FDA approves registration of STELFONTA®

17 November 2020

STELFONTA (tigilanol tiglate injection) is now approved by the U.S. Food and Drug Administration’s Center for Veterinary Medicine for the treatment of non-metastatic mast cell tumours (MCT) in dogs, making it the first pharmaceutical treatment available for all grades of canine non-metastatic MCT1

  • FDA approval follows the early 2020 marketing authorisation of STELFONTA by the European Medicines Agency, the Veterinary Medicines Directorate in the United Kingdom and Swissmedic, then subsequent sales in all major markets across Europe
  • Approval for STELFONTA is based on a full data package supporting its safety, efficacy and manufacture. This included a QBiotics sponsored, pivotal, multi centre, randomised, blinded and untreated control study in 123 canine patients with MCT where 75% of canine patients achieved complete tumour resolution (‘Complete Response’) after a single treatment of STELFONTA.2
  • STELFONTA will be launched with U.S. veterinary oncologists in the coming months, and then made available to primary care veterinarians from early 2021 via QBiotics’ marketing and distribution partner, the global animal health company Virbac
  • QBiotics is also currently investigating tigilanol tiglate, the active pharmaceutical ingredient in STELFONTA, in a series of human Phase I and II clinical trials targeting solid tumours as both a monotherapy and an immune checkpoint inhibitor combination therapy.

BRISBANE, 17 November 2020. QBiotics Group Limited (QBiotics), a life sciences company developing novel anticancer and wound healing pharmaceuticals, is delighted to announce that the U.S. Food and Drug Administration’s (U.S. FDA) Center for Veterinary Medicine (CVM) has approved its lead veterinary anticancer product, STELFONTA, making it the first FDA approved treatment for all grades of canine non-metastatic mast cell tumours. The news follows approvals for STELFONTA in early 2020 by the European Medicines Agency (EMA), the United Kingdoms’s Veterinary Medicines Directorate (VMD), and Swissmedic, with subsequent sales in all major European markets.

In the United States, STELFONTA (tigilanol tiglate injection) is indicated for the treatment of all non-metastatic cutaneous MCT and non-metastatic subcutaneous MCT, located at or distal to the elbow or the hock in dogs. MCTs are the most frequently diagnosed cancer in dogs, accounting for up to 21% of skin cancer cases3.

Dr Chad Johannes, Assistant Professor of Oncology at Iowa State University, and consultant to QBiotics commented, “STELFONTA brings a novel therapeutic mechanism and intratumoural delivery route to veterinary medicine. The efficacy and durability of response data in dogs with mast cell tumours are very promising. While surgery will remain the mainstay, I do think STELFONTA will reshape how we approach local mast cell tumour control in many ways.”

Dr Victoria Gordon, CEO and Managing Director of QBiotics, said, “FDA approval is a pivotal achievement for both STELFONTA and QBiotics. STELFONTA has the potential to be a category igniter – given it is easy to administer, provides 75% complete tumour resolution after just one injection, and dogs quickly regain pre-treatment quality of life. European sales of STELFONTA have been impressive,and we are excited to be working with Virbac to bring the drug to the US market to help treat the 3 million dogs there that each year are diagnosed with cancer.”

Dr Gordon continued, “this approval also provides strong validation of our highly efficient business model, where veterinary product sales provide repeatable revenue for the company, and the strong veterinary data underpins our human drug development programme. Clinical efficacy and safety responses reported in canine patients are also being mirrored in our human patients. In a Phase I/IIa human safety trial, tigilanol tiglate, the active ingredient in STELFONTA, demonstrated antitumour responses in a range of solid tumours. This included complete responses (where the tumour is completely destroyed) in head and neck squamous cell carcinoma and melanoma. Notably, a maximum tolerated dose was not declared for this study. We are currently investigating the drug’s potential as both a monotherapy and an immune checkpoint inhibitor combination therapy through a series of Phase II clinical trials."

Tigilanol tiglate is a small molecule that largely acts through specific protein kinase C (PKC) activation4, leading to rapid destruction of the tumour mass and the tumour’s blood supply, as well as stimulation of the immune system. Tumour destruction is followed by rapid healing of the site with minimal scarring.

QBiotics and its partner, Virbac, a global animal health company, will first launch STELFONTA to specialist U.S. veterinary oncologists over the coming months, followed by the launch to primary care veterinarians in early 2021.

QBIOTICS GROUP LIMITED – https://qbiotics.com

DR VICTORIA GORDON, CEO & MANAGING DIRECTOR, QBIOTICS GROUP  victoria.gordon@qbiotics.com or + 61 418 453 737

JANE LOWE, IR DEPARTMENT  jane.lowe@irdepartment.com.au or +61 411 117 774


QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing products for human and veterinary markets.

The company’s lead product, tigilanol tiglate, is an 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-dilutive revenues.

https://qbiotics.com   |   https://stelfonta.com

  1. FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs
  2. A Multicenter, Randomized, Sham-controlled, Investigator- and Owner-masked, Pivotal Safety and Efficacy Study of Intratumoural EBC-46 in the Treatment of Canine Cutaneous and Lower Limb Subcutaneous Mast Cell Tumours. QBiotics Group Ltd., Study ID: PN1894. Published as De Ridder et al., 2020. Randomized controlled clinical study evaluating the efficacy and safety of intratumoural treatment of canine mast cell tumours with tigilanol tiglate (EBC-46). J Vet Intern Med. 2020;1–15.
  3. Garrett, LD. 2014. Canine mast cell tumours: diagnosis, treatment, and prognosis. Veterinary Medicine: Research and Reports, Vol 5.
  4. Boyle G et al. 2014. Intra-lesional Injection of the Novel PKC Activator EBC-46 Rapidly Ablates Tumours in Mouse Models, PLOS ONE, Vol 9, Issue 10