Tabelecleucel is under clinical development by Atara Biotherapeutics and currently in Phase III for Epstein–Barr Virus (HHV-4) Infections. According to GlobalData, Phase III drugs for Epstein–Barr Virus (HHV-4) Infections does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Tabelecleucel LoA Report. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Tabelecleucel (Ebvallo) is an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy. It is formulated as a dispersion for injection for the intravenous route of administration. Ebvallo is indicated as monotherapy for the treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.
ATA-129 is under development for the treatment of rituximab-refractory, Epstein-Barr Virus-Associated post-transplant lymphoproliferative disease (PTLD) after solid organ transplantation (SOT) and allogeneic hematopoietic cell transplantation (HCT), hemophagocytic lymphohistiocytosis, hodgkin lymphoma (b-cell hodgkin lymphoma), non-hodgkin lymphoma, solid tumor and lymphoproliferative disorders. Allogeneic EBV specific cytotoxic T- lymphocytes are administered as an intravenous infusion. It is developed based on allogeneic, or off-the-shelf, cytotoxic T-lymphocytes (CTLs) directed against multiple epitopes of the Epstein-Barr virus (EBVpoly) and multiple epitopes of the cytomegalovirus (CMVpoly) utilizing technology.
It was also under development for EBV associated gastric cancer, nasopharyngeal cancer, leiomyosarcoma and lymphomas.
Atara Biotherapeutics overview
Atara Biotherapeutics (Atara) is a biopharmaceutical company specialized in T-cell immunotherapy. The company uses its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop therapies for the treatment of cancers, other autoimmune diseases, and severe viral infections. It is evaluating its lead candidate, tabelecleucel in Phase III clinical trials for the treatment of Epstein Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) following hematopoietic cell transplant and solid organ transplant in patients who refracted rituximab. Its pipeline product candidates that are being developed for multiple indications in various stages of clinical trials include ATA188, ATA2271, ATA3219, ATA3271 and other CAR T programs. Atara is headquartered in South San Francisco, California, the US.
For a complete picture of Tabelecleucel’s drug-specific PTSR and LoA scores, buy the report here.