QBiotics 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.5 6 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.
QBiotics' leading anticancer pharmaceutical, EBC-46 (tigilanol tiglate), 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.7
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*. Tigilanol tiglate administration 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 drugs mode of action resulting in a transient (1-2 days) localised swelling and pain*. 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*.
MCT is a common solid tumour in dogs and the demand for an alternative or adjunctive therapy to current treatment options is high.
Current first-line treatment of MCT in dogs is surgical removal of the 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;
- Pivotal Field Efficacy Study in the USA, under the Food and Drug Administration Centre for Veterinary Medicine (FDA-CVM), commenced in 2017 and is in final stages of completion;
- Method and controls for manufacturing the active pharmaceutical ingredient have been evaluated by the FDA-CVM and drug product evaluation by this regulatory body will commence early 2018..
Applications for marketing approval are expected to be finalised in the near future, with the first launch planned for 2019. Our objective is that tigilanol tiglate will be a useful first-line option for both general and specialist veterinarian to treat MCT in dogs.
QBiotics is also investigating soft tissue sarcoma as a second indication for us of tigilanol tiglate in dogs. A Pivotal Field Efficacy Study is currently underway in the UK, France and Germany to support registration of the drug in Europe.
5 Kelsey JL, et al. (1998) Epidemiological studies of risk factors for cancer in pet dogs. Epidemiology Review 20 (2):204-217.
6 Withrow SJ. and Vail DM. (2007) Small Animal Clinical Oncology, Elsevier Inc, Canada 402-421.
7 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