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FDA grants ALPN-101 an Orphan Drug Designation for the prevention and treatment of acute GvHD

Apr 6, 2020

On March 18, 2020, the U.S. Food and Drug Administration (FDA) granted an Orphan Drug Designation for ALPN-101 for the prevention and treatment of acute graft-versus-host disease (aGvHD).1

ALPN-101 is a first-in-class Fc fusion protein of a human inducible T-cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™). The drug targets inflammatory process by simultaneous inhibition of the CD28 and ICOS signaling pathways, which are involved in T-cell activation. Results in preclinical models of GvHD, and other autoimmune and inflammatory diseases, such as inflammatory arthritis, and multiple sclerosis, revealed improved efficacy of dual CD28-ICOS blockade with ALPN-101 vs single pathway blockade.2

A phase I study (NCT03748836) of ALPN-101 in healthy volunteers completed enrolment in October 2019. The initial data were presented at the American Society of Hematology annual meeting in December 2019, with more data expected in 2020. A phase I/IIb Balance study (NCT04227938) investigating ALPN-101 in patients with steroid-refractory/resistant aGvHD is currently recruiting.

  1. Alpine Immune Sciences. Alpine Immune Sciences’ ALPN-101 Receives FDA Orphan Drug Designations for the Prevention and Treatment of Acute Graft Versus Host Disease. Published March 18, 2020. Accessed April 6, 2020

  2. Dillon S, Lewis K, Evans L. et al. Alpn-101, a Dual ICOS/CD28 Antagonist, Demonstrates Potent and Dose-Dependent Suppression of Graft Vs. Host Disease (GvHD) in a Human/NSG Mouse Xenograft Model, with Activity Superior to CD28 or ICOS Single Pathway Antagonists. Biol Blood Marrow Tr. 2019; 25(3):S290– DOI:10.1016/j.bbmt.2018.12.666


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