SOURCE: Kadmon Corporation, LLC

Kadmon Corporation, LLC

March 27, 2014 09:00 ET

Kadmon Corporation Presents Results at the 9th International Congress on Autoimmunity Demonstrating the Effects of KD025 on Immune Homeostasis

Preclinical, Clinical Results Support Broad Development Strategy

NEW YORK, NY--(Marketwired - Mar 27, 2014) - Kadmon Corporation, LLC, today announced the presentation of data demonstrating the effects of KD025, the Company's Phase 2, orally bioavailable, potent and highly selective inhibitor of ROCK 2 (Rho-associated coiled-coiled kinase 2), on immune homeostasis. The data were presented at the "T Cells and Autoimmunity" session by Alexandra Zanin-Zhorov, Ph.D., Kadmon's Senior Director of Immunology, at the 9th Annual International Congress on Autoimmunity held March 26 - 30 in Nice, France.

The immune system's T lymphocytes play a critical role in autoimmunity, particularly the pro-inflammatory T-helper 17 (Th17) cells and pro-resolution regulatory T (Treg) cells. Whereas Treg cells have an essential role in suppressing immune responses, Th17 cells, through secretion of pro-inflammatory cytokines such as IL-17, IL-21 and IL-22, are actively involved in the pathogenesis of the majority of autoimmune disorders. KD025 has been shown to down regulate auto-aggressive immune responses by targeting pro-inflammatory Th17 cells through the down regulation of STAT3 phosphorylation and IRF4 and RORγt expression, and promoting the suppressive function of Treg cells through up-regulation of STAT5 phosphorylation and Foxp3 expression. This activity is achieved with a minimal effect on the rest of the immune response, supporting a clean safety profile for the drug. 

Kadmon illustrated the potential of this mechanism through results presented today from in vitro studies, various mouse models, and ex vivo analyses of samples from its Phase 1 clinical trial. Among the findings were data demonstrating that KD025 inhibits IL-17, IL-21 and IFN-γ secretion, and reduces the number of IL-17 and IFN-γ-producing CD4+ T cells from rheumatoid arthritis patients, ex vivo, results supported by data showing KD025 inhibits the progression of collagen-induced arthritis in mice. Overall, studies with KD025 to date have demonstrated strong consistency across experimental models, and underscore KD025's potent ability to down-regulate autoimmunity.

"As a very well tolerated, potent, orally bioavailable inhibitor of ROCK2, KD025 holds tremendous potential in autoimmune disorders, in that it can restore balance to the immune system without suppressing its function," said Samuel D. Waksal, Ph.D., Chairman and CEO of Kadmon. "KD025's activity is highly consistent across disease models, and has translated well to the clinic. We look forward to initiating several Phase 2 studies of KD025 in the near future in autoimmune disorders including psoriasis, lupus nephritis and non-alcoholic steatohepatitis."

About Kadmon Corporation

Kadmon Corporation, LLC, is a global company built on a 21st-century paradigm for the translation of innovative science into treatment. The company currently offers products and services for the treatment and management of liver diseases, and is pioneering novel medicines in areas of serious disease, including oncology, immunology and infectious, neurodegenerative and ophthalmic diseases. Emphasizing emerging concepts in molecular biology and genomics, Kadmon is developing treatments and treatment combinations that target the metabolomics and signaling pathways associated with disease, with the goal of addressing some of today's most pressing areas of unmet medical need. For more information, visit

This press release contains forward-looking statements. These forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of original issue. Kadmon expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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