Date: 2017-04-21
Type of information: Clinical research agreement
Compound: ATA129 and Keytruda® (pembrolizumab
Company: Atara Biotherapeutics (USA - CA) Merck&Co (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
- monoclonal antibody/immune checkpoint inhibitor/cell therapy. Keytruda® (pembrolizumab - MK-3475) is a highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Keytruda® is the first approved drug that blocks the PD-1 cellular pathway.
- Atara Bio's ATA129 is an investigational therapy in which a healthy donor's T-cells are stimulated to recognize EBV antigens, or viral proteins, expressed in the cells of certain liquid and solid tumors. ATA129 has previously been evaluated as a single agent in Phase 1 and 2 trials that enrolled patients with a variety of EBV-positive malignancies including 14 patients with chemotherapy refractory, metastatic nasopharyngeal carcinoma. In these trials, evidence of radiographic response was observed and EBV-CTLs were also shown to expand after administration without concomitant lymphodepleting chemotherapy. Recent studies suggest that EBV upregulates the transcription of PD-L1 in EBV-associated solid tumors such as nasopharyngeal carcinoma and gastric cancer, suggesting the potential for synergy in combination with anti-PD-1 therapies, such as Keytruda®.
Disease: platinum resistant or recurrent EBV-associated nasopharyngeal carcinoma
Details:
- • On April 21, 2017, Atara Biotherapeutics announced that it has entered into a clinical trial collaboration agreement with Merck &Co to evaluate Atara Bio's allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTL), or ATA129, in combination with Merck's anti-PD-1 (programmed death receptor-1) therapy, Keytruda® (pembrolizumab), in patients with platinum resistant or recurrent EBV-associated nasopharyngeal carcinoma. The Phase 1/2 trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination and is planned for initiation in 2018.
- Under the agreement, the trial will be sponsored by Atara Bio. Additional details of the collaboration were not disclosed.
Financial terms:
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Is general: Yes
