CD28/ICOS dual T-cell co-stimulation inhibitor ALPN-101 for the prevention and treatment of acute transplant anti-host disease, while winning the FDA's designation of two orphan drugs

Alpine Immune Sciences announced that the U.SFood and Drug Administration (FDA) has designated two orphan drugs for the use of its ALPN-101 (Selective Dual T-Cell Costimulation Factor Inhibitor) for the prevention and treatment of acute transplant anti-host disease (GVHD)ALPN-101 is a new Fc fusion protein for the induced T-cell co-stimulation ligand (ICOSL) variant immunoglobulin domain (vIgDTM) designed to inhibit both CD28 and ICOSCD28 and ICOS are closely related co-stimulating molecules, which have partial overlapping function in T-cell activation and play an important role in a variety of autoimmune and inflammatory diseasesIn preclinical models of transplant resistance to host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 was better than drugs that blocked the CD28-CD80/86 and ICOS-ICOSL pathways alonetransplant anti-host disease (GVHD) is the most common life-threatening complication of hematopoietic cell transplantationThis occurs when donor cells treat the receptor cells as heterogeneous and attack themAcute GVHD usually occurs in the first few weeks and months after transplantation and usually involves the skin, liver and gastrointestinal tractDrMitchell HGold, Executive Chairman and CEO of Alpine, said, "We are pleased to receive the FDA's designation of orphan medicine in the field of acute GVHD, as current standard therapies are not sufficient to prevent or control the diseaseThe unique mechanism of ALPN-101 has the potential to be used as a pioneering drug for patients with aggressive and destructive autoimmune/inflammatory disease, who today have little or no treatment options"