ImmuneSensor Therapeutics Secures U.S. Patent for Oral cGAS Inhibitors

ImmuneSensor Therapeutics, a clinical-stage biotherapeutics firm focused on pioneering treatments for inflammation, autoimmunity, and oncology, has announced that the United States Patent and Trademark Office (USPTO) granted it a new U.S. patent (No. 12,091,387). This patent includes claims covering compositions of matter and methods of use for ImmuneSensor's novel cGAS inhibitors, which target numerous inflammatory conditions such as autoimmune, cardiovascular, ocular inflammation, and neurodegenerative diseases.

This patent solidifies ImmuneSensor's proprietary approach to developing cGAS inhibitors, providing a significant edge in the competitive landscape. Tom Dubensky, Ph.D., President and CEO of ImmuneSensor, emphasized that the cGAS-STING pathway is a critical target for therapeutic interventions in inflammation and autoimmunity. Historically, drugging this pathway has been challenging, but this patent builds on foundational intellectual property created by Dr. James Chen, who initially defined the cGAS enzyme and its signaling molecule, cGAMP.

ImmuneSensor is preparing for a Phase 1 clinical trial in Australia for its leading cGAS inhibitor candidate, IMSB301. This trial will involve healthy volunteers and will assess the safety, tolerability, and pharmacokinetics of both single and multiple escalating doses of IMSB301. The company aims to proceed swiftly to Phase 1b/2 clinical studies in patients suffering from severe inflammatory diseases known as Type I interferonopathies.

IMSB301 is designed to inhibit the cGAS enzyme selectively, thereby reducing pathological inflammation. In preclinical studies, IMSB301 has shown potent inhibition of cGAS activity and a significant decrease in cytokine production. These findings are particularly promising for diseases driven by chronic cGAS activation, such as Aicardi Goutières Syndrome (AGS) and systemic lupus erythematosus (SLE).

AGS is a rare and severe genetic inflammatory disease that impacts both the brain and peripheral tissues. It results from mutations that lead to chronic production of type I interferon and other inflammatory cytokines due to continuous cGAS activation. There is currently no cure for AGS, and existing treatments only manage symptoms.

SLE is a complex autoimmune disease characterized by the dysregulated production of type I interferon and other cytokines, affecting multiple organs and systems. It can lead to severe organ damage and is more common in women, with the CDC estimating around 204,000 cases in the United States. Current treatments focus on anti-inflammatory and immunosuppressant drugs.

Cutaneous lupus erythematosus (CLE) is another autoimmune condition causing the immune system to attack skin cells, resulting in a red, scaly rash. Sunlight often triggers CLE, and it can also be a complication of SLE. Like AGS and SLE, CLE has no cure, and its symptoms are managed with drugs and lifestyle adjustments.

ImmuneSensor's development of IMSB301 aims to address these conditions by targeting the cGAS-STING pathway, with the potential to expand into other areas characterized by cGAS-driven inflammation, including diabetic kidney diseases and age-related macular degeneration.

ImmuneSensor Therapeutics, founded on Dr. Zhijian Chen's groundbreaking discovery of cGAS and cGAMP at the University of Texas Southwestern Medical Center, is dedicated to creating top-tier small molecule inhibitors and agonists of the cGAS-STING pathway. This strategic focus aims to meet significant unmet medical needs in autoimmunity, inflammation, and oncology.