QBiotics’ veterinary drug, STELFONTA® label extended, enabling more dogs to receive cancer treatment without surgery in Great Britain

BRISBANE, 5 February 2025

  • The UK Veterinary Medicines Directorate (VMD) approves extended use of QBiotics’ oncology veterinary pharmaceutical, STELFONTA® (tigilanol tiglate).
  • This variation expands the indication beyond the removal of non-surgical mast cell tumours (MCT) to include those for which surgery is not considered the best treatment.
  • QBiotics is working with marketing/distribution partner, a global animal health company, to share this update with veterinarians across Great Britain.

QBiotics Group Limited (QBiotics) is pleased to announce that the UK Veterinary Medicines Directorate (VMD) has approved an extended marketing authorisation for lead veterinary pharmaceutical, STELFONTA® in Great Britain (England, Scotland and Wales). Effective immediately, veterinarians will be able to prescribe STELFONTA® to treat mast cell tumours if they do not consider surgery to be the best option. Previously STELFONTA® was restricted to the treatment of non-resectable mast cell tumours.

More than 20,000 dogs have been treated with STELFONTA® to date across the United States, Australia, the European Union, Switzerland and the United Kingdom. MCTs are the second most frequent cancer diagnosed in dogs and the most common skin cancer, accounting for up to 21% of skin cancer cases1.

Label extension

The approved indication for STELFONTA® in Great Britain now covers:

The treatment of non-metastatic (WHO staging) mast cell tumours that are either non-resectable or those that are resectable but where surgery is not considered the best option, specifically:

  • Cutaneous mast cell tumours (located anywhere on the dog)
  • Subcutaneous mast cell tumours located at or distal to the elbow or the hock.

Tumours must be less than or equal to 8 cm3 in volume and must be accessible to intratumoural injection.

CEO commentary

CEO and Managing Director, Stephen Doyle commented, “We are delighted with the Veterinary Medicines Directorate’s approval to expand STELFONTA®’s indication for Great Britain. This milestone provides veterinarians with greater scope to offer a patient centric approach to cancer treatment. Ultimately more dogs in Great Britain are now eligible to receive STELFONTA®, an effective non-surgical mast cell tumour treatment.

We are working with our marketing and distribution partner, a global animal health company, to share this update with veterinary professionals across Great Britain. This expansion not only strengthens STELFONTA®’s market presence but also aligns with our broader mission to elevate patients’ quality of life worldwide, while treating challenging conditions.

As we continue to advance tigilanol tiglate in Phase II human clinical trials, we remain committed to developing cutting-edge solutions that improve health outcomes for people and animals.”

About STELFONTA®

Approvals for STELFONTA® are based on a QBiotics sponsored, pivotal, US multi-centre, randomised, blinded and untreated controlled study in 123 canine patients with MCT. In that 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).3 An 87% Complete Response was achieved with two injections. There was no tumour recurrence in 89% of evaluable cases 12 months post-treatment.2 

—ends—

FURTHER INFORMATION
STEPHEN DOYLE, CEO & MANAGING DIRECTOR
communications@qbiotics.com

or  

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

 

ABOUT QBIOTICS

QBiotics is an unlisted public Australian life sciences company that specialises in the discovery and development of novel cell signalling small molecules. QBiotics applies phenotypic screening to generate breakthrough innovation in the discovery of first in class solutions to challenging medical conditions. Our current clinical focus is on novel treatments for cancer and debilitating chronic wounds.

QBiotics’ lead oncology drug, tigilanol tiglate is currently in human clinical Phase II trials in Soft Tissue Sarcoma and Head and Neck Cancer. Tigilanol tiglate has received Orphan Drug Designation from the US FDA for the treatment of Soft Tissue Sarcomas. A veterinary formulation of tigilanol tiglate is registered and marketed as an oncology pharmaceutical, under the trade name STELFONTA®, in the USA, Europe, the UK and Australia.

QBiotics’ lead wound healing drug candidate, EBC 1013, is a small molecule targeting a range of wounds including chronic and acute wounds and burns. A first-in-human Phase I clinical development in patients with venous leg ulcers is open for recruitment.

https://qbiotics.com

 

ABOUT TIGILANOL TIGLATE

Tigilanol tiglate is a small molecule being developed as an intratumoral 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.4, 5, 6 Following tumour destruction, rapid wound healing has been shown to ensue.7, 8

Sources:

  1. Garrett, LD. (2014). Canine mast cell tumors: diagnosis, treatment, and prognosis. Veterinary Medicine: Research and Reports, Vol 5. https://doi.org/10.2147/VMRR.S41005
  2. Jones et al.,(2021). Recurrence-free interval 12 months after local treatment of mast cell tumors in dogs using intratumoral injection of tigilanol tiglate. Journal of Veterinary Internal Medicine, 35(1), 451–455. https://doi.org/10.1111/jvim.16018
  3. De Ridder et al., (2021). Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate (EBC-46). Journal of Veterinary Internal Medicine, 35(1), 415–429. https://doi.org/10.1111/jvim.15806.
  4. Boyle et al. (2014). Intra-lesional injection of the novel PKC activator EBC-46 rapidly ablates tumors in mouse models. PLoS ONE, 9(10), 1–12. https://doi.org/10.1371/journal.pone.0108887
  5. Cullen et al. (2021). Activation of PKC supports the anticancer activity of tigilanol tiglate and related epoxytiglianes. Scientific Reports, 11(1), 1–14. https://doi.org/10.1038/s41598-020-80397-9
  6. Cullen et al. (2024). Tigilanol tiglate is an oncolytic small molecule that induces immunogenic cell death and enhances the response of both target and non-injected tumors to immune checkpoint blockade. Journal for ImmunoTherapy of Cancer, 12(4), e006602. https://doi.org/10.1136/jitc-2022-006602
  7. Reddell et al. (2021). Wound formation, wound size and progression of wound healing after intratumoral treatment of mast cell tumors in dogs with tigilanol tiglate. Journal of Veterinary Internal Medicine, Early release 12 January 2021. https://doi.org/10.1111/jvim.16009
  8. Moses et al. (2020). Novel epoxy-tiglianes stimulate skin keratinocyte wound healing responses and re-epithelialization via protein kinase C activation. Biochemical Pharmacology. 178: 114048. https://doi.org/10.1016/j.bcp.2020.114048