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Editas Medicine Announces Positive Safety and Efficacy Data from the First Two Patients Treated in the RUBY Trial of EDIT-301 for the Treatment of Severe Sickle Cell Disease

Retrieved on: 
Tuesday, December 6, 2022

CAMBRIDGE, Mass., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical stage genome editing company, today announced positive, initial clinical data from the first two patients with sickle cell disease (SCD) treated with EDIT-301 in the Phase 1/2 RUBY trial. EDIT-301 is under development for the treatment of severe sickle cell disease. The clinical data includes safety data from the first two patients and efficacy data from the first patient treated.

Key Points: 
  • The clinical data includes safety data from the first two patients and efficacy data from the first patient treated.
  • Additionally, neither patient has experienced any vaso-occlusive events since treatment with EDIT-301, at five and 1.5 months follow up, respectively.
  • EDIT-301 is an experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
  • The RUBY trial is a single-arm, open-label, multi-center Phase 1/2 study designed to assess the safety and efficacy of EDIT-301 in patients with severe sickle cell disease.

Editas Medicine to Host Virtual Event to Highlight Initial Clinical Data from the RUBY Trial of EDIT-301 for Severe Sickle Cell Disease

Retrieved on: 
Thursday, December 1, 2022

The clinical data will include safety data from the first two patients and efficacy data from the first patient treated with EDIT-301.

Key Points: 
  • The clinical data will include safety data from the first two patients and efficacy data from the first patient treated with EDIT-301.
  • In sickle cell disease, the red blood cells are misshapen in a sickle shape instead of a typical disc shape.
  • EDIT-301 is an experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
  • The RUBY trial is a single-arm, open-label, multi-center Phase 1/2 study designed to assess the safety and efficacy of EDIT-301 in patients with severe sickle cell disease.

Editas Medicine Announces Clinical Achievements in the Development of EDIT-301 for Sickle Cell Disease

Retrieved on: 
Wednesday, July 27, 2022

CAMBRIDGE, Mass., July 27, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced the dosing and confirmed successful neutrophil and platelet engraftment of the first patient in the Phase 1/2 RUBY trial of EDIT-301 for the treatment of severe sickle cell disease (SCD). This dosing is the first time that the Company’s engineered AsCas12a enzyme, a proprietary, highly efficient, and specific gene editing nuclease, has been used to edit human cells in a clinical trial.

Key Points: 
  • It is an exciting time at Editas as we continue to build momentum for our EDIT-301 program, said Gilmore ONeill, M.B., M.M.Sc., President and CEO, Editas Medicine.
  • Sickle cell disease is an inherited blood disorder caused by a mutation in the beta-globin gene that leads to polymerization of the sickle hemoglobin protein (HbS).
  • In sickle cell disease, the red blood cells are misshapen in a sickle shape instead of the disc shape.
  • EDIT-301 is an experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

Editas Medicine Receives FDA Orphan Drug Designation for EDIT-301 for the Treatment of Beta Thalassemia

Retrieved on: 
Thursday, May 12, 2022

CAMBRIDGE,Mass., May 12, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to EDIT-301, an investigational, gene editing medicine, for the treatment of beta thalassemia.

Key Points: 
  • CAMBRIDGE,Mass., May 12, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to EDIT-301, an investigational, gene editing medicine, for the treatment of beta thalassemia.
  • The FDA previously granted Rare Pediatric Disease designation to EDIT-301 for the treatment of beta thalassemia and sickle cell disease.
  • Receiving Orphan Drug Designation for EDIT-301 for beta thalassemia highlights the urgent need for new treatment options for patients, said James C. Mullen, Chairman, President, and Chief Executive Officer, Editas Medicine.
  • Based on clinical severity and transfusion requirements, beta thalassemia can be classified into non-transfusion-dependent (NTDT) and transfusion-dependent beta thalassemia (TDT).

Editas Medicine Receives FDA Rare Pediatric Disease Designation for EDIT-301 for the Treatment of Beta Thalassemia

Retrieved on: 
Tuesday, April 26, 2022

CAMBRIDGE,Mass., April 26, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leadinggenome editing company, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease designation to EDIT-301, an investigational, gene-edited medicine for the treatment of beta thalassemia.

Key Points: 
  • CAMBRIDGE,Mass., April 26, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leadinggenome editing company, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease designation to EDIT-301, an investigational, gene-edited medicine for the treatment of beta thalassemia.
  • The FDA previously granted Rare Pediatric Disease designation to EDIT-301 for the treatment of sickle cell disease.
  • Receiving Rare Pediatric Disease designation for EDIT-301 for beta thalassemia highlights the dire need for new treatment options, said James C. Mullen, Chairman, President, and Chief Executive Officer, Editas Medicine.
  • The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years.

Editas Medicine Reports on Recent Progress and Outlook at J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 10, 2022

CAMBRIDGE, Mass., Jan. 10, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced that James C. Mullen, Chairman, President, and Chief Executive Officer, will discuss the Company’s recent progress and outlook for its gene editing medicines and platform technology at the 40th Annual J.P. Morgan Healthcare Conference being held virtually on Wednesday, January 12 at 10:30 a.m. EST.

Key Points: 
  • Using a dual-vector approach with a AsCas12a nuclease, Editas Medicine has enhanced productive editing by approximately 350% compared to the initial construct.
  • Editas Medicine has announced the development candidate EDIT-202, a highly differentiated, iPSC-derived natural killer cell (iNK) investigational medicine with double knock-in and double knock-out edits.
  • Editas Medicine continues to evaluate the application of its iPSC platform to additional cell types beyond iNK and alpha-beta T cells.
  • Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

Editas Medicine Announces FDA Clearance of Investigational New Drug (IND) Application for EDIT-301 for the Treatment of Transfusion-Dependent Beta Thalassemia

Retrieved on: 
Monday, December 20, 2021

CAMBRIDGE, Mass., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for EDIT-301 for the treatment of transfusion-dependent beta thalassemia (TDT), enabling the Company to initiate a Phase 1/2 clinical study of EDIT-301 in TDT patients.

Key Points: 
  • The FDAs clearance of our IND for EDIT-301 for TDT is an important milestone for Editas and for the patients we hope to serve.
  • With this IND clearance, Editas Medicine is preparing to initiate a Phase 1/2 trial designed to assess the safety, tolerability, and preliminary efficacy of EDIT-301 for the treatment of TDT.
  • Based on clinical severity and transfusion requirements, beta thalassemia can be classified into non-transfusion-dependent (NTDT) and transfusion-dependent beta thalassemia.
  • EDIT-301 is an experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

Editas Medicine to Present Data Demonstrating Progress Towards Transformative Gene Editing Medicines for the Treatment of Hemoglobinopathies and Cancer at the ASH Annual Meeting and Exposition

Retrieved on: 
Thursday, November 4, 2021

CAMBRIDGE, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced that two scientific abstracts have been accepted for presentation at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in Atlanta and virtually, December 11-14, 2021. The two abstracts outline preclinical data from the Company’s hemoglobinopathy and oncology programs. An additional oncology program abstract was published in Blood, the flagship journal of the American Society of Hematology.

Key Points: 
  • An additional oncology program abstract was published in Blood, the flagship journal of the American Society of Hematology.
  • Abstracts can be accessed on the ASH website and the presentations will be posted on the Editas Medicine website during the conference.
  • EDIT-301 is an experimental, autologous cell therapy medicine under investigation for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
  • Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

Editas Medicine Announces Second Quarter 2019 Results and Update

Retrieved on: 
Tuesday, August 6, 2019

Cash, cash equivalents, and marketable securities of $317.9 million as of June 30, 2019

Key Points: 
  • Cash, cash equivalents, and marketable securities of $317.9 million as of June 30, 2019
    CAMBRIDGE, Mass., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today reported business highlights and financial results for the second quarter of 2019.
  • Editas Medicine is developing EDIT-301 to directly upregulate fetal hemoglobin by editing the HBG1/2 promoter in the beta-globin locus.
  • The Company announced today the appointment of Cynthia Collins as President and Chief Executive Officer of Editas Medicine.
  • ET to provide and discuss a corporate update and financial results for the second quarter of 2019.