QBiotics Group Limited, based in Queensland, has announced the Phase Ib/IIa clinical trial of 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.
Following the positive outcomes from the Phase I study using tigilanol tiglate as a monotherapy, the study will evaluate the safety, optimal dose and tumour response of the tigilanol tiglate and pembrolizumab combination in patients with late-stage unresectable melanoma, who have been previously exposed to immune checkpoint inhibitors.
The 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 intratumoural doses of tigilanol tiglate at three escalating dose levels, administered 3 weeks apart in combination with intravenous pembrolizumab administered every 3 weeks for up to 24 months.
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.”
Tigilanol tiglate is a plant-derived small molecule, administered by injection directly into a solid tumour. Injected tumours are rapidly destroyed by tumour cell necrosis, vascular disruption, and immune-mediated mechanisms. Pembrolizumab is a systemic immune checkpoint inhibitor, which reactivates the immune system by blocking the activity of PD-1, an immune checkpoint protein that prevents T cells from recognising and killing cancer cells.
Over the last decade, the global cases of melanoma have increased by nearly 50 percent, 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.
For more information bout the clinical trial: clinicaltrials.gov/ct2/show/NCT04834973
QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing pharmaceuticals for human and veterinary markets. Its lead molecule, tigilanol tiglate, is a small molecule anticancer pharmaceutical targeting a range of solid tumours across multiple species. QBiotics’ business model is to develop products that have application in both veterinary and human markets. Success in the veterinary programs validates QBiotics technology and de-risks human development, while generating early, non-diluting revenues.
About tigilanol tiglate
Tigilanol tiglate is a small molecule being developed as an intratumoural treatment for solid tumours. It has a multimodal action that involves injected tumour responses as well as systemic responses in non-injected tumours. Complete destruction of the injected tumour is mediated via tumour vascular disruption, death of tumour cells by oncosis and immune-mediated mechanisms.3 Following tumour destruction, rapid wound healing has been shown to ensue.