AbbVie is spending $60 million upfront for a midstage lupus and autoimmune asset currently developed by Alpine Immune Sciences.
The deal is centered on ALPN-101, a phase 2-ready, first-in-class dual CD28/ICOS costimulation antagonist, which will be tested in systemic lupus erythematosus (SLE) as well as in other autoimmune areas.
Under the pact, AbbVie grabs the rights to the experimental therapy and could pay up to $805 million in biobucks, as well as royalties, should the med gain approval.
During the option period, Alpine will run a phase 2 test in LSE, after which, should AbbVie take the option, it will run all future clinical development, manufacturing and sales activities for ALPN-101.
A few years back, SLE was a tough nut to crack, with GlaxoSmithKline’s Benlysta the only newly approved med for the condition, but one with low sales. In recent years, a string of R&D failures has given way to more positive notes, with AstraZeneca, Biogen and Celgene/Bristol Myers Squibb all seeing more upbeat trends for their efforts.
Alpine’s drug targets CD28 and ICOS, which it says are key costimulatory molecules that likely play critical roles in multiple autoimmune and inflammatory diseases.
It’s currently only been in preclinical and early clinical tests; the bigger phase 2 will start to show whether this drug can prove good efficacy.
“We are very pleased to partner ALPN-101 with AbbVie, a world leader in the development and commercialization of innovative immunology therapies,” said Mitchell Gold, M.D., executive chairman and CEO 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.”
SLE, which affects far more women than men, causes systemic inflammation which affects multiple organs.
In addition to affecting the skin and joints, it can affect other organs in the body such as the kidneys and the tissue lining the lungs, heart and brain. Many patients experience fatigue, weight loss and fever.
“AbbVie’s expertise in Immunology has led to remarkable breakthroughs in the treatment of autoimmune diseases,” added Tom Hudson, M.D., senior vice president and chief scientific officer at AbbVie. “ALPN-101’s dual mechanism of action has compelling potential as a next-generation treatment in systemic lupus erythematosus and other autoimmune diseases. We are excited to partner with the team at Alpine on the development of this novel therapeutic.”
Shares in Alpine were up a massive 230% premarket on the news.