GC4419

Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis

Retrieved on: 
Monday, December 12, 2022

The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.

Key Points: 
  • The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.
  • “Approximately 42,000 patients with HNC undergo standard-of-care radiotherapy every year in the U.S. and are at risk of developing SOM.
  • Meaningful reduction in the number of patients who developed the most severe form of SOM (Grade 4) was also observed.
  • Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem, or GC4419) is being evaluated for radiotherapy-induced toxicities.

Galera to Present at Piper Sandler Annual Healthcare Conference

Retrieved on: 
Tuesday, November 22, 2022

MALVERN, Pa., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), 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, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29, 2022 at 11:10 a.m. E.T.

Key Points: 
  • MALVERN, Pa., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), 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, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29, 2022 at 11:10 a.m. E.T.
  • A live webcast of the presentation will be accessible from the Investors page of Galeras website, investors.galeratx.com .
  • Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer.
  • Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com .

Galera Reports Third Quarter 2022 Financial Results and Recent Corporate Updates

Retrieved on: 
Wednesday, November 9, 2022

MALVERN, Pa., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), 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, today announced financial results for the third quarter ended September 30, 2022 and provided recent corporate updates.

Key Points: 
  • The meta-analysis of the already positive results from both the ROMAN and GT-201 trials underscores that avasopasem improves SOM across these measures.
  • Research and development expenses were $8.1 million in the third quarter of 2022, compared to $14.8 million for the same period in 2021.
  • General and administrative expenses were $4.9 million in the third quarter of 2022, compared to $5.5 million for the same period in 2021.
  • As of September 30, 2022, Galera had cash, cash equivalents and short-term investments of $42.8 million.

Galera to Present at 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting

Retrieved on: 
Monday, September 26, 2022

Additionally, poster presentations will highlight the Phase 2 EUSOM trial of avasopasem for SOM in Europe and the ongoing GRECO-1 trial of rucosopasem for non-small cell lung cancer.

Key Points: 
  • Additionally, poster presentations will highlight the Phase 2 EUSOM trial of avasopasem for SOM in Europe and the ongoing GRECO-1 trial of rucosopasem for non-small cell lung cancer.
  • Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer.
  • Galeras selective dismutase mimetic product candidate avasopasem manganese (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities.
  • This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Galera to Participate in the H.C. Wainwright 24th Annual Global Investment Conference

Retrieved on: 
Tuesday, September 6, 2022

A live webcast of the presentation will be accessible from the Investors page of Galeras website, investors.galeratx.com .

Key Points: 
  • A live webcast of the presentation will be accessible from the Investors page of Galeras website, investors.galeratx.com .
  • An archived version of the webcast will be available in the Events & Presentations section of the Investors page of Galeras website for 30 days following the event.
  • Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer.
  • Galeras selective dismutase mimetic product candidate avasopasem manganese (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities.

Galera Appoints Eugene P. Kennedy, M.D., F.A.C.S., as Chief Medical Officer

Retrieved on: 
Thursday, September 1, 2022

I am honored to join Galera during this pivotal time in the Companys history, and I look forward to working with, and gaining insight from, Jon in the coming months, said Eugene P. Kennedy, M.D., F.A.C.S., Galeras Chief Medical Officer.

Key Points: 
  • I am honored to join Galera during this pivotal time in the Companys history, and I look forward to working with, and gaining insight from, Jon in the coming months, said Eugene P. Kennedy, M.D., F.A.C.S., Galeras Chief Medical Officer.
  • Before joining Galera, Dr. Kennedy served as Chief Medical Officer at Innovative Cellular Therapeutics, where he was an integral part of developing the Phase 1 clinical protocol and filing a first-in-human IND for a solid tumor CAR T-cell therapy.
  • Previously, he served as Chief Medical Officer at Lumos Pharma, where he was responsible for clinical development strategy and execution, as well as investor and patient outreach.
  • Prior to Lumos, Dr. Kennedy served as Chief Medical Officer at NewLink Genetics, where he oversaw clinical trials across multiple product candidates and indications.

Galera Reports Second Quarter 2022 Financial Results and Recent Corporate Updates

Retrieved on: 
Tuesday, August 9, 2022

MALVERN, Pa., Aug. 09, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), 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, today announced financial results for the second quarter ended June 30, 2022 and provided recent corporate updates.

Key Points: 
  • An oral presentation on Phase 3 ROMAN data of avasopasem for SOM was given at the 2022 ASCO Annual Meeting.
  • Research and development expenses were $6.7 million in the second quarter of 2022, compared to $16.0 million for the same period in 2021.
  • General and administrative expenses were $5.3 million in the second quarter of 2022, broadly consistent with the second quarter of 2021.
  • As of June 30, 2022, Galera had cash, cash equivalents and short-term investments of $52.0 million.

Galera Announces Results from Phase 1 Stage of GRECO-1 Trial of Rucosopasem with SBRT for NSCLC

Retrieved on: 
Wednesday, June 29, 2022

MALVERN, Pa., June 29, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), 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, today announced results from the open-label Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) in patients with centrally located or large non-small cell lung cancer (NSCLC). Enrollment is ongoing in the randomized, double-blinded, placebo-controlled Phase 2 stage of the trial, with completion of enrollment anticipated in the second half of 2023.

Key Points: 
  • The initial results from the Phase 1 stage of GRECO-1 demonstrate a promising safety profile for the rucosopasem and SBRT combination in patients with NSCLC, said Mel Sorensen, M.D., Galeras President and CEO.
  • We look forward to seeing how the combination performs compared to SBRT alone in the ongoing Phase 2 stage of this trial.
  • The primary endpoint of the Phase 2 stage of the trial is in-field (i.e., SBRT target) tumor response at six months post SBRT.
  • Patients are also being followed for long-term anti-cancer endpoints and safety similar to the Phase 1 stage of the trial.

Galera to Present at Jefferies Healthcare Conference

Retrieved on: 
Thursday, June 2, 2022

A live webcast of the presentation will be accessible from the Investors page of Galeras website, investors.galeratx.com .

Key Points: 
  • A live webcast of the presentation will be accessible from the Investors page of Galeras website, investors.galeratx.com .
  • Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer.
  • Galeras selective dismutase mimetic product candidate avasopasem manganese (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities.
  • Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com .

Galera Announces Oral Presentation at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting Detailing Results from Phase 3 ROMAN Trial of Avasopasem

Retrieved on: 
Thursday, May 26, 2022

MALVERN, Pa., May 26, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), 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, today announced data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis will be highlighted in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on Friday, June 3, 2022 from 2:45 p.m. – 5:45 p.m. CDT during the Head and Neck Cancer session. Topline data was announced in December 2021. Abstracts are currently available in the ASCO digital program.

Key Points: 
  • We are pleased that our Phase 3 trial of avasopasem was selected for an oral presentation at ASCO, where details of the clinically meaningful and statistically significant results will be shared, said Mel Sorensen, M.D., Galeras President and CEO.
  • Exploratory analyses, such as time to SOM onset and SOM incidence at various landmarks of radiotherapy delivered, also demonstrated clinical benefit of avasopasem in reducing the burden of SOM.
  • These results are consistent with those from the positive 223-patient Phase 2b trial (Anderson, J Clin Oncol, 2019) that was the basis for Breakthrough Therapy Designation.
  • Galeras selective dismutase mimetic product candidate avasopasem manganese (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities.