- ALPN-303 demonstrates superior immunomodulatory activity and efficacy in preclinical models -
- Phase 1 study to begin Q4 2021 -
Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company, today announced a presentation in a Plenary session of the American College of Rheumatology (ACR) Convergence 2021 Annual Meeting. The oral presentation will highlight the preclinical development of ALPN-303, an engineered dual BAFF/APRIL inhibitor being developed for B cell-related diseases such as systemic lupus erythematosus.
The presentation will highlight preclinical data that suggest a best-in-class profile compared to wild-type TACI-Fc:
- ALPN-303 inhibits the activity of the B cell cytokines APRIL and BAFF with greater than 5-fold greater potency in vitro;
- In mice, ALPN-303 exhibits superior pharmacodynamics, including greater suppression of T-dependent antibody production and reduction of B cell populations, such as follicular B cells;
- In cynomolgus monkeys, ALPN-303 is well tolerated and exhibits nearly 3-fold greater serum exposure, accompanied by a greater than 2.5X maximal percent reduction from baseline in serum immunoglobulins (IgG, IgM, IgA); and
- In a mouse model of lupus, ALPN-303 treatment significantly suppresses anti-double stranded DNA antibody titers, inflammation in the kidneys (glomerulonephritis), while preserving renal function and improving survival.
“These findings reinforce the data we presented earlier this year at EULAR, and continue to suggest that ALPN-303 may prove to be a superior therapy for many severe diseases like lupus,” noted Stanford Peng, M.D., Ph.D., President and Head of R&D at Alpine. “We look forward to initiating enrollment in its first-in-human study in adult healthy volunteers later this quarter, and thereby enable rapid advancement of this novel, potentially best-in-class therapy in multiple indications.”
The abstract titled “ALPN-303, an Enhanced, Potent Dual BAFF/APRIL Antagonist Engineered by Directed Evolution for the Treatment of Systemic Lupus Erythematosus (SLE) and Other B Cell-Related Diseases”, can be found here. A copy of the presentation will be available on the “Scientific Publications” page of the Alpine Website.
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 (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.
About the Phase 1 Study
The Phase 1, randomized, placebo-controlled study in healthy adult participants 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.
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