DALLAS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- ImmuneSensor Therapeutics, a clinical-stage biotherapeutics company focused on the development of first- and best-in-class cGAS inhibitors to address diverse peripheral and CNS indications in inflammation and autoimmunity, today announced that it has dosed its first patient with IMSB301 in a Phase 1b clinical study being conducted in Australia in patients with genetically defined mutations which drive Aicardi Goutières Syndrome (AGS) and other Type 1 interferonopathies. IMSB301 is a novel, potentially best-in-class, orally available small molecule cGAS inhibitor.
The company recently completed a successful randomized, double-blinded, placebo-controlled Phase 1a study in healthy volunteers, which demonstrated a broad dose range of safety and tolerability for chronic dosing, dose-dependent and predictable pharmacokinetics and exposure, and inhibition of the cGAS target. Notably, IMSB301 exposure and inhibition of cGAS in the Phase 1a study were at levels that correlated with significant long-term benefit in animal models of AGS. The Phase 1a study results informed the dosing regimen in the ongoing Phase 1b clinical study, which is predicted to achieve optimal IMSB301 target inhibition. Additionally, the company announced previously that it received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for IMSB301 from the U.S. Food and Drug Administration (FDA) and subsequently received notice from FDA that it qualified for a Priority Review Voucher (PRV), issued at the time of drug approval. The ongoing Phase 1b trial is expected to enroll up to six patients in ultra-rare AGS and interferonopathies indications.
“The advancement into a selected patient population in a disease known to be driven by chronically activated cGAS represents a significant milestone for the company, and a strategy to rapidly demonstrate the clinical activity of IMSB301,” said Tom Dubensky, Ph.D., ImmuneSensor’s president and chief executive officer. “We expect to have top-line results from this Phase 1b study later this year, which, if positive, would provide the company with broad options to rapidly advance IMSB301 towards approval in AGS to take advantage of its Orphan Drug Designation, as well as to advance IMSB301 in multiple other potential cGAS-driven indications.”
“I am very excited to be able to evaluate a potential therapy that directly inhibits the disease-causing target in my AGS patients, for whom there are no approved therapies,” commented Professor Russell Dale, M.D., head of the Clinical Neuroimmunology group, Kids Neuroscience Centre, The Children's Hospital at Westmead, University of Sydney, Australia, and a global AGS key opinion leader who is the principal investigator of the Phase 1b clinical study. “My laboratory has already shown that IMSB301 profoundly reduces the Interferon Gene Signature (ISG) when incubated overnight with the first patient’s whole blood in vitro, providing us with significant anticipation and optimism for the ongoing Phase 1b clinical study.”
Additional details of the ongoing clinical study are available on clintrials.gov (NCT07364513).
About Aicardi Goutières Syndrome (AGS) and other Type I interferonopathies
AGS is a rare, severe, genetic inflammatory disease in pediatric and adult populations, affecting the brain (demyelination) and peripheral tissues (lungs, liver, heart and skin), caused by germline mutations, including TREX-1, that trigger chronic production of Type I interferon (IFN-I) and NF-κB pro-inflammatory cytokines resulting from chronic activation of cGAS. The disease has no cure and is currently treated with drugs designed to manage symptoms.
About IMSB301
The cGAS-STING pathway works to detect (“sense”) both host-derived and foreign cytoplasmic DNA produced as a result of infection or cell damage due to inflammation or malignancy. In autoimmune diseases, the innate immune response is chronically activated, directly promoting inflammation and the development of autoimmunity. IMSB301 is a novel, orally available small molecule designed to specifically inhibit the cGAS enzyme and halt pathologic inflammation. In preclinical studies, IMSB301 has demonstrated potent and specific inhibition of cGAS enzymatic activity that results in a profound suppression of cytokine production and rescue of the disease phenotype and premature death in a model of AGS. ImmuneSensor is developing IMSB301 initially in cGAS-driven Type I interferonopathies, including AGS. IMSB301 has the potential to address multiple other peripheral and CNS therapeutic areas that are characterized by cGAS-driven inflammation. IMSB301 has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA) and subsequently received notice from FDA that it qualified for a Priority Review Voucher (PRV), issued at the time of drug approval.
About ImmuneSensor Therapeutics
ImmuneSensor is a privately held, clinical-stage company founded on the groundbreaking discovery of cGAS and cGAMP along with their combined role in regulating immunity, by Dr. Zhijian “James” Chen’s laboratory at the University of Texas Southwestern Medical Center. This breakthrough has profoundly impacted both the scientific and pharmaceutical fields and earned Dr. Chen the 2024 Albert Lasker Basic Medical Research Award, and most recently the 2026 Japan Prize in Life Sciences. ImmuneSensor is dedicated to developing best-in-class small molecule inhibitors of the cGAS-STING signaling pathway to potentially address therapeutic areas with significant unmet medical need in autoimmunity and inflammation. For more information about ImmuneSensor, visit: www.immunesensor.com.
Contacts:
Investors
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
Business Development and Partnering
Dan Ross
dross@immunesensor.com
