ATA129 is a cytotoxic T lymphocyte product candidate precision targeted against antigens expressed by the Epstein-Barr Virus (EBV). ATA129 is our most advanced development program and has received:
- Orphan and breakthrough designation from FDA
- Orphan and advanced therapy medicinal product (ATMP) designation from EMA
- Access to priority medicines regulatory support (PRIME) for the lead indication from EMA
ATA129 is ready to enter Phase 3 trials to support approval in two separate indications for EBV-PTLD, a hematologic malignancy:
- Rituximab refractory EBV-PTLD following allogeneic hematopoietic stem cell transplant – The MATCH Trial
- Rituximab refractory EBV-PTLD following solid organ transplant – The ALLELE Trial
Pursuant to parallel scientific advice from the EMA’s Scientific Advice Working Group and several national Health Technology Assessment, or HTA, agencies in the EU, in 2018, we plan to submit an application for Conditional Marketing Authorization, or CMA, for ATA129 in the treatment of patients with rituximab refractory EBV-PTLD following HCT. The CMA will be based on clinical data from Phase 1 and 2 trials conducted at MSK and supported by available data from our Phase 3 trials in rituximab refractory EBV-PTLD after HCT and SOT, which will be ongoing at the time of filing.
To complement the Phase 3 trials, we are conducting an expanded access trial for ATA129 that will enroll patients with a broad range of EBV associated tumors (such as Burkitt’s lymphoma, Hodgkin’s lymphoma, DLBCL) for which there is no comparable or satisfactory alternative therapy.
We have also begun to generate data utilizing ATA129 to treat nasopharyngeal carcinoma (NPC). Our collaborating investigator, MSK, presented clinical results at the June 2016 American Society of Clinical Oncology, or ASCO, meeting on the use of ATA129 in patients with NPC. We intend to continue to evaluate this product candidate in the treatment of NPC, and expect to initiate a Phase1/2 clinical trial evaluating ATA129 in combination with a checkpoint inhibitor for the treatment of NPC following the initiation of our ATA129 Phase 3 trials.