Dr
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 study.
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.
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Dr
victoria.gordon@qbiotics.com or + 61 418 453 737
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jane.lowe@irdepartment.com.au or +61 411 117 774
About QBiotics
QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing products for human and veterinary markets. Its lead product, tigilanol tiglate, is an 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. https://qbiotics.com
About Tigilanol tiglate
Tigilanol tiglate is a small molecule that is being tested as an intratumoural treatment for solid tumours. Its effect on tumours is multimodal and involves injected tumour responses as well as distal responses in non-injected tumours. Complete destruction of the injected tumour is mediated via tumour vascular disruption as well as death of tumour cells by oncosis1. Following tumour destruction, rapid wound healing has been shown to ensue.
A single injection of tigilanol tiglate has been shown in canine patients to ablate (completely destroy) 75% of treated tumours(3). Veterinary use of tigilanol tiglate (branded STELFONTA(R)) has received marketing authorisation by the
References
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.
3. De Ridder et al., (2020). Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate (EBC-46).
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