Date: 2016-03-16
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the American Association for Cancer Research (AACR) Annual Meeting
Company: Atara Biotherapeutics (USA - CA)
Product: EBV-CTL (allogeneic Epstein-Barr virus cytotoxic T lymphocytes)
Action
mechanism: cell therapy/immunotherapy product. Atara's EBV-CTL utilizes a technology in which T-cells are collected from the blood of third-party donors and then exposed to EBV antigens. The resulting activated T-cells are then expanded, characterized, and stored for future therapeutic use in an appropriate partially human leukocyte antigen, or HLA, matched patient, providing an "off-the-shelf", allogeneic, cellular therapeutic option for patients.
Disease: EBV-associated nasopharyngeal carcinoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On June 6, 2016, Atara Biotherapeutics announced that its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) reported clinical results for Atara's allogeneic Epstein-Barr Virus Cytotoxic T-Lymphocyte (EBV-CTL) product candidate. Data were presented from an on-going Phase 2 clinical trial, which enrolled a heterogeneous group of EBV associated malignancies including NPC and post-transplant lymphoproliferative disorders, at an oral presentation at the ASCO 2016 Annual Meeting. This data included safety and efficacy of EBV-CTL in the treatment of 14 patients with recurrent metastatic nasopharyngeal carcinoma (NPC). EBV-associated NPC accounts for approximately 6,000 cases annually in the US and EU combined and approximately 80,000 cases worldwide. Historical median survival rates range from five to eleven months for patients with metastatic disease. * On March 16, 2016, Atara Biotherapeutics announced that its collaborating investigators at QIMR Berghofer Medical Research Institute will present data on autologous targeted EBV-CTLs in a Clinical Trials Minisymposium Session at the American Association for Cancer Research (AACR) 2016 Annual Meeting. The presentation will report clinical results on the use of EBV-CTLs to treat patients with EBV-associated nasopharyngeal carcinoma (NPC).
Dr. Susan Prockop, M.D., and colleagues reported the following data:
A 21% objective response rate in NPC patients, including one complete response, and two partial responses.
11 of the 14 NPC patients were alive with median 18-month follow-up.
EBV-CTLs expanded after administration to immunocompetent NPC patients without concomitant lymphodepleting chemotherapy.
Of the 126 patients enrolled across all indications, there were two grade 4 and seven grade 3 possibly related serious adverse events.
In October 2015, Atara Bio and QIMR Berghofer entered into exclusive license and research agreement under which Atara Bio has exclusive, worldwide rights to develop and commercialize allogeneic, or "off-the-shelf", CTLs targeted to multiple epitopes of the Epstein-Barr virus utilizing technology developed by QIMR Berghofer. Atara Bio anticipates filing an IND for allogeneic targeted EBV-CTLs in 2017. In addition, Atara Bio has an option to license the autologous targeted EBV-CTL product candidate from QIMR Berghofer.
The presentation is titled "Therapeutic and Prophylactic AdE1-LMPpoly-Based Adoptive T cell Immunotherapy for Epstein—Barr Virus-Associated Nasopharyngeal Carcinoma" (abstract).
