Our Company
QBiotics has more than a 20 year track record in applying a scientifically-based, data-driven approach to the discovery of novel, plant-derived small molecule scaffolds for applications in human and animal health using our proprietary discovery platform EcoLogic™.
Our current focus is on two unique clinical assets in oncology and wound healing
We have two interrelated programmes in oncology and wound healing which we are co-developing for both the human and companion animal markets.
Oncology
(tigilanol tiglate)
Our lead oncology product, tigilanol tiglate, is a novel small molecule that is administered intratumourally and has "pan-tumour" activity with the potential to treat a broad range of solid tumours, either as a monotherapy or in combination with checkpoint inhibitor drugs.
Two human Phase II clinical trials are in progress investigating tigilanol tiglate in patients with Head and Neck Cancers and Soft Tissue Sarcoma.
Commercialised Veterinary Pharmaceutical
Tigilanol tiglate has been registered and is marketed (branded as STELFONTA®*) as a veterinary pharmaceutical for the treatment of canine mast cell tumours in the USA, EU, UK and Australia. Additional veterinary trials are in progress to determine the efficacy of tigilanol tiglate in other solid tumours and other species.
(*This link will take you to a product site that contains information that may not comply with the Australian regulatory requirements.)
Wound Healing
EBC-1013
Our lead wound healing molecule, EBC-1013, is a novel, semi-synthetic small molecule formulated as a topical gel. Preclinical models and veterinary trials show it has the potential to treat a wide range of difficult to treat wounds including chronic non-healing and traumatic acute wounds, as well as burns. This programme is currently in the early clinical stage of development for veterinary applications and a Phase I trial in patients with venous leg ulcers is planned for 2023.
We have proven ability to successfully partner and to commercialise our products
The potential of our products, and the quality of the underpinning science, is recognised in our commercial partnerships with leading global pharmaceutical companies.
STELFONTA*, the veterinary formulation of our oncology drug tigilanol tiglate, has been approved for the treatment of canine mast cell tumours in the USA, EU, UK and Australia, and is being marketed and distributed under an agreement with Virbac, a global animal health company.
We also have a clinical collaboration with MSD (tradename of Merck & Co. Inc, Kenilworth, NJ, USA) to evaluate the use of tigilanol tiglate in combination with their immune checkpoint inhibitor KEYTRUDA® (pembrolizumab) in patients with unresectable melanoma.
(*This link will take you to a product site that contains information that may not comply with the Australian regulatory requirements.)
Our Story
2000
2000
EcoBiotics established to discover novel, biologically active chemicals from Queensland's tropical rainforest2000
Effectiveness of our EcoLogic™ discovery platform independently validated2003
Bioactive extract libraries built for 5 major therapeutic indications2002-2004
Agreements for access to privately-owned rainforest for biodiscovery negotiated with landholders2004
Benefit sharing agreement signed with Queensland Government allowing access to state-owned rainforest lands for biodiscovery2004
QBiotics Limited established as a subsidiary to EcoBiotics to hold intellectual property2005
Tigilanol tiglate (EBC-46) discovered as an anticancer compound2005
2006
Shiseido discovery agreement2006
Tigilanol tiglate patent applications progress to examination phase in all major regions2007
Symrise AG discovery agreement2007
Tigilanol tiglate mode of action identified2008
Johnson & Johnson discovery agreement2008
Initial veterinary clinical case studies with tigilanol tiglate2009-2013
Tigilanol tiglate canine exploratory cases>200 cases (89 MCT)
2010
2010
Human and veterinary clinical development programmes for tigilanol tiglate commenced2010-2014
Tigilanol tiglate patents granted in all major markets2013
Dose characterisation study of tigilanol tiglate for treatment of canine mast cell tumours (MCTs) completed2014
First patient treated with tigilanol tiglate in human clinical Phase I/IIa trial2015
2015
IND enabling toxicology programme completed meeting requirements for both human and veterinary programmes2015
US pivotal field efficacy and safety trial for tigilanol tiglate in treatment of canine MCTs completed2017
QBiotics Group established following merger between EcoBiotics and QBiotics2018
Agreement with Virbac for marketing & distribution of tigilanol tiglate as a veterinary pharmaceutical in EU, UK and USA2019
Regulatory submission to the European Medicines Agency for tigilanol tiglate as a treatment for canine MCTs2019
Tigilanol tiglate Phase I/IIa human safety trial completed2019
First patient treated with tigilanol tiglate in human Phase Ib/IIa trial for head and neck squamous cell carcinoma2019
Regulatory submission to US FDA Center for Veterinary Medicine for tigilanol tiglate as a treatment for canine MCTs2019
Regulatory submission to Swissmedic for tigilanol tiglate as a treatment for canine MCTs2019
Regulatory submission to the Australian Pesticides and Veterinary Medicines Authority for tigilanol tiglate as a treatment for canine MCTs2020
2020
EMA approval and EU market launch of tigilanol tiglate for treatment of canine MCTs2020
Clinical collaboration agreement with Merck Sharp & Dohme for trialling tigilanol tiglate in combination with Keytruda®2020
Swissmedic approval for tigilanol tiglate as a treatment for canine MCTs2020
Food and Drug Administration, Center for Veterinary Medicine (FDA-CVM) approval received for STELFONTA2021
US Launch of STELFONTA as a treatment for canine MCTs2021
First human patient dosed with tigilanol tiglate in combination with KEYTRUDA® (pembrolizumab).2021
APVMA approval for tigilanol tiglate as a treatment for canine MCTs2022
STELFONTA launched in Australia as a treatment for canine MCTs