Graft Versus Host Disease (GVHD)

Alpine Immune Sciences’ ALPN-101 Receives FDA Orphan Drug Designations for the Prevention and Treatment of Acute Graft Versus Host Disease

Retrieved on: 
Wednesday, March 18, 2020
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Health, Articles, Food and Drug Administration, Pharmaceuticals policy, Drug discovery, Transplantation medicine, Graft-versus-host disease, Orphan drug, Orphan Drug Act, Clinical trial, Graft Versus Host Disease (GVHD), ALPN-101, Alpine Immune Sciences, Inc.

Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the U.S. following marketing approval by the FDA.

Key Points: 
  • Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the U.S. following marketing approval by the FDA.
  • The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.
  • To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at ir.alpineimmunesciences.com.
  • Graft versus host disease (GVHD) is the most common life-threatening complication of a hematopoietic cell transplant.

Alpine Immune Sciences Presents ALPN-101 Phase 1 Healthy Volunteer Study Data and Details of Upcoming Phase I/II BALANCE GVHD Study at the 61st American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 9, 2019
Biotechnology, Pharmaceutical, Health, Oncology, Medical specialties, Medicine, Immunology, Transplantation medicine, Immune system, CD278, Graft-versus-host disease, CD28, CD80, Icos, Co-stimulation, T cell, Graft Versus Host Disease (GVHD), ALPN-101, Alpine Immune Sciences, Inc.

T cell costimulation via the CD28 and ICOS pathways is critical to the pathogenesis of GVHD.

Key Points: 
  • T cell costimulation via the CD28 and ICOS pathways is critical to the pathogenesis of GVHD.
  • It exhibits a potent, unique activity superior to combinations of biologics individually antagonizing the CD28 CD80/86 and ICOS ICOSL pathways.
  • BALANCE is a Phase 1/2, first-in-disease dose escalation and expansion study of ALPN-101 in patients with active, steroid-refractory or steroid-resistant acute GVHD.
  • CD28 and ICOS appear to be key pathways in the pathogenesis of GVHD, and the presented data with ALPN-101 appear uniquely strong.