A first-in-class dual CD28/ICOS antagonist
ALPN-101 is a first-in-class dual inhibitor of the CD28 and ICOS T cell costimulatory pathways being developed for treatment of severe inflammatory diseases. Leveraging our proprietary scientific platform, our scientists engineered a single protein domain, or vIgD (Variant Ig Domain) based on human inducible T cell costimulator ligand (ICOSL) that is capable of binding to both CD28 and ICOS. By simultaneously blocking two key costimulatory pathways, ALPN-101 has the potential to improve outcomes in patients suffering from severe autoimmune/inflammatory disease.
In June 2020, we signed an exclusive worldwide option and license agreement with AbbVie for ALPN-101. During the option period, we will conduct a phase 2 study in systemic lupus erythematosus. 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, we will receive an upfront payment of $60 million, and will also be eligible to receive up to an aggregate of $805 million for exercise of the option and success-based development, regulatory and commercial milestones.
ALPN-101 completed enrollment of a Phase 1 healthy volunteer study in October 2019. Final data were presented at the 2020 EULAR E-Congress. The key findings presented are summarized below:
- No infusion-related, hypersensitivity, or allergic reactions
- No cytokine storm or release (CytokineMAP A&B)
- No grade 3+ adverse events
- Most common adverse events were self-limited upper respiratory tract infections and headaches
ALPN-101: A First-in-Class Dual CD28/ICOS Antagonist
for Multiple Inflammatory Disease Indications
The unique differentiation and therapeutic potential of ALPN-101 across multiple indications is supported by robust and comprehensive preclinical studies presented at scientific meetings and conferences over the last several years. This research includes data demonstrating ALPN-101:
- Improves survival compared to belatacept in an in vivo animal GVHD model
- In a model of arthritis, reduces disease severity and delays disease onset time relative to control, with activity superior to abatacept, an FDA-approved drug for rheumatoid, psoriatic, and juvenile idiopathic arthritis
- Controls colitis in an in vivo model of inflammatory bowel disease, or IBD
- Improves multiple sclerosis disease scores in an in vivo model of multiple sclerosis, or MS, compared to abatacept
- Lowers the incidence and severity of sialadenitis, an in vivo model of Sjögren’s syndrome, as compared to abatacept or wild-type ICOSL-Fc alone or in combination.
Details of our published research can be found here.