Aduro Biotech has started dosing patients in a Phase Ib clinical trial of its drug candidate ADU-S100 (MIW815) in combination with Novartis’ PDR001 to treat advanced / metastatic solid tumours or lymphomas.
ADU-S100 is a synthetic, small molecule, immune modulator of STING pathway, while PDR001 is an investigational PD-1 checkpoint inhibitor.
The multi-centre, open-label dose escalation and dose expansion Phase Ib trial is designed to assess the safety and efficacy of the combination in around 175 subjects across the US, Europe, Canada, Australia and Japan.
Aduro Biotech chief medical officer Natalie Sacks said: “We are pleased with our early progress in the ongoing Phase I dose escalation trial of ADU-S100 as a single agent and are eager to expand our investigation into a separate clinical trial to evaluate the effect of ADU-S100 used in combination with the PDR001 checkpoint inhibitor.
“As a leader in STING activation, we look forward to gaining more insight into the potential therapeutic application of this novel combination therapy.”
The dose escalation part of the trial will include two treatment schedules, of which one group will be administered with fixed-dose intravenous PDR001 on day 1 and intratumoural ADU-S100 three times in a 28-day cycle.
Another group will be given fixed-dose intravenous PDR001 on day 1 and intratumoural ADU-S100 on day 1 of each 28-day cycle.
The expansion part of the trial will be initiated after determination of a maximum tolerated dose and / or recommended dose.
Aduro signed a collaboration and licence agreement with Novartis in 2015 to research, develop and commercialise immuno-oncology products using its STING pathway activator platform technology.
The firm is further studying safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumour activity of ADU-S100 in an ongoing multi-centre, dose escalation Phase I trial.
Image: Micrograph of Hodgkin lymphoma, a type of lymphoma. Photo: courtesy of Nephron via Wikimedia.