August 29, 2016 7:52 PM ET

Biotechnology

Company Overview of Galera Therapeutics, Inc.

Company Overview

Galera Therapeutics, Inc., a clinical-stage biotechnology company, develops drugs targeting oxygen metabolic pathways. The company primarily focuses on the prevention of radiation-induced toxicity, including mucositis, and the treatment of cancer. Its small molecule dismutase mimetics mimics the activity of the human superoxide dismutase enzymes. The company was founded in 2009 and is based in Malvern, Pennsylvania.

2 West Liberty Boulevard

Suite 110

Malvern, PA 19355

United States

Founded in 2009

Phone:

610-725-1500

Key Executives for Galera Therapeutics, Inc.

Chief Executive Officer, President and Director
Age: 59
Founder, Chief Operating Officer and Director
Chief Financial Officer
Age: 67
Chief Medical Officer
Director of Business Development
Compensation as of Fiscal Year 2016.

Galera Therapeutics, Inc. Key Developments

Galera Therapeutics Announces Presentation at ASCO of Positive Results from Study of GC4419 for the Reduction of Severe Oral Mucositis

Galera Therapeutics, Inc. announced the presentation of data from a Phase 1b/2a clinical trial of GC4419, an investigational drug candidate for the reduction of chemoradiotherapy-induced oral mucositis (OM), at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Study results suggest that GC4419 may reduce the incidence, severity and duration of severe OM in patients receiving chemoradiation therapy for the treatment of head and neck cancer, particularly when GC4419 is administered for the duration of chemoradiation therapy. The Phase 1b/2a trial assessed the safety and pharmacokinetics of GC4419, administered intravenously prior to each dose of intensity modulated radiotherapy (IMRT) and cisplatin therapy, in 43 patients evaluable for OM. Study endpoints also included assessments of the incidence, time to onset, duration, and severity of OM and initial tumor outcomes for several dosing schedules of GC4419. The study demonstrated that, compared to historic controls, GC4419 appeared to delay onset, shorten the duration and decrease the incidence of severe OM (defined as WHO Grades 3 and 4 OM). The data also showed that the effect of GC4419 was greater if the treatment was administered for the entire duration of IMRT, with larger reductions in all grades of OM experienced by patients receiving full therapy (6-7 weeks) compared to patients receiving partial therapy (3 weeks). For example, investigators reported that the cumulative overall incidence of Grade 4 OM was 25% in patients in the 3 week cohort, while patients receiving full therapy had 0%. The median duration of severe OM was 2.5 days in patients receiving full therapy, far shorter than the 3-4 week duration in matched historical controls. Patients who received partial therapy still experienced less than 25% of the duration of severe OM than reported for matched historical controls. GC4419 had a safety profile consistent with the IMRT and cisplatin regimen. The most common adverse events were attributable to chemotherapy or head and neck cancer. The plasma half-life of GC4419 was approximately 1.5 hours, with minimal accumulation after repeated dosing. Only 4.3% of patients required breaks in IMRT of 5 consecutive fractions or more, as opposed to 15% in published reports of other studies of OM in comparable patients. Patients followed for up to 12 months after completion of IMRT have showed no evidence of tumor protection from GC4419 treatment, with follow-up ongoing.

Galera Therapeutics, Inc. Presents at Boston CEO Conference, Jun-01-2016 01:00 PM

Galera Therapeutics, Inc. Presents at Boston CEO Conference, Jun-01-2016 01:00 PM. Venue: Four Seasons Boston, 200 Boylston Street, Boston, MA 02116, United States. Speakers: Robert A. Beardsley, Founder, Chief Operating Officer and Director.

Galera Therapeutics Announces Fast Track Designation of GC4419 for Prevention of Oral Mucositis

Galera Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for GC4419, an investigational drug candidate, for the reduction of severity and incidence of radiation and chemotherapy induced oral mucositis (OM). Galera also announced that it has begun enrolling patients in a Phase 2b study of GC4419 for the reduction of OM in head and neck cancer (HNC) patients. The FDA Fast Track process is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. This designation provides for more frequent consultation between the FDA and the sponsor, as well as the potential "rolling review" of completed sections of the New Drug Application (NDA), and potential eligibility for accelerated approval and priority review. Based on Phase 1b/2a trial results of GC4419 in HNC patients receiving chemoradiation therapy, Galera has begun enrolling patients in a double-blind, randomized Phase 2b clinical trial to prevent OM in this setting.

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