Alpine Immune Sciences Announces Update on ALPN-303, a Dual BAFF/APRIL Inhibitor for Systemic Lupus Erythematosus and Other Autoimmune and Inflammatory Diseases, at EULAR 2022

Rhea-AI Summary

Alpine Immune Sciences (NASDAQ:ALPN) presented data on ALPN-303, a dual BAFF/APRIL antagonist, at the EULAR European Congress of Rheumatology. The compound shows high affinity binding, differentiating it from existing inhibitors. Preliminary results from a phase 1 study indicate promising pharmacodynamic reductions in circulating immunoglobulins among healthy volunteers. ALPN-303 targets severe autoimmune diseases, notably systemic lupus erythematosus. Future phase 2 studies are anticipated by the end of 2022.

Positive

• ALPN-303 demonstrates high affinity binding to BAFF and APRIL, improving over existing treatments.
• Preliminary phase 1 results show dose-dependent reductions in circulating immunoglobulins, indicating potential efficacy.
• The company plans to initiate a phase 2 study in systemic lupus erythematosus by the end of 2022.

Negative

• None.

- ALPN-303 uniquely binds BAFF and APRIL with high affinity, differentiating from related inhibitors including wild-type TACI-Fc’s -

- Ongoing phase 1 study demonstrates highly encouraging preliminary pharmacodynamic reductions in circulating immunoglobulins -

SEATTLE--(BUSINESS WIRE)-- Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, today announced the presentation of novel preclinical and clinical data in a poster titled “ALPN-303, an Engineered Dual BAFF/APRIL Antagonist, Potently Inhibits Pathogenic Autoantibodies in Preclinical Models, with Corresponding Pharmacodynamic Activity in Humans,” at the European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology. ALPN-303 is being developed for systemic lupus erythematosus and other B cell-mediated inflammatory and autoimmune diseases.

ALPN-303 is an Fc fusion of an engineered TACI domain that has significantly improved affinity against the B cell cytokines BAFF and APRIL -- particularly the latter, which wild-type TACI-Fc binds inferiorly. Correspondingly superior pharmacokinetics were observed in animals, as well as pharmacological activity in mouse models of immunization and lupus. Preliminary findings in early single dose cohorts of adult healthy volunteers demonstrate dose-dependent reductions in circulating immunoglobulins (IgA, IgG, IgM).

“The preliminary, emerging clinical findings are particularly encouraging,” said Stanford Peng, MD, PhD, Alpine’s President and Head of Research and Development, “because they are highly consistent with our nonclinical data which predict that ALPN-303 may be a more potent yet conveniently-dosed therapeutic. This is of particular importance as we endeavor to surmount challenging target diseases such as lupus and other B-cell related inflammatory diseases.”

A copy of the poster presentation is available on the Scientific Publications page of Alpine’s website.

About ALPN-303

ALPN-303 is a dual B cell cytokine antagonist being developed for multiple autoimmune and/or inflammatory diseases. Engineered by directed evolution, ALPN-303 potently inhibits the pleiotropic B cell cytokines B cell activating factor/B lymphocyte stimulator (BAFF, BLyS) and a proliferation inducing ligand (APRIL), which play key roles in B cell development, differentiation, and survival, and together contribute to the pathogenesis of multiple autoimmune diseases like systemic lupus erythematosus (SLE) and many other autoantibody-related inflammatory diseases. By simultaneously blocking these two cytokines, ALPN-303 has the potential to improve outcomes in patients suffering from severe autoimmune and/or inflammatory diseases. Initiation of a phase 2 study in systemic lupus erythematosus (SLE) and at least one basket study in renal, hematologic, and/or dermatologic indications are planned by the end of 2022.

About the Phase 1 Study

The Phase 1, randomized, placebo-controlled study in healthy adult volunteers is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously and subcutaneously administered ALPN-303, a dual BAFF/APRIL antagonist. More information on this study can be found at clinicaltrials.gov (study identifier ID NCT05034484)

About Alpine Immune Sciences

Alpine Immune Sciences is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

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 our platform technology and potential therapies; the timing of and results from clinical trials and preclinical development activities; clinical and regulatory objectives and the timing thereof; the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates; the efficacy of our clinical trial designs; and anticipated enrollment in our clinical trials and the timing thereof. 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: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery-stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and prolonged than currently anticipated; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

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Investor Relations

Alex Sharif

Director, Investor Relations and Corporate Development

Alpine Immune Sciences, Inc

206-788-4545

ir@alpineimmunesciences.com

Media Relations

Kelli Perkins

Red House

kelli@redhousecomms.com

Source: Alpine Immune Sciences Inc.

FAQ

What is ALPN-303 and its significance for Alpine Immune Sciences?

ALPN-303 is a dual BAFF/APRIL antagonist with high binding affinity, targeting autoimmune diseases like systemic lupus erythematosus, showing promising clinical data.

What were the findings from the phase 1 study of ALPN-303 presented by Alpine?

The phase 1 study indicated encouraging pharmacodynamic responses with dose-dependent reductions in immunoglobulins.

When is the next phase 2 study for ALPN-303 expected to start?

A phase 2 study for ALPN-303 is expected to begin by the end of 2022.

What was presented at the EULAR European Congress of Rheumatology regarding ALPN-303?

Alpine presented preclinical and clinical data on ALPN-303, highlighting its potential for treating autoimmune diseases.

How does ALPN-303 differ from existing BAFF/APRIL inhibitors?

ALPN-303 has been engineered for superior binding affinity compared to existing treatments, enhancing its therapeutic potential.