MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) recently announced that Science Translational Medicine has published a foundational preclinical article describing the synergy of avasopasem manganese, one of the Company’s selective dismutase mimetics, with high fraction dose radiotherapy, such as stereotactic body radiation therapy (SBRT) or stereotactic ablative radiotherapy (SAbR), in killing tumors.
The research, a collaboration between scientists at University of Texas Southwestern, University of Iowa and Galera, is part of the basis for two ongoing clinical trials with the Company’s dismutase mimetics in combination with SBRT in pancreatic cancer and lung cancer. Galera recently reported clinical results from its placebo-controlled Phase 1/2 pilot trial, showing that the combination of its selective dismutase mimetic with SBRT nearly doubled the median overall survival of patients with locally advanced pancreatic cancer (LAPC).
“We are gratified to have these results published in Science Translational Medicine describing the strong scientific rationale which underpin the promising clinical data seen in our pancreatic cancer trial,” said Mel Sorensen, M.D., President and CEO of Galera. “We thank our research collaborators who have helped us lay out the novel scientific basis for this potentially groundbreaking therapy for patients.”
The publication, “Avasopasem manganese synergizes with hypofractionated radiation to ablate tumors through the generation of hydrogen peroxide,” reports from preclinical cell and tumor models that the selective dismutase mimetic — by converting superoxide produced as a byproduct of radiotherapy into hydrogen peroxide — increased cancer cell killing with radiation. The synergy between the mimetic and radiotherapy increased with larger daily doses (“fractions”) of radiation.
Moreover, in the range of fraction sizes typical of SBRT, the combination ablated many of the tumors. In addition, as previously published, the authors report that by removing the superoxide, the dismutase mimetics protected normal cells from radiation toxicity. These two separate benefits of the dismutase mimetics with radiotherapy act through the differential responses to superoxide and hydrogen peroxide by normal cells and cancer cells and are at the core of Galera’s clinical programs.
Consistent with the publication, Galera recently reported updated clinical results from a randomized, placebo-controlled Phase 1/2 pilot trial in which a near doubling of median overall survival was observed in patients with LAPC treated with a dismutase mimetic combined with SBRT versus placebo plus SBRT. Final results from this trial are expected in the second half of 2021. Building on the pilot trial, the Company expects to open the randomized Phase 2b GRECO-2 trial of GC4711, its second dismutase mimetic product candidate, in combination with SBRT in patients with LAPC in the first half of this year.
Galera’s Phase 1/2 GRECO-1 trial of GC4711 is ongoing, testing its dismutase mimetic in combination with SBRT for patients with non-small cell lung cancer.
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