Bavarian Nordic has formed a new partnership with AstraZeneca and Georgetown University to begin a Phase I/II clinical trial to evaluate CV301 and durvalumab (Imfinzi) in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancers.
Durvalumab is developed by AstraZeneca as a human monoclonal antibody directed against PD-L1 PD-L1 inhibitor.
As part of the new partnership, both Bavarian Nordic and AstraZeneca will provide a clinical trial material and financial support for the trial.
Georgetown University will sponsor the trial, which will be led by Georgetown University Medical Centre Lombardi Comprehensive Cancer Centre Department of Hematology / Oncology Assistant professor Dr Michael Pishvaian.
The proposed trial will include a lead-in study that intends to determine the safety and tolerability of the combination, as well as recommended Phase II dose of durvalumab in combination with CV301 and chemotherapy.
Phase II of the study will feature two parallel trials, as well as enrolling up to 26 patients for each disease setting.
The trial's primary objective is progression-free survival (PFS), while the secondary endpoints include objective response rate (ORR), overall survival (OS), and disease control rate (DCR).
Pishvaian said: “Colorectal and pancreatic cancers are among the most difficult-to-treat malignancies to date.
“While therapeutic options for these patients remain limited, combining a targeted cancer vaccine with a checkpoint inhibitor could result in a novel approach to fighting these diseases, as well as improved patient outcomes.”
In addition, Bavarian is currently investigating its targeted immunotherapy candidate CV301 in combination with other immune checkpoint inhibitors, including Merck’s Keytruda (pembrolizumab) in non-small cell lung cancer and Tecentriq (atezolizumab) from Roche in bladder cancer.