On February 1, 2024 Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA and immunotherapy medicines, reported that the first patient has been dosed in the collaborative phase 2 trial sponsored by Georgetown University (Press release, Circio, FEB 1, 2024, View Source [SID1234639773]). 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).
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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 (see announcement Nov 16 2023). The study will enroll 54 KRAS-mutated patients in total, 27 immunotherapy-naïve PDAC patients and 27 NSCLC patients who have progressed on prior anti-PD1 therapy.
Ola Melin, Head of the TG program at Circio, said: "The externally sponsored clinical program with our enhanced TG01 cancer vaccine is progressing well. The Georgetown study is now the third active clinical trial with patients on treatment, and comes in addition to the multiple myeloma study at Oslo University Hospital and the pancreatic cancer study at Kansas University. Collaborations are the core of the TG01 development strategy, and we are continuing to execute on the plan to advance our KRAS program through external development in multiple settings and geographies."