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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 [...]
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 [...]
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 [...]
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. [...]
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 [...]
Therapeutics based on messenger RNA, or mRNA, can potentially treat a wide range of maladies, including cancer, genetic diseases, and as the world has learned in recent years, deadly viruses. To work, these drugs must be delivered directly to target cells in nanoscale bubbles of fat called lipid nanoparticles, or LNPs — mRNA isn’t [...]
Scientists at St. Jude Children’s Research Hospital have developed a method that may be able to improve CAR T-cell therapies by identifying the early cells that become effective at killing cancer. St. Jude Children’s Research Hospital scientists have demonstrated that the long-term performance of cancer-killing chimeric antigen receptor (CAR) T cells can, in some cases, be predicted [...]
The University of Rochester Medical Center (URMC) and Sana Biotechnology have entered into an agreement which will allow Sana to expand its manufacturing footprint and create new job opportunities in Rochester. Sana, a company focused on creating and delivering engineered cells as medicines, also operates in Seattle, Cambridge, and South San Francisco. The company has programs [...]
A paper from the Horae Gene Therapy Center at UMass Chan Medical School may settle a longstanding debate about how to best manufacture adeno-associated virus (AAV) vectors for gene therapy. The paper, published online in the journal Human Gene Therapy, describes using AAV genome population sequencing (AAV-GPseq) to explore the genomes of vectors produced by two [...]
