US-based clinical-stage biopharmaceutical company Corvus has reported positive pre-clinical and preliminary biomarker data from its ongoing Phase I/Ib trial of CPI-444, both as a single agent and combined with Genentech’s Tecentriq (atezolizumab) to treat cancer.

Corvus’ CPI-444 has been developed as an orally administered antagonist of the adenosine A2A receptor. It blocks the action of adenosine produced by tumours.

Genentech’s Tecentriq is a fully humanised, monoclonal antibody developed to target protein programmed cell death ligand 1 (PD-L1).

The first dose-escalation part of the trial was conducted in four cohorts for a period of 28 days involving 12 patients suffering from non-small-cell lung cancer, melanoma, renal cell cancer, triple-negative breast cancer, colorectal cancer, head and neck cancer, bladder cancer and prostate cancer.

"We believe this is the first demonstration of immune modulation in cancer patients receiving an adenosine antagonist."

Three cohorts treated patients with single agent CPI-444 while one cohort administered a combination of CPI-444 and Tecentriq.

The second part of the study will test CPI-444 as a single agent, which will be administered in five disease-specific cohorts, and CPI-444 in combination with TECENTRIQ in five additional matched disease-specific cohorts.

Preclinical study results have suggested the efficacy of CPI-444, both as a single agent and in combination with anti-PD-1 and anti-PD-L1 antibodies, in triggering anti-tumour immunity and suppressing tumour progression in animal models of cancer.

After analysing patients with various solid tumours, the preliminary biomarker data demonstrated CPI-444 in blocking peripheral blood lymphocyte A2A receptors.

Pharmacodynamic markers on peripheral blood lymphocytes exhibited activation of T-cell mediated immunity in all three patients treated with CPI-444, which was also well-tolerated throughout the analysis.

Corvus oncologist, co-founder, president and CEO Richard Miller said: “We are very encouraged by the early data showing that CPI-444 is well tolerated, and by the biomarker data indicating that treatment with CPI-444 as a single agent is associated with activation of T-cells detected in the blood.

“We believe this is the first demonstration of immune modulation in cancer patients receiving an adenosine antagonist.”