Artiva Biotherapeutics announced today that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application for AlloNK®, in combination with rituximab for treatment of systemic lupus erythematosus in patients with active lupus nephritis...
In a promising form of immunotherapy known as CAR T-cell (chimeric antigen receptor) therapy, the patient’s T cells are engineered to better recognize and attack antigens on the surface of cancer cells. In treatments currently approved for use in battling lymphoma and leukemia...
The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current...
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Preclinical data demonstrates that hypoimmune-modified allogeneic iPSCs evade immune response and rejection without immunosuppression in a non-human primate model and long-term survival and immune evasion was at least equivalent to the survival of autologous iPSCs...
The goal of the hypoimmune platform is to overcome the immunologic rejection of allogeneic cells, which if true for SC291 may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell lymphomas or leukemias. The hypoimmune platform includes disruption of major...
A recent study has shown remarkable results from compassionate use of CAR-T cell therapy to treat severe lupus in five patients in whom multiple other treatments had previously failed. CAR-T cell therapy involves genetically engineering T cells, a type of immune cell, so that they respond to a prespecified molecular marker, or antigen. This means they mount an immune response against cells with the chosen antigen...
Company files its first Investigational New Drug application for its lead program KYV-101, a novel fully human CD19 CAR T-cell therapy, for the treatment of lupus nephritis. Kyverna’s therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate...
Twice a year, the Alliance for Regenerative Medicine (ARM) surveys the cell and gene therapy landscape and ARM’s initiatives to advance the sector and provide an update to their members, their stakeholders, and the public at large. While external conditions ebb and flow, the sector’s progress — in clinical milestones, regulatory developments, and patient impact — steadily advances...
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 [...]
