Australian company Noxopharm (ASX:NOX) has provided an update on the IONIC Investigator-initiated pilot Phase 1 clinical trial of its lead oncology drug candidate Veyonda.
IONIC is exploring the potential of Veyonda to increase the activity of Bristol Myers Squibb’s PBS-listed immune checkpoint inhibitor OPDIVO (nivolumab) in different types of cancer.
Noxopharm said the IONIC safety steering committee has reviewed the safety data from all evaluable patients in the trial.
It said the committee concluded that the 1,200-milligram dose was found to be safe and well tolerated, allowing enrolment to continue with the next patient cohort to be treated with an increased Veyonda dose of 1,800-milligram.
There are now six active trial sites in the Sydney area and regional NSW.
The company said the enrolment rate is proceeding according to the schedule with 11 patients enrolled and others in screening.
This trial is being led by principal investigator Professor Paul de Souza. Professor de Souza has research agreements with Bristol Myers Squibb and Noxopharm to conduct the trial, administering both Veyonda and OPDIVO to an ultimate target of approximately 30 patients.
Professor de Souza said, “The investigation of checkpoint inhibitor resistance is very important at a time when more and more patients are receiving these drugs. We are making good progress with this trial, and look forward to treating this next cohort of patients at the higher dose level.”
Noxopharm CEO Dr Gisela Mautner added, “We’re pleased that the enrolment of this trial has accelerated and a Veyonda dose of 1200mg is safe and well tolerated in combination with Opdivo. This trial is exciting as it is our first investigation into the combination of Veyonda with an immuno-oncology drug. Immuno-oncology is a relatively new but growing cancer therapy market, and patients who are resistant to these drugs are generally left with very few treatment options. Our overarching goal is to improve this situation.”