On August 9, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported that the United States Patent and Trademark Office has issued two patents to Aduro related to the activation of the STING (Stimulator of Interferon Genes) Pathway (Press release, Aduro Biotech, AUG 9, 2017, View Source [SID1234520129]). The first, U.S. Patent 9,724,408, jointly owned with the University of California and licensed to Aduro Biotech, covers ADU-S100 (MIW815), an investigational STING Pathway Activator being developed as a cancer therapy, and certain methods for its use. The second patent, U.S. Patent 9,695,212, claims methods of using certain additional cyclic dinucleotides (CDNs) to induce STING-dependent immune responses.
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"As leaders in cutting edge research and development of STING technologies, it is imperative that we protect our discoveries and expertise related to the modulation of the STING pathway," said Stephen T. Isaacs, chairman, president and CEO of Aduro Biotech. "These issued patents strengthen and broaden the intellectual property coverage for fundamental aspects of our clinical CDN, ADU-S100, in addition to protecting our innovative research recognizing the importance of STING as a central mediator in triggering the development of tumor-specific immunity. We have demonstrated preclinically that activating STING promotes an inflamed tumor phenotype, which led to a profound anti-cancer immune response. ADU-S100 is the first STING Pathway Activator to enter into the clinic and is in an ongoing Phase 1 dose escalation study in patients with cutaneously accessible tumors."
The issued patents bolster our patent portfolio for STING, where Aduro owns and licenses families of patents and patent applications for compounds that target the STING receptor, which would expire, or if issued would expire, between 2025 and 2038. These include both U.S. and international patent applications.
About STING Pathway Activator Platform
The Aduro-proprietary STING pathway activator product candidates, including ADU-S100, are synthetic small molecule immune modulators that are designed to target and activate human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T cell adaptive immune response.
Data from preclinical studies using multiple models demonstrated that ADU-S100 activates the STING Pathway and induced a durable local and systemic anti-tumor immune response as evidenced by induction of type I interferons (IFNs) and a CD8+ T-cell response. Additionally, preclinical data showed the combination of STING activation in the tumor microenvironment and PD-1 blockade enhanced antitumor efficacy.
ADU-S100 is currently being evaluated in a Phase 1 dose escalation study in patients with cutaneously accessible tumors. An Investigational New Drug application for the combination of ADU-S100 with an anti-PD-1 immune checkpoint antibody was recently cleared by the U.S. Food and Drug Administration, and the Phase 1b clinical study is expected to begin later in 2017.