QBiotics Group, a life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, has dosed the first patient in the Phase Ib/IIa clinical trial of its lead oncology molecule, tigilanol tiglate, in combination with MSD’s immune checkpoint inhibitor KEYTRUDA (pembrolizumab).
The trial is testing the combinations for patients with unresectable melanoma.
The QB46C-H06 multi-centre, open-label study will enrol approximately 22 patients with Stage IIIB to IV M1c-melanoma across a number of Australian sites over 24 months.
The study will test up to three intratumoral doses of tigilanol tiglate at three escalating dose levels, administered three weeks apart in combination with intravenous KEYTRUDA administered every three weeks for up to 24 months.
The study will evaluate the safety, optimal dose and tumour response of the tigilanol tiglate and KEYTRUDA combination in patients with late-stage unresectable melanoma, who have been previously exposed to immune checkpoint inhibitors.
Dr Victoria Gordon, the managing director and CEO of QBiotics, said, “We are very pleased to be collaborating with MSD in the fight against melanoma, a deadly form of skin cancer prevalent worldwide, but especially so here in Australia."
Dr Gordon continued “Patients with unresectable melanoma who have received prior checkpoint inhibitors currently have limited effective treatment options. We hope to see that when combined, tigilanol tiglate and KEYTRUDA may produce additive anti-tumour immune responses, improving outcomes for patients.”
“The commencement of this trial with our first patient dosed is a significant milestone for QBiotics and is underpinned by positive outcomes from our Phase I QBC46-H01 Phase I study using tigilanol tiglate as a monotherapy in 22 patients with a broad range of refractory solid tumours. In this Phase I study a single injection of tigilanol tiglate showed an injected tumour response rate of 60% (CR of 20%, PR of 28%, SD of 12%).5 Non-injected (abscopal) responses in distal tumours were observed in two patients with melanoma,” added Dr Gordon.