Alpine Immune Sciences’ Lead Program ALPN-101 Demonstrates Preclinical Activity in Inflammatory Arthritis and Neurological Inflammation

October 22, 2018

Data from experimental models of inflammatory arthritis and multiple sclerosis presented at 2018 ACR/ARHP Annual Meeting and 143rd Annual Meeting of the American Neurological Association

ALPN-101 has completed CMC scale up and is poised to be the first dual ICOS/CD28 antagonist in clinic in Q1 2019

SEATTLE--(BUSINESS WIRE)--Oct. 22, 2018-- Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company, presented positive results from preclinical studies of its lead program ALPN-101, a dual ICOS/CD28 antagonist, in experimental models of inflammatory arthritis and multiple sclerosis. The data were presented on Sunday, October 21, 2018 in poster sessions during the 2018 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago and the 143rd Annual Meeting of the American Neurological Association (ANA) in Atlanta.

“We continue to be encouraged by the emerging activity of ALPN-101 in multiple inflammatory disease models. In particular, its superiority over abatacept (CTLA4-Ig), an approved CD28 pathway inhibitor, strongly supports its dual target rationale,” said Stanford Peng, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Alpine. “ALPN-101 may therefore be effective in multiple autoimmune and/or inflammatory diseases. We are rapidly advancing ALPN-101 toward clinical trials and expect to initiate a Phase 1 study in the first quarter of 2019.”

ALPN-101, a Dual ICOS/CD28 Antagonist, Potently Suppresses Disease in Multiple Mouse Models of Autoimmunity (Poster #71873)
The preclinical studies presented at the ACR/ARHP Annual Meeting evaluated the activity of ALPN-101 in a collagen-induced arthritis (CIA) and an experimental autoimmune encephalomyelitis (EAE) model. Abatacept was used as a key comparator.

Results showed:

  • ALPN-101, given preventively or therapeutically, significantly reduced disease activity in CIA.
  • ALPN-101 was more efficacious than interventions on the CD28 or ICOS pathways alone.
  • In CIA, ALPN-101 inhibited multiple biomarkers associated with disease, including inflammatory cytokines, anti-collagen autoantibodies, and activated T cells.

Therapeutic Candidate ALPN-101, a Dual ICOS/CD28 Antagonist, Demonstrates In Vivo Efficacy in an Experimental Autoimmune Encephalomyelitis (EAE) Model (Poster #S254)
The preclinical study presented at the ANA Annual Meeting evaluated the activity of ALPN-101 in mouse EAE, a model for multiple sclerosis. Abatacept was also used as a comparator.

Results showed:

  • ALPN-101 was superior to abatacept in reducing EAE as assessed by body weight and clinical scores.
  • ALPN-101 reduced pro-inflammatory cytokines and activated T cells in vitro and in vivo.

Both posters are available on the company’s website at https://www.alpineimmunesciences.com/pipeline/autoimmune-inflammation/

About Alpine Immune Sciences, Inc.
Alpine Immune Sciences, Inc. is committed to leading a new wave of functional immune therapeutics. Alpine is the first company employing directed evolution to create potentially powerful multifunctional immunotherapies to improve patients’ lives. Supported by promising preclinical data, we aim to have two programs in the clinic in 2019. The first, ALPN-101 for autoimmune/inflammatory diseases, is a dual ICOS/CD28 antagonist, engineered to reduce pathogenic immune responses. The second, ALPN-202 for cancer, is a dual PD-L1/CTLA-4 antagonist and PD-L1-dependent CD28 T cell costimulator intended to combine checkpoint inhibition with a necessary costimulation signal – an approach currently absent from approved checkpoint therapies. Alpine is backed by world-class research capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact, and include statements regarding Alpine’s platform technology and potential therapies. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: Alpine’s discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products on a timely or cost-effective basis or at all; Alpine may not achieve additional milestone payments pursuant to its collaborations; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in Alpine’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Alpine undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

“Transmembrane Immunomodulatory Protein,” “TIP,” “Variant Ig Domain,” “vIgD” and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

Source: Alpine Immune Sciences, Inc.

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