Gene & Cell Therapy Testing

13 09, 2022

Kyverna Therapeutics’ $85 million series B financing reflects significant investor confidence in the science behind cell therapies

2024-07-10T19:49:38+00:00

Kyverna Therapeutics, a cell therapy company engineering a new class of therapies for serious autoimmune diseases, today announced it has closed an oversubscribed $85 million Series B financing round led by Northpond Ventures. Additional investors included the company’s founding investors Westlake Village BioPartners (“Westlake”), Vida Ventures, and Gilead Sciences (“Gilead”), with new investors RTW [...]

Kyverna Therapeutics’ $85 million series B financing reflects significant investor confidence in the science behind cell therapies2024-07-10T19:49:38+00:00
30 08, 2022

First allogeneic cell therapy candidate engineered to target cd19 for b-cell malignancies receives IND clearance, will proceed to clinical trials

2024-07-10T19:49:27+00:00

Century Therapeutics, an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the company has been notified by the U.S. Food and Drug Administration (FDA) that the Company’s ELiPSE-1 clinical study may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is [...]

First allogeneic cell therapy candidate engineered to target cd19 for b-cell malignancies receives IND clearance, will proceed to clinical trials2024-07-10T19:49:27+00:00
23 08, 2022

FDA approves the first gene therapy for people with beta-thalassemia who require regular red blood cell transfusions

2024-07-10T19:27:05+00:00

bluebird bio has announced the the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. “The FDA approval of ZYNTEGLO offers people with [...]

FDA approves the first gene therapy for people with beta-thalassemia who require regular red blood cell transfusions2024-07-10T19:27:05+00:00
9 08, 2022

How gene therapy can cure or treat diseases

2024-07-10T19:31:26+00:00

The genes in your body’s cells play a key role in your health. Indeed, a defective gene or genes can make you sick. Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition. [...]

How gene therapy can cure or treat diseases2024-07-10T19:31:26+00:00
2 08, 2022

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing

2024-07-10T19:49:08+00:00

Effort to address challenges to the manufacturing scale-up of cell-based therapies follows release of Project A-Gene for gene therapy in 2021 The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing BioPharmaceuticals (NIIMBL) today released Project A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case [...]

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing2024-07-10T19:49:08+00:00
10 05, 2022

FDA issues new draft guidelines on genome editing and CAR-T therapy

2024-07-13T13:28:34+00:00

On March 15th, 2022 the FDA is announcing the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing,” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The draft guidance, “Human Gene Therapy Products Incorporating Human Genome Editing,” is intended to provide recommendations to sponsors [...]

FDA issues new draft guidelines on genome editing and CAR-T therapy2024-07-13T13:28:34+00:00
4 05, 2022

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients

2024-07-10T19:30:59+00:00

Graphite Bio is a clinical-stage, next-generation gene editing company harnessing the power of high-efficiency precision gene repair to develop therapies with the potential to treat or cure serious diseases. The FDA has just granted Fast Track Designation to GPH101 for the treatment of sickle cell disease (SCD). GPH101 is an investigational next-generation gene-edited autologous [...]

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients2024-07-10T19:30:59+00:00
3 02, 2022

Mission Bio Transfers First Tapestri GMP-Ready CGT Assay to Avance Biosciences™ for Cell-Based Therapies

2024-08-09T18:09:35+00:00

GMP-compliant test for transduction efficiency marks a key milestone for Tapestri’s ability to power single-cell analysis in clinical trial settings for cell & gene therapies SOUTH SAN FRANCISCO, February 2, 2021 -- Mission Bio, the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced today the first tech transfer of a clinical trial-ready cell [...]

Mission Bio Transfers First Tapestri GMP-Ready CGT Assay to Avance Biosciences™ for Cell-Based Therapies2024-08-09T18:09:35+00:00
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