Galera Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, announced that the first patient has been dosed in the Phase 1/2 GRECO-1 clinical trial of GC4711 in combination with stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer (NSCLC).

GC4711, Galera’s second clinical candidate, is a highly selective small molecule superoxide dismutase (SOD) mimetic that is designed to rapidly convert superoxide to hydrogen peroxide and is being developed specifically for use in combination with SBRT. In preclinical studies, GC4711, when added to an SBRT regimen, increased the anti-cancer efficacy of radiotherapy and protected normal lung tissue.

The trial is supported in part by a recently awarded Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) for the investigation of Galera’s dismutase mimetics in combination with SBRT for the treatment of lung cancer. The grant was awarded by the NCI of the NIH under award number 4R44CA206795-02.

“SBRT holds promise to deliver more efficient, targeted and potent radiotherapy to improve cancer outcomes. This trial builds on the pilot trial in combination with SBRT in patients with locally advanced pancreatic cancer and we are eager to embark on our exploration of the potential of Galera’s GC4711 to enhance the anti-cancer efficacy of SBRT,” said Mel Sorensen, M.D., President and CEO of Galera. “We’re grateful for the support provided by the SBIR grant, which further recognizes the potential of this combination.”

Following a safety run-in cohort, up to 66 NSCLC patients with locally advanced disease will receive GC4711 with SBRT or placebo with SBRT over five consecutive weekdays in the randomized, double-blind, placebo-controlled Phase 2 portion of the GRECO-1 trial. The goals of this trial are to assess the effects of GC4711 in combination with SBRT on tumor outcomes and lung injury.

Galera’s product candidate, GC4711, is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic in development specifically for use in combination with stereotactic body radiation therapy (SBRT). GC4711 is designed to rapidly convert superoxide to hydrogen peroxide and is being developed to synergize with SBRT to exploit cancer cells’ increased sensitivity to hydrogen peroxide to promote cancer cell death. In preclinical studies, GC4711, when added to an SBRT regimen, increased the anti-cancer efficacy of radiotherapy at current doses. GC4711 successfully completed Phase 1a clinical trials in healthy volunteers, and is currently being studied in a Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer (NSCLC).