At QBiotics, the current focus for animal health is cancer.
Cancer is very common in our companion animals. Worldwide as many as 1 in 4 dogs and 1 in 6 cats will develop cancer at some time in their life, and almost 50% of dogs over the age of 10 years will die of the disease.1 2 To date, there are only a very small number of registered treatments for cancer in companion animals, providing a significant opportunity for new treatments in this growing market.
The company's leading anticancer pharmaceutical, tigilanol tiglate (EBC-46), is a novel small molecule diterpene ester in development for the local treatment of mast cell tumours (MCT) and soft tissue sarcomas (STS) in dogs.
Tigilanol tiglate was discovered by applying the EcoLogic™ approach to drug discovery from the tropical rainforests of Australia. The drug is not synthetically tractable and is isolated from the Australian native plant Blushwood.
Tigilanol tiglate is a protein kinase C (PKC) activator and when injected into solid tumours causes PKC-dependent tumour haemorrhagic necrosis, rapid tumour cell death and overall tumour destruction with good site healing as demonstrated in pre-clinical models of cancer.3
Treatment of advanced spontaneous tumours
QBiotics has already demonstrated evidence of tigilanol tiglate’s efficacy and safety by successfully treating advanced, spontaneous tumours in companion animals that were considered untreatable with current standards of care*. In this setting a single intra-tumoural injection of tigilanol tiglate resulted in tumour destruction within 5 to 7 days and good wound healing in approximately 28 days in the majority of cases.1 Tigilanol tiglate administration usually does not require the use of local or general anaesthetics and is generally well tolerated with the main side effects being a function of the drug's mode of action, resulting in a transient (1-2 days) localised swelling and pain.1 In cases where the limb is involved, treatment with tigilanol tiglate may avoid the need for limb amputation, and good cosmetic outcomes post-tumour removal result in minimal or no scarring, which are obvious benefits for the affected animal and their owners.1
Treatment of mast cell tumours (MCT)
MCT is a common solid tumour in dogs and the demand for an alternative or adjunctive therapy to existing treatment options is high.
Current first-line treatment of MCT in dogs is the surgical removal of cancer. In cases where surgery alone is not feasible or unlikely to be successful, one or a combination of, chemotherapy, radiotherapy or cytoreductive surgery is undertaken. Dependent on the size and location of the cancer, current surgical options may result in significant disfigurement, such as limb amputation or significant scarring. Current treatments for MCT are often costly and may not be readily available to dogs in remote areas.
* Data on file QBiotics
QBiotics is in late-stage development of tigilanol tiglate for the treatment of MCT in dogs:
- Clinical trials have established the dose and treatment regimen for the drug
- A pivotal Field Efficacy Study in the USA, under the Food and Drug Administration Centre for Veterinary Medicine (FDA-CVM), was completed in 123 dogs across 11 sites. The clinical trial results have been submitted to the FDA-CVM and European Medicines Authority(EMA) as integral to the efficacy submission for a proposed canine MCT indication.
- Method and controls for manufacturing the active pharmaceutical ingredient have been evaluated by the FDA-CVM
Applications for marketing approval are in progress for Europe, the United Kingdom, USA and Australia. Our objective is for tigilanol tiglate to be available globally to primary care and specialist veterinarians as an option to treat MCT in dogs.
QBiotics is also investigating soft tissue sarcoma as a second indication for use of tigilanol tiglate in dogs. A pivotal field efficacy study is currently underway in UK, France and Germany to support registration of the drug globally.
Marketing and distribution partner - Virbac
QBiotics has signed an agreement with Virbac, one of the largest dedicated animal health companies globally, to market and distribute tigilanol tiglate. The agreement covers veterinary markets across the EU, UK and USA with the potential for future expansion to other focus territories including Australia. Virbac has the expertise and global footprint to maximise the commercial success of tigilanol tiglate.
1 Kelsey JL, et al. (1998) Epidemiological studies of risk factors for cancer in pet dogs. Epidemiology Review 20 (2):204-217.
2 Withrow SJ. and Vail DM. (2007) Small Animal Clinical Oncology, Elsevier Inc, Canada 402-421.
3 Boyle GM, et al. (2014) Intra-Lesional Injection of the Novel PKC Activator EBC-46 Rapidly Ablates Tumors in Mouse Models. PLoS ONE 9(10): e108887. doi:10.1371/journal.pone.0108887