosus (SLE).

In addition to the $60 million upfront payment, Alpine is eligible for up to $805 million in option and success-based development, regulatory and commercial milestones, so-called “biobucks.” Alpine is also eligible for tiered royalties on net sales of ALPN-101. AbbVie picks up an option for an exclusive license for the compound. During the option period, Alpine will run a Phase II trial in lupus. Once AbbVie exercises its option, AbbVie will conduct future clinical development, manufacturing and commercialization.

“We are very pleased to partner ALPN-101 with AbbVie, a world leader in the development and commercialization of innovative immunology therapies,” said Mitchell H. Gold, executive chairman and chief executive officer of Alpine. “AbbVie is an ideal partner for ALPN-101, with the therapeutic area expertise, R&D commitment, and global resources needed to maximize ALPN-101’s potential for patients suffering from autoimmune diseases. Today’s agreement validates our unique Directed Evolution platform that has yielded multiple product candidates, including ALPN-101. We look forward to working with our colleagues at AbbVie to potentially transform clinical outcomes in systemic lupus erythematosus, a disease with currently few appealing treatment options.”

On June 15, the company presented a poster at the AACR Virtual Annual Meeting on its ALPN-202, a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor and its ability to overcome T-cell suppression by M2c macrophages and improve the durability of engineered T-cell anti-tumor responses. That drug is currently in a Phase I trial in advanced cancers.

A week before, on June 8, the company updated data from its Phase I Healthy Volunteer Study of ALPN-101 in a poster at the European League Against Rheumatism (EULAR) E-Congress. The trial randomized 96 healthy adults to receive one or multiple intravenous or subcutaneous doses of either ALPN-101 or a placebo at doses ranging from 1 microgram/kilogram to 10 mg/kg. At all doses levels, the drug showed no severe side effects, no clinically significant immunogenicity or cytokine release. The drugs showed desirable dose dependence.

“These findings extend upon the previously disclosed single ascending dose data and continue to encourage us regarding ALPN-101’s future potential,” said Stanford Peng, Alpine’s president and head of research and development. “They demonstrate the safety, tolerability, and pharmacological activity of multi-dose regimens, enabling the design of Phase II studies. We look forward to the opportunity to explore ALPN-101 in multiple inflammatory diseases in the future.”

The companies are considering ALPN-101 in graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, as well as lupus.

In 2011, the U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline’s Benlysta for SLE, which at the time was the first new lupus treatment in 50 years.

Since then, other companies have made headway against the disease, including AstraZeneca, Biogen, and Celgene/Bristol Myers Squibb.

According to the U.S. Centers for Disease Control and Prevention, SLE is the most common form of lupus. SLE is an autoimmune disease causing broad inflammation and tissue damage to the joints, skin, brain, lungs, kidneys, and blood vessels. It can range from mild to life-threatening.