QBiotics Group Limited (QGL), a life sciences company developing novel anticancer and wound healing pharmaceuticals, is
pleased to announce that it has entered into an agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, NJ, USA), to evaluate use of its lead molecule tigilanol tiglate, in combination with
Keytruda(R) (pembrolizumab) in patients with unresectable melanoma.
Dr Victoria Gordon, Managing Director and CEO of QBiotics, said, "We are delighted to announce this collaboration with
MSD. Patients with unresectable melanoma who have received prior checkpoint inhibitors currently have limited effective
treatment options. Through this program we hope to see that when combined, tigilanol tiglate and Keytruda may produce
additive anti-tumour immune responses, and improve outcomes for patients."
The Phase I/II open label 'QBC46-H06' study is a dose escalation and expansion study with the primary objective of
determining the maximum tolerated dose or maximum feasible dose of the combination therapy. Secondary measures include
assessing tumour responses in both injected tumours and uninjected tumours, as well as clinical efficacy parameters.
Patients with unresectable melanoma and who have had exposure to immune checkpoint inhibitors are eligible for the
Dr Gordon continued, "This study follows on from encouraging Phase I data where tigilanol tiglate as a monotherapy
showed a 27% treatment response rate*, including an 18% complete response with full tumour destruction across a wide
variety of solid tumour types(2). Two patients with melanoma that had complete responses also had an abscopal
(anenestic) response. Melanoma is the second human application we are pursuing for tigilanol tiglate following on from
our Phase I/II clinical trial in patients with Head and Neck Squamous Cell Carcinoma (HNSCC) which commenced in December
Tigilanol tiglate is a small molecule administered by intratumoural injection directly into the solid tumour mass. Once
injected, it has a multi-modal action including (i) rapid, but highly localised, inflammatory responses, (ii) increased
permeability and destruction of tumour vascular endothelium, and (iii) rapid tumour cell death by oncosis(1).
*27% treatment response rate (n=6); 18% complete response rate (n=4)2.
1. Boyle et al., (2014) Intra-tumoural injection of the novel PKC activator EBC-46 rapidly ablates tumours in mouse
models. PLoS One 9:e1068887. DOI: 10.1371/journal.pone.0108887.
2. Panizza et al., (2019) Phase I dose-escalation study to determine the safety, tolerability, preliminary efficacy and
pharmacokinetics of an intra tumoural injection of tigilanol tiglate (EBC-46). EBioMedicine 50: 433-441.