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Galera Therapeutics, Inc. (Nasdaq: GRTX), headquartered in Malvern, Pennsylvania, is a clinical-stage biopharmaceutical company dedicated to transforming radiotherapy in cancer through innovative therapeutics. The company is currently focused on the development and commercialization of two primary product candidates: avasopasem manganese (avasopasem) and rucosopasem manganese (rucosopasem).
Avasopasem, a selective dismutase mimetic, has been developed to reduce radiation-induced severe oral mucositis (SOM) in patients with head and neck cancer. Despite receiving Fast Track and Breakthrough Therapy designations from the FDA, the company's New Drug Application (NDA) for avasopasem was met with a Complete Response Letter, requiring additional clinical trials for resubmission.
Rucosopasem aims to enhance the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Though rucosopasem has been granted orphan drug designation by the FDA, the company recently made the difficult decision to halt the Phase 2b GRECO-2 trial and the Phase 1/2 GRECO-1 trial due to a futility analysis of the GRECO-2 trial.
Following these setbacks, Galera has taken decisive steps to extend its cash runway, including workforce reductions and shifting focus towards strategic alternatives such as partnerships, mergers, and asset sales. As of the latest financial updates, the company estimates its balance of cash, cash equivalents, and marketable securities to support operations into the second quarter of 2024. Galera is actively evaluating these strategic options to maximize shareholder value while continuing its mission to improve cancer treatment outcomes.
For more information, visit the Investors page of Galera’s website.
Galera Therapeutics (GRTX) announced results from the Phase 3 ROMAN trial of avasopasem for severe oral mucositis (SOM) in head and neck cancer patients. The primary endpoint of reducing SOM incidence was not met, showing only a 16% reduction (54% vs. 64%) without statistical significance (p=0.113). However, secondary endpoints indicated a 56% reduction in duration of SOM (8 days vs. 18 days, p=0.011) and a 27% reduction in severity (Grade 4 OM). Avasopasem was well tolerated compared to placebo. The company continues to analyze results and explore next steps for its pipeline, including GC4711.
Galera Therapeutics, Inc. (Nasdaq: GRTX) has announced the appointments of Mark J. Bachleda as Chief Commercial Officer and Jennifer Evans Stacey as Chief Legal and Compliance Officer. Both executives bring over 25 years of experience in the biopharmaceutical industry. Bachleda, previously with Bristol Myers Squibb, will focus on the commercialization of avasopasem, a treatment for severe oral mucositis in cancer patients. Stacey, formerly at The Wistar Institute, will lead legal and compliance efforts. These hires come as Galera aims to transition into a commercial-stage company.
Galera Therapeutics (Nasdaq: GRTX) announced a virtual Key Opinion Leader event to discuss radiotherapy-induced severe oral mucositis (SOM) in head and neck cancer patients. The event is scheduled for Thursday, September 23, 2021, at 11:00 a.m. ET, featuring Dr. Carryn Anderson from the University of Iowa, alongside testimonials from survivors and insights from Galera's CEO, Mel Sorensen, M.D. The company’s lead candidate, avasopasem manganese, is in a Phase 3 ROMAN trial, expected to report results in the fourth quarter of 2021. The event will be accessible via Galera’s investor website.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced promising results from its Phase 1/2 trial evaluating GC4419 in patients with locally advanced pancreatic cancer. The study showed significant improvements in overall survival (HR=0.48), progression-free survival (HR=0.46), local tumor control (HR=0.30), and time to distant metastasis (HR=0.39). Notably, 46% of patients treated with GC4419 were alive at last follow-up compared to 33% in the placebo group. The trial's positive outcomes support the ongoing GRECO-2 Phase 2b trial, which aims to further assess GC4711's efficacy.
Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company, announced that Mel Sorensen, M.D., will present at three virtual investor conferences in September 2021. The events include the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, and the Cantor Fitzgerald Global Healthcare Conference on September 29. Live webcasts will be available on Galera's Investors page, with archived versions accessible for 30 days thereafter.
Galera Therapeutics (GRTX) announced the completion of enrollment in its pivotal Phase 3 ROMAN trial for avasopasem, aimed at treating severe oral mucositis in head and neck cancer patients, with topline data expected in Q4 2021. An interim analysis of a 42-patient pancreatic cancer trial showed nearly doubled median overall survival (20.1 months) compared to placebo (10.9 months). Additionally, the company initiated the GRECO-2 trial for pancreatic cancer. Financial results for Q2 2021 included a net loss of $22.4 million and total assets of $115.3 million, boosted by $57.5 million in milestone payments from Blackstone Life Sciences.
Galera Therapeutics (GRTX) announced the completion of enrollment in its pivotal Phase 3 ROMAN trial for avasopasem, aimed at treating severe oral mucositis (SOM) in head and neck cancer patients undergoing radiotherapy. This milestone triggers a $37.5 million payment from Blackstone Life Sciences. Approximately 70% of patients receiving radiotherapy for head and neck cancer develop SOM, and there are currently no approved treatments. Topline data is expected in the second half of 2021, with the potential for regulatory approval and commercialization.
Galera Therapeutics (Nasdaq: GRTX) announced that CEO Mel Sorensen will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 4:00 p.m. ET. A live webcast will be available on Galera's Investors page, with an archived version accessible for 30 days post-event. Galera is focused on developing innovative therapeutics for cancer treatment, with lead candidate avasopasem manganese aimed at reducing radiation-induced severe oral mucositis. The company has multiple ongoing clinical trials and received FDA Fast Track and Breakthrough Therapy designations for avasopasem.
Galera Therapeutics (Nasdaq: GRTX) has initiated the Phase 2b GRECO-2 trial for GC4711, aimed at treating locally advanced pancreatic cancer in combination with SBRT. This milestone marks the dosing of the first patient and triggers a $20 million payment from Blackstone Life Sciences. The trial is designed to evaluate overall survival as the primary endpoint, with secondary objectives including progression-free survival and safety. Previous trials indicated a significant survival benefit, with patients receiving GC4711 showing nearly double the overall survival compared to the control group.
Galera Therapeutics (GRTX) announced the publication of a study in Science Translational Medicine, showcasing the synergy between its dismutase mimetic, avasopasem manganese, and high-dose radiotherapy in cancer treatment. The research indicates that this combination enhances the effectiveness of radiation, leading to nearly double the median overall survival for patients with locally advanced pancreatic cancer in clinical trials. Galera is advancing multiple clinical trials for avasopasem and its second candidate, GC4711, targeting various cancers.
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