Circio Holding ASA announced that the first patient has been dosed in the collaborative phase 2 trial sponsored by Georgetown University. In this study, mutant RAS cancer vaccine TG01 is being tested in combination with daratumumab (anti-CD38, Janssen) and nivolumab (anti-PD1, BMS) in patients with RAS-mutated pancreatic cancer (PDAC) and patients with non-small cell lung cancer (NSCLC). Mutations in the RAS-family of genes are a major cause of cancer and found in over 90% of PDAC and 30% of NSCLC cancer patients.

RAS-mutated cancers typically have poor prognosis with few targeted treatment alternatives, and the medical need for novel therapeutic options remains high. To further study this unmet medical need, a phase 2 trial has been initiated to test the combination of daratumumab (Janssen), nivolumab (BMS) and TG01 in advanced PDAC and anti-PD1 resistant NSCLC. The study will enroll 54 KRAS-mutated patients in total, 27 immunotherapy-naive PDAC patients and 27 NSCLC patients who have progressed on prior anti-PD1 therapy.