EBV-CTL, tabelecleucel (formerly ATA 129, ATA129)

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Company Q BioMed Inc.
DescriptionEpstein-Barr virus (EBV)-specific cytotoxic T lymphocytes
Molecular Target Not available
Mechanism of ActionCell therapy
Therapeutic ModalityCell therapy: Immune cells
Latest Stage of DevelopmentPhase III
Standard Indication Cancer (unspecified)
Indication DetailsTreat Epstein-Barr virus (EBV)-associated lymphomas and lymphoproliferative disorders in patients who are ineligible for any other trials of cell therapy; Treat Epstein-Barr virus (EBV)-positive lymphoproliferative disease and EBV-associated malignancies following allogeneic hematopoietic stem cell transplantation (HSCT); Treat Epstein-Barr virus (EBV)-positive malignancies; Treat Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV-PTLD)
Regulatory Designation U.S. - Breakthrough Therapy (Treat Epstein-Barr virus (EBV)-positive lymphoproliferative disease and EBV-associated malignancies following allogeneic hematopoietic stem cell transplantation (HSCT));
U.S. - Expanded Access (Treat Epstein-Barr virus (EBV)-associated lymphomas and lymphoproliferative disorders in patients who are ineligible for any other trials of cell therapy);
U.S. - Orphan Drug (Treat Epstein-Barr virus (EBV)-positive lymphoproliferative disease and EBV-associated malignancies following allogeneic hematopoietic stem cell transplantation (HSCT));
EU - Advanced Therapy Medicinal Product (ATMP) (Treat Epstein-Barr virus (EBV)-positive malignancies);
EU - Advanced Therapy Medicinal Product (ATMP) (Treat Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV-PTLD));
EU - Orphan Drug (Treat Epstein-Barr virus (EBV)-positive lymphoproliferative disease and EBV-associated malignancies following allogeneic hematopoietic stem cell transplantation (HSCT));
EU - PRIority MEdicines (PRIME) (Treat Epstein-Barr virus (EBV)-positive lymphoproliferative disease and EBV-associated malignancies following allogeneic hematopoietic stem cell transplantation (HSCT))
PartnerAtara Biotherapeutics Inc.

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$33.0M


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