Alpine Immune Sciences Provides Clinical Update of its Phase 1 Trial of ALPN-101 in Healthy Volunteers at the European League Against Rheumatism (EULAR) E-Congress 2020

June 8, 2020

-- ALPN-101 was well tolerated and exhibited potent pharmacodynamic activity, enabling Phase 2 development --

SEATTLE--(BUSINESS WIRE)--Jun. 8, 2020-- Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented updated results from its Phase 1 Healthy Volunteer Study of ALPN-101, the company’s first-in-class dual CD28/ICOS costimulation antagonist for the treatment of autoimmune and inflammatory diseases.

The poster, entitled “A Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, in Healthy Volunteers (HV)”, was presented during the SLE, Sjögren’s, and APS – Treatment poster session of the European League Against Rheumatism (EULAR) E-Congress on Saturday, June 6, 2020.

This first-in-human study (NCT03748836) randomized 96 healthy adults to receive single or multiple, intravenous or subcutaneous, placebo or ALPN-101 at doses ranging from 1 μg/kg to 10 mg/kg. At all dose levels, ALPN-101 was well tolerated with no severe adverse events, clinically-significant immunogenicity events, or evidence of cytokine release. Pharmacokinetics and pharmacodynamics exhibited desirable dose dependence, with increasing doses corresponding to increasing duration of complete or near-complete target saturation, as well as inhibition of antibody responses to keyhole limpet hemocyanin (KLH) immunization.

“These findings extend upon the previously disclosed single ascending dose data and continue to encourage us regarding ALPN-101’s future potential,” said Stanford Peng, MD PhD, Alpine’s President and Head of Research and Development. “They demonstrate the safety, tolerability, and pharmacological activity of multi-dose regimens, enabling the design of Phase 2 studies. We look forward to the opportunity to explore ALPN-101 in multiple inflammatory diseases in the future.”

A copy of the poster is available in the “Scientific Publications” section of Alpine’s website at www.alpineimmunesciences.com.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 - CD80/86 and/or ICOS - ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) has been initiated.

About Alpine Immune Sciences, Inc.

Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients’ lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed enrollment of a phase 1 healthy volunteer study, and BALANCE, a phase 1b/2 study in acute GVHD, has recently been initiated. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

Paul Rickey
Chief Financial Officer
Alpine Immune Sciences, Inc.
206-788-4545
[email protected]

Laurence Watts
Managing Director
Gilmartin Group, LLC.
619-916-7620
[email protected]

Source: Alpine Immune Sciences Inc.