Galera Therapeutics, Inc. is 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. Galera announced that data from its double-blind, placebo-controlled pilot Phase 1b/2a clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) for locally advanced pancreatic cancer has been selected for presentation during the Late-breaking Special Session at the virtual 2020 ASTRO Annual Meeting, October 25-28, 2020.
GC4419 is an investigational, highly selective small molecule superoxide dismutase mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen. Details of the presentation are as follows: Abstract Title: “Randomized, Double-Blinded, Placebo-controlled Multicenter Adaptive Phase 1-2 Trial of GC4419, a Dismutase Mimetic, in Combination with High Dose Stereotactic Body Radiation Therapy (SBRT) in Locally Advanced Pancreatic Cancer (PC)” Session Title: SS 19 – Late-breaking Special Session Session Date: Tuesday, October 27, 2020 Session Time: 3-4:15 p.m. EDT Presenter: Cullen Taniguchi, MD, MD Anderson Cancer Center.
Galera’s lead product candidate, avasopasem manganese, is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic that is initially being developed for the reduction of radiation-induced severe oral mucositis (SOM), which is not yet approved. Avasopasem is designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen, protecting normal tissue from damage associated with radiation therapy. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy.
Avasopasem is currently being studied in the ROMAN trial, a randomized, double blind, placebo controlled Phase 3 trial of approximately 450 patients (NCT03689712, available at clinicaltrials.gov) to investigate the effects of avasopasem on radiation-induced OM in patients with locally advanced head and neck cancer. In Galera’s 223-patient, double-blind, randomized, placebo-controlled Phase 2b trial in patients with locally advanced head and neck cancer receiving concurrent radiation therapy, avasopasem produced a statistically significant reduction in duration of severe oral mucositis (SOM) from 19 days to 1.5 days (92 percent) in the 90 mg treatment arm. Avasopasem also demonstrated clinically meaningful reductions in SOM incidence through completion of radiation by 34 percent and in the severity of OM (incidence of Grade 4 OM) by 47 percent in the 90 mg treatment arm. The overall adverse event profile of avasopasem in the Phase 2b trial was similar to that of placebo and consistent with the known adverse effects of chemoradiation, with reductions of blood cell counts, particularly low lymphocyte counts, the most prominent adverse effects. Adverse events considered attributable to avasopasem were limited to mild, transient postural light-headedness or decreased blood pressure. Patients were followed for two years after enrollment and showed no difference in tumor outcomes between active and control, consistent with expectations for combinations with intensity-modulated radiation therapy (IMRT)/cisplatin, suggesting that the efficacy of the chemoradiation therapy was not
Avasopasem is also currently being studied in a Phase 2a trial for its potential to reduce the incidence of radiation-induced esophagitis in patients with lung cancer (NCT04225026, available at clinicaltrials.gov); and completed enrollment in a pilot Phase 1/2 trial (NCT03340974, available at clinicaltrials.gov) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer.
The U.S. Food and Drug Administration granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.Back To Top
ASTRO 20: Galera Presents Initial Trial Data on GC4419 Combined With SBRT for Pancreatic Cancer . Appl Radiol.