• STELFONTA® (tigilanol tiglate) is now approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the treatment of canine non-metastatic mast cell tumours (MCT).
• APVMA approval follows marketing authorisation (registration) and launch of STELFONTA® in the major companion animal markets of the US, Europe, and the United Kingdom.
• STELFONTA® will be available to Australian veterinarians, including oncologists and general practitioners, in October 2021 through QBiotics' marketing and distribution partner, Virbac - a global animal health company.

BRISBANE, Australia, July 7, 2021 /PRNewswire/ -- QBiotics Group Limited (QBiotics), an Australian life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, is pleased to announce the Australian Pesticides and Veterinary Medicines Authority (APVMA) has approved* its lead veterinary product STELFONTA® (tigilanol tiglate). This approval represents Australia's first pharmaceutical treatment available for all grades of canine non-metastatic MCT.

STELFONTA® is indicated for the treatment of non-metastatic (WHO staging), cutaneous MCT (located anywhere on the body, legs or head in dogs), and non-metastatic subcutaneous MCT located at or distal to the elbow or hock in dogs. Tumours may be of any cytological grade, must be less than or equal to 10 cm³ in volume, and must be accessible to intratumoral injection.

QBiotics' CEO and Managing Director, Dr Victoria Gordon said "APVMA approval of STELFONTA® marks an important milestone for QBiotics. As an Australian company with a strong heritage in discovery, research and development, we are proud that our lead molecule will now be available to treat cancer in Australian dogs."

Approval for STELFONTA® is based on a QBiotics sponsored, pivotal, US multi centre, randomised, blinded and untreated controlled study in 123 canine patients with MCT. In this study, a single injection of STELFONTA® induced a 75% Complete Response (where the tumour is completely destroyed), compared to untreated control dogs (p=0.001). An 88% Complete Response was achieved with two injections. There was no tumour recurrence in 89% of evaluable cases 12 months post-treatment.[1]

Australian regulatory approval follows the marketing authorisation of STELFONTA® by the US Food and Drug Administration (FDA-CVM), European Medicines Agency (EMA), the Veterinary Medicines Directorate (VMD) in the United Kingdom and Swissmedic, with subsequent sales in all major markets.                   

STELFONTA® will be available to all Australian veterinarians, including oncologists and general practitioners, in October this year through QBiotics' marketing and distribution partner, the global animal health company, Virbac.

Dr Gordon said "QBiotics is also currently investigating tigilanol tiglate, the active pharmaceutical ingredient in STELFONTA®, in a series of human Phase I and Phase II clinical trials targeting head and neck squamous cell carcinoma, and melanoma as both a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor. Plans for a human clinical trial in soft tissue sarcoma are also underway.

QBiotics develops products simultaneously for the human and veterinary markets. Results from tigilanol tiglate canine studies not only underpinned the registration of a new veterinary anticancer product, they also inform our human clinical program. In addition, revenue from sales of STELFONTA® financially supports our human product development," said Dr Gordon.

* STELFONTA® (tigilanol tiglate injection) APVMA Application no.: 121236; Product registration no.: 88412 

ABOUT QBIOTICS

QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing pharmaceuticals for human and veterinary markets. Its lead molecule, tigilanol tiglate, is a small molecule 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^[1]

ABOUT TIGILANOL TIGLATE

Tigilanol tiglate is a small molecule being developed as an intratumoural treatment for solid tumours. It has a multimodal action that involves injected tumour responses as well as systemic responses in non-injected tumours. Complete destruction of the injected tumour is mediated via tumour vascular disruption, death of tumour cells by oncosis and immune-mediated mechanisms.¹ Following tumour destruction, rapid wound healing has been shown to ensue. A human clinical Phase I tigilanol tiglate monotherapy trial (QB46C-H01/2) has been completed in 22 patients. QBiotics currently has two human clinical trials underway in head and neck squamous cell carcinoma (monotherapy QB46C-H03) and unresectable, Stage IIIB to IV M1c melanoma (in combination with Keytruda® NCT04834973).

[1] 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. J. Vet. Inter. Med. 1-15.

References

1. ^{^} https://qbiotics.com (qbiotics.com)