New Cancer Treatment for Australian Dogs with APVMA Approval of Stelfonta® from Qbiotics

STELFONTA® is indicated for the treatment of non-metastatic (WHO stage), cutaneous (located anywhere on the body, legs or head in dogs), and non-metastatic subcutaneous MCTs located in dogs. or downstream of the elbow or hock in dogs. Tumors can be of any cytological grade, should be less than or equal to 10 cm3 in volume, and must be accessible for intratumoral injection.

CEO and Managing Director of QBiotics, Dr Victoria gordon said, “The 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 flagship molecule is now available to treat cancer in Australian dogs. ”

The approval of STELFONTA® is based on a QBiotics-controlled, pivotal, multicenter, randomized, blinded, untreated study in 123 canine patients with TCM. In this study, a single injection of STELFONTA® induced a 75% complete response (where the tumor is completely destroyed), compared to untreated control dogs (p = 0.001). A complete response of 88% was obtained with two injections. There was no tumor recurrence in 89% of evaluable cases 12 months after treatment.[1]

Australian regulatory approval follows marketing authorization for STELFONTA® by the United States Food and Drug Administration (FDA-CVM), European Medicines Agency (EMA), Veterinary Medicines Directorate (VMD) in the UK 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 phase I and phase II human clinical trials targeting squamous cell carcinoma of the head and neck and melanoma as 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. The results of tigilanol tiglate canine studies have not only supported the registration of a new veterinary anticancer product, they also inform our human clinical program. In addition, revenues from sales of STELFONTA® financially support the development of our human products, ”said Dr. Gordon.

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


QBiotics is an Australian public unlisted life sciences company that discovers, develops and markets novel anticancer and wound healing pharmaceuticals for the human and veterinary markets. Its flagship molecule, tigilanol tiglate, is a small anticancer drug molecule targeting a range of solid tumors across several species. QBiotics’ business model is to develop products that have applications in both the veterinary and human markets. Successful veterinary programs validate QBiotics technology and reduce human development risks, while generating early, undiluted income.


Tigilanol tiglate is a small molecule under development as an intratumoral treatment for solid tumors. It has multimodal action that involves injected tumor responses as well as systemic responses in uninjected tumors. Complete destruction of the injected tumor is mediated by tumor vascular disruption, tumor cell death by oncosis, and immune-mediated mechanisms.1 After destruction of the tumor, it has been shown that rapid healing of the wound ensues. A phase I monotherapy clinical trial with tigilanol tiglate (QB46C-H01 / 2) was performed in 22 patients. QBiotics currently has two ongoing human clinical trials in squamous cell carcinoma of the head and neck (QB46C-H03 monotherapy) and unresectable stage IIIB to IV M1c melanoma (in combination with Keytruda® NCT04834973).

[1] From Ridder et al., (2020). Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cells with tigilanol tiglate. J. Veterinarian. Inter. Med. 1-15.

SOURCE QBiotics Group Limited

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