Aduro BioTech has treated first patient with its CRS-207 and GVAX pancreas cancer vaccine (GVAX pancreas) in the phase 2 trial.
The controlled, randomized trial which enrolls 90 patients is designed to assess the overall survival as well as the safety and immune response.
CRS-207 is based on Aduro’s platform of attenuated Listeria monocytogenes (Listeria) strains and is designed to induce cytotoxic T cells specific for the tumor-associated antigen mesothelin.
GVAX vaccines are composed of allogeneic (not patient-specific) cancer cell lines that have been genetically-modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to stimulate the immune system and that have been treated to prevent cell division.
The company said GVAX Pancreas when administered with low-dose cyclophosphamide has shown to increase effectiveness.
Aduro showed that sequential administration of GVAX Pancreas followed by CRS-207 was synergistic in mouse models, demonstrating enhanced tumor-specific T cell immune responses.
The company claims that because both GVAX Pancreas and CRS-207 target the tumor-associated antigen mesothelin, the sequential administration is a heterologous prime-boost regimen.
Three pancreatic cancer patients who had been treated with GVAX Pancreas as part of separate clinical trials were included in the CRS-207 Phase 1 clinical trial, based on the synergy in preclinical animal models.
All three of these end-stage patients survived 15 months or longer.