Acazicolcept (ALPN-101)

A First-in-Class, Dual CD28/ICOS Costimulation Antagonist for Autoimmune Diseases

Acazicolcept is a first-in-class dual inhibitor of the CD28 and ICOS T cell costimulatory pathways. The molecule is being developed for treatment of severe inflammatory diseases.

CD28 and ICOS are critical costimulatory receptors that together regulate the activation, differentiation and proliferation of a range of T cells that may play a role in autoimmune and inflammatory disease. Acazicolcept was created using our directed evolution platform to engineer a single protein domain, or vIgD (Variant Ig Domain) based on a human inducible T cell costimulator ligand (ICOSL) that is capable of binding to both CD28 and ICOS. By simultaneously blocking these two key costimulatory pathways, acazicolcept has the potential to improve clinical outcomes in patients suffering from severe autoimmune and inflammatory disease.

In June 2020, we signed an exclusive worldwide option and license agreement with AbbVie for acazicolcept. Under the terms of the agreement, we received an initial payment of $60 million, with eligibility at signing to receive up to an aggregate of $805 million for exercise of the option and for successfully meeting development, regulatory, and commercial milestones. Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing, and commercialization activities for acazicolcept.

Final data for a phase 1 healthy volunteer study for acazicolcept 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
  • No Grade 3 or 4 adverse events
  • Most common adverse events were self-limited upper respiratory tract infections and headaches

In January 2021, Alpine also published phase 1 healthy volunteer study findings in the medical journal Clinical and Translational Science.

Acazicolcept: A Variant ICOSL Domain (vIgD™) Fused to an “Effectorless” IgG Fc

Acazicolcept Blocks Both CD28 and ICOS Pathways

Acazicolcept is currently enrolling Synergy, a phase 2 study of acazicolcept in patients with Systemic Lupus Erythematosus (SLE)

For more information on our ongoing clinical trials please refer to the clinical trials portion of our website. For additional information please refer to our corporate filingscorporate presentations, and scientific publications.

Join us in the discovery and development of next-generation immunotherapies.

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