Alpine Immune Sciences to Present ALPN-303 Phase 1 (RUBY-1) Study Data at 2022 American Society of Hematology Annual Meeting & Exposition

Rhea-AI Summary

Alpine Immune Sciences (NASDAQ: ALPN) announced a poster presentation at the American Society of Hematology meeting happening from December 10-13, 2022. The presentation will discuss the phase 1 study (RUBY-1) of ALPN-303, a dual BAFF/APRIL antagonist for treating autoimmune cytopenias. The study aims to assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers, with initial data supporting a dosing regimen of once every four weeks. The poster will be displayed on December 12, 2022, at 6:00 PM EST.

Positive

• Initial data from the RUBY-1 study indicate ALPN-303 is well tolerated at doses up to 960 mg.
• The drug exhibited dose-dependent pharmacokinetics and reduced immunoglobulin levels, suggesting a feasible dosing regimen for future studies.

Negative

• None.

SEATTLE--(BUSINESS WIRE)-- Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases will have a poster presentation for ALPN-303’s phase 1 study (RUBY-1) at the upcoming American Society of Hematology (ASH) Annual Meeting & Exposition, December 10-13, 2022.

Date/Time: December 12, 2022, at 6:00pm - 8:00pm EST
Poster Title: A Randomized, Placebo-Controlled, Phase 1 Study of Healthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Potent Dual BAFF/APRIL Antagonist for the Treatment of Autoimmune Cytopenias
Poster Number: 3763
Session Name: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster III
Location: Ernest N. Morial Convention Center, Hall D

About ALPN-303 and the RUBY-1 Phase 1 Study

ALPN-303 is a dual antagonist of the BAFF (B cell activating factor) and APRIL (proliferation inducing ligand) cytokines, which play key roles in the survival and activation of B cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, ALPN-303 exhibits greater potency in preclinical studies versus comparators based on wild-type TACI, as well as other inhibitors of BAFF and/or APRIL alone. ALPN-303 is in development for multiple B cell and/or autoantibody-related diseases, such as systemic lupus erythematosus, glomerulonephritides, and autoimmune cytopenias.

RUBY-1 (NCT05034484) is a phase 1, randomized, placebo-controlled study in healthy adult volunteers designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of intravenously and subcutaneously administered ALPN-303. Initial data show ALPN-303 to be well tolerated up to 960 mg with dose-dependent pharmacokinetics and reductions in circulating immunoglobulins and antibody-secreting cells, supporting the use of a once every four-week dose regimen for subsequent studies.

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 potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates; and the timing of our public presentations and potential publication of future clinical data. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005542/en/

Temre Johnson (Investors)

Alpine Immune Sciences, Inc.

ir@alpineimmunesciences.com

Kelli Perkins (Media)

Red House

kelli@redhousecomms.com

Source: Alpine Immune Sciences, Inc.

FAQ

What is the purpose of the RUBY-1 study for ALPN-303?

The RUBY-1 study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALPN-303 in healthy adult volunteers.

When will Alpine Immune Sciences present the RUBY-1 study results?

The results will be presented at the American Society of Hematology meeting on December 12, 2022.

What are the initial findings of the ALPN-303 trial?

Initial findings indicate that ALPN-303 is well tolerated, showing dose-dependent pharmacokinetics and reductions in circulating immunoglobulins.

What potential diseases is ALPN-303 targeted to treat?

ALPN-303 is being developed for autoimmune-related diseases, including systemic lupus erythematosus and autoimmune cytopenias.

What is the significance of ALPN-303's dual antagonist properties?

ALPN-303's dual antagonist activity against BAFF and APRIL may lead to improved efficacy in treating B cell-related diseases compared to single-target therapies.