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."
Trial details
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 (ClinicalTrials.gov Identifier: NCT02933944). 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.
