QBiotics-MSD commence combination drug trial in advanced melanoma

Pharma News: QBiotics, a life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, announced that it has dosed the first patient with the company’s lead oncology molecule, tigilanol tiglate in combination with MSD’s immune checkpoint inhibitor KEYTRUDA (pembrolizumab) for patients with unresectable melanoma, the deadliest form of skin cancer.

The Phase Ib/IIa clinical trial will enrol approximately 22 patients with Stage IIIB to IV M1c-melanoma across a number of Australian sites over 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, 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 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%. Non-injected (abscopal) responses in distal tumours were observed in two patients with melanoma,” said Dr Gordon.

Over the last decade, the global cases of melanoma have increased by nearly 50%, with more than 320,000 people diagnosed annually. This translates to approximately 60,000 melanoma-related deaths per year.

Australia has the highest melanoma rates in the world, with one person diagnosed every 30 minutes, and an estimated 1,300 deaths each year.