AbbVie Nabs Exclusive Worldwide Option for Alpine’s CD28/ICOS Dual Inhibitor
By Ruchi Jhonsa, Ph.D.
On June 18th, Seattle-based Alpine Immune Sciences announced that it has made a global option and license deal with AbbVie for the development and commercialization of its midstage lupus and autoimmune drug, ALPN-101.
ALPN-101 is a first-in-class dual inhibitor of CD28/ICOS co-stimulation molecules that play critical roles in multiple autoimmune and inflammatory diseases. The drug has shown potent immunosuppressive activities in multiple preclinical disease models including systemic lupus erythematosus with favorable safety and tolerability, pharmacokinetics, and pharmacodynamics in the first-in-human study in adult healthy volunteers. The duo is planning to test the drug in various other inflammatory indications including, graft vs. host disease, inflammatory arthritis, connective tissue disease, multiple sclerosis, and lupus.
Systemic Lupus Erythematosus (SLE)
SLE is an autoimmune disease that causes inflammation-induced tissue damage to joints, skin, brain, lungs, and kidneys. GSK’s Benlysta is the only FDA approved medication, which at the time of approval was the first new lupus treatment in 50 years. However, the drug showed only modest response along with serious side effects leading to a plunge in drug sales. Filling the gap, now, there are many players in the field including AstraZeneca, Biogen, and Celgene/BMS who are developing drugs for SLE.
Under the terms of the deal, AbbVie will make an upfront payment of $60 million to Alpine for an option to license the drug. In the option period, Alpine will run the Phase 2 study in patients with lupus. If the drug succeeds and progresses beyond Phase 2, Alpine would be eligible to receive up to $805 million in conditional payments for exercise of the option. Abbvie will then be responsible for conducting future clinical development, manufacturing, and commercialization.
“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,” said Mitchell H. Gold, M.D., Executive Chairman, and CEO of Alpine Immune Sciences.
CD28 and Inducible T-cell co-stimulator (ICOS) are the molecules expressed on T cells that play critical roles in T cell activation and adaptive immunity by interacting with CD80/CD86 and ICOS ligand respectively. ALPN-101 is a novel Fc fusion protein of human ICOS ligand variant immunoglobulin domain that can block both CD28 and ICOS receptors. In preclinical models of graft vs. host disease, inflammatory arthritis, connective tissue disease, multiple sclerosis, and lupus, the drug shows superiority in comparison to other drug candidates that block CD28-CD80/86 and/or ICOS-ICOL pathways. The drug is currently being tested in the Phase 1 trial on patients with acute GVHD.
Updates from the Phase 1 Study
The company presented updates from the first-in-human Phase 1 study of ALPN-101 on healthy volunteers at the European League against Rheumatism E-Congress on June 6th. A total of 96 healthy adults participated in the study that evaluated the safety of the drug doses ranging from 1ug/kg to 10mg/kg. The data presented showed that the drug was well tolerated at all dose levels with no severe adverse events or clinically significant immunogenicity events or events of cytokine release were seen.
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, MD, Ph.D., Alpine’s President, and Head of R&D. “They demonstrate safety, tolerability, and pharmacological activity of multi dose regimens, enabling the design of Phase 2 studies. We look forward to the opportunity to explore ALPN-101 in multiple inflammatory diseases in the future.”
Editor: Rajaneesh K. Gopinath, Ph.D.
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