Targovax ASA (OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces that TG02 has passed the initial planned safety review in the phase Ib clinical mechanism-of-action trial evaluating TG02, and TG02 in combination with the checkpoint inhibitor KEYTRUDA® (pembrolizumab), in patients with confirmed RAS-mutated colorectal cancer.
The safety review was carried out on the initial three patients enrolled in the first cohort, who are treated with TG02 as monotherapy. No issues were reported, and it has been recommended that the trial should continue. This is the first time TG02, the second generation RAS neo-antigen vaccine from the Company’s proprietary TG platform, has been administered to patients. In February, the Company published positive two-year survival data from TG01, its first generation vaccine from this platform, in resected pancreatic cancer.
Early exploratory clinical results indicate that TG02 induces immune response in patients, with high activation status of tumor-infiltrating T-cells compared to historical controls. In addition, PD-1 expression was observed in both circulating and tumor-infiltrating T-cells. This further strengthens the rationale for combining TG02 with PD-1 checkpoint blockade. Based on these initial safety and immune activation findings, the Company and investigators will discuss the appropriate timing for switching into the KEYTRUDA®combination part of the trial, and start recruiting patients into the second cohort.
Magnus Jäderberg, Chief Medical Officer of Targovax said: “This is the first time TG02 has been administered to patients, and we are very pleased that there were no issues reported in this initial safety review. The early clinical data is also encouraging, indicating immune activation in vaccinated patients in a manner that is consistent with the drugs postulated mechanism of action. We are now eager to initiate the combination trial with KEYTRUDA®, and we are hopeful that PD-1 blockade might boost the effect of TG02 vaccination.”
This TG02 trial is a multi-site, open-label, non-randomized phase Ib exploratory trial, that will enrol approximately 20 patients with locally recurrent rectal cancer, where specific poor-prognosis mutations in the RAS gene have been confirmed. The study consists of two cohorts of up to 10 patients each. The first cohort will receive TG02 and granulocyte macrophage colony stimulating factor (GM-CSF) as monotherapy, and the second cohort will in addition to this receive the PD-1 checkpoint inhibitor, KEYTRUDA®. The primary objective of the study is to assess the safety of TG02 in this setting. In addition, the impact of TG02 vaccination on systemic and local innate and adaptive immune responses of treated patients will be evaluated. The trial is currently enrolling patients at sites in Australia and New Zealand.