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Galera Therapeutics is a privately held, clinical-stage biotechnology company focused on discovering and developing novel therapeutics targeting oxygen metabolic pathways with the potential to transform how radiation therapy is used in patients with cancer.
Galera's lead product candidate is GC4419, a highly selective and potent small molecule superoxide dismutase enzyme mimetic that rapidly converts superoxide to hydrogen peroxide and oxygen. Radiation therapy generates elevated superoxide levels that can damage non-cancerous tissues and lead to debilitating side effects that may limit the anti-tumor efficacy of radiation therapy.
GC4419 has been studied in patients with head and neck cancer for it's ability to reduce the incidence and duration of radiation-induced severe oral mucositis (SOM). In addition, multiple preclinical studies, GC4419 has demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.
The FDA has granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence, and severity of SOM induced by radiation therapy with or without systemic therapy. It has also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.
The rest of Galera's portfolio consist of other dismutase mimetic product candidates, both in clinical and earlier stage.
