On February 2, 2022 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory and other debilitating diseases, and Carna Biosciences, Inc. ("Carna") (JASDAQ: 4572), a clinical-stage biopharmaceutical company focusing on the discovery and development of innovative therapies to treat serious unmet medical needs, reported that they have entered into a licensing agreement, whereby Brickell will have the exclusive, worldwide rights to develop and commercialize Carna’s portfolio of novel, potent, and orally available Stimulator of Interferon Genes (STING) antagonists (Press release, Vical, FEB 2, 2022, View Source [SID1234607631]). STING is a well-known mediator of innate immune responses. Excessive signaling through STING is linked to a number of high unmet need diseases, ranging from autoimmune disorders, such as systemic lupus erythematosus and rheumatoid arthritis, to interferonopathies, which are a set of rare genetic conditions characterized by interferon overproduction.

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"Inhibiting the STING pathway is a compelling and differentiated approach. In many chronic inflammatory conditions, persistent inflammation results in substantial tissue damage and release of DNA fragments into the extracellular space. The cGAS-STING pathway is the crucial sensor for these extracellular DNA fragments, which triggers release of interferons and other pro-inflammatory cytokines that further exacerbates the inflammation," states Dr. Monica Luchi, Chief Medical Officer of Brickell. "STING antagonists, especially those like the lead candidate, BBI-10, that inhibit the palmitoylation site and deactivate downstream kinase signaling have continued to attract the interest of many researchers, as well as pharmaceutical companies, because of their potential to target a broad spectrum of inflammatory diseases. We are particularly excited about the potential future opportunity of STING inhibitors in a precision medicine context, considering the cGAS-STING pathway has shown to be overactive in defined clinical subgroups of autoimmune and autoinflammatory conditions, as well as severe genetic disorders."

"Our acquisition of Carna’s next-generation STING inhibitors represents a tremendous opportunity to expand our presence in immunology and inflammation and bring forward new treatment options for patients in need," commented Robert Brown, Chief Executive Officer of Brickell. "We believe that this portfolio of preclinical STING inhibitors is complementary to our current development-stage pipeline of NCEs, which includes BBI-02, a potential first-in-class DYRK1A inhibitor program that is expected to enter a Phase 1 clinical study in the coming months. These assets position us with two promising and novel immunology targets and we look forward to advancing them further throughout this year."
"These STING antagonists have been identified from our first non-kinase target project, which we expect to become another cornerstone of the company’s drug discovery research. Our compounds have demonstrated strong STING inhibitory potency in various settings, and we are thrilled that they will be further investigated by Brickell," said Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences.
"We are pleased to enter into this agreement with Brickell, as we are always looking for opportunities to accelerate the development of our drug candidates," said Kohichiro Yoshino, Ph.D., President and Chief Executive Officer at Carna Biosciences. "We admire Brickell’s expertise in developing innovative therapies, and we look forward to Brickell leading the development of our STING antagonists to potentially deliver valuable new treatment options to patients with autoimmune and inflammatory diseases."

Under the terms of the license agreement, Brickell will make a one-time cash payment to Carna of $2.0 million. In addition, Brickell will pay Carna success-based development, regulatory, and sales milestone payments of up to $258.0 million. Carna is also eligible to receive tiered royalty payments ranging from mid-single digits up to 10% of net sales. Brickell will be responsible for all future development activities and expenses related to the STING inhibitor platform.