NEW YORK – Akamis Bio on Thursday said that its gene therapy NG-350A will be studied with Bristol Myers Squibb's checkpoint inhibitor Yervoy (ipilimumab) and standard-of-care chemotherapy in a platform trial involving advanced pancreatic cancer patients being conducted by the Parker Institute for Cancer Immunotherapy and the Cancer Research Institute.
PICI and CRI launched the REVOLUTION trial in 2021 to test various immunotherapy combinations as first-line treatments for metastatic pancreatic cancer. Akamis' NG-350A, a gene therapy product designed to activate antigen-presenting cells in tumors and lymph nodes through CD40, will be given with Yervoy and gemcitabine/paclitaxel to previously untreated patients with metastatic pancreatic cancer in cohort C of the REVOLUTION trial. Researchers will evaluate the safety and clinical activity of the regimen as well as biomarkers of response.
Since 2018, Oxfordshire, UK-based Akamis Bio and PICI have been working together to study therapies developed using Akamis' T-SIGn platform, which are based on a replication competent, chimeric group B adenovirus backbone adapted to home in on tumor tissue. PICI has invested in Akamis as part of this collaboration. Now, CRI has also made a financial contribution and provided operational support, allowing for the inclusion of Akamis' NG-350A in the REVOLUTION trial.
Outside of this platform study, Akamis' internal development program for NG-350A includes two Phase I clinical trials. In the Phase Ia/Ib FORTITUDE study, the company is studying the safety, tolerability, and preliminary efficacy of NG-350A in patients with metastatic or advanced epithelial tumors. In the Phase Ia/Ib FORTIFY study, Akamis is evaluating NG-350A with Merck's Keytruda (pembrolizumab) in that same setting.
"Pancreatic cancer is one of the most complex and difficult to treat cancers. The wide variety of cell types, molecular pathways, and immune resistance mechanisms involved in the development and progression of the disease make it nearly impossible to treat with a single agent," Robert Vonderheide, director of the Abramson Cancer Center at Penn Medicine and lead investigator of the REVOLUTION study, said in a statement. "We look forward to further exploring the CD40 agonist mechanism of action for people with pancreatic cancer who are in dire need of additional treatment options."