AbbVie Secures Global Rights to Alpine's Lupus Drug Candidate ALPN-101 in $865 Million Deal

Compiled by S. Li

On June 18, Alpine Immune Sciences, Inc. (“Alpine”), a biotechnology company focused on developing innovative therapies for cancer and autoimmune inflammatory diseases, announced that it had reached a global licensing agreement with AbbVie for the investigational therapy ALPN-101. Following the announcement, Alpine’s stock price surged 211% in pre-market trading.

Under the terms of the agreement, Alpine will receive a $60 million upfront payment and will be eligible for total potential payments of up to $805 million based on option exercises, research and development, regulatory, and commercial milestones. In addition, Alpine will receive tiered royalties on net sales of ALPN-101.

Through this transaction, AbbVie will obtain the global exclusive option to license ALPN-101. During the option period, Alpine will conduct a Phase 2 clinical study for systemic lupus erythematosus (SLE), after which AbbVie will be responsible for the future clinical development, manufacturing, and commercialization of ALPN-101.

ALPN-101 is a first-in-class dual CD28/ICOS costimulatory agonist currently in Phase 2 clinical development. CD28 and ICOS are costimulatory molecules that play key roles in various autoimmune and inflammatory diseases. ALPN-101 is an effective inhibitor of the CD28/ICOS pathway, demonstrating superior efficacy compared to single-pathway blockade in multiple preclinical disease models. Furthermore, it has exhibited favorable safety, tolerability, pharmacokinetic, and pharmacodynamic profiles in adult healthy volunteers.

On the 8th of this month, Alpine updated the Phase 1 clinical trial data of ALPN-101 in healthy volunteers at the European Alliance of Associations for Rheumatology (EULAR) conference. The trial enrolled 96 healthy adults who were randomized to receive ALPN-101 at doses ranging from 1 mg/kg to 10 mg/kg or placebo, administered via intravenous or subcutaneous injection. The results showed that the drug did not exhibit serious side effects at all dose levels, with no significant immunogenicity or cytokine release observed clinically, and demonstrated desirable dose-dependent characteristics.

Dr. Mitchell H. Gold, Chief Executive Officer and Executive Chairman of Alpine, stated, “We are delighted to collaborate with AbbVie on the development of ALPN-101. AbbVie is an ideal partner for ALPN-101, bringing therapeutic area expertise, R&D capabilities, and the global resources necessary to maximize the potential of ALPN-101 in patients with autoimmune diseases.”

Dr. Tom Hudson, Senior Vice President and Chief Executive Officer of AbbVie, stated, “As a next-generation therapy for systemic lupus erythematosus and other autoimmune diseases, ALPN-101’s dual mechanism of action holds significant potential.”

References:

1、Alpine Immune Sciences and AbbVie Announce Option and License Agreement for the Development and Commercialization of ALPN-101

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