• QBiotics commences the Australian commercial launch of its lead veterinary drug, STELFONTA®, which is approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the treatment of canine non-metastatic mast cell tumours (MCT)
• The Australian launch is a significant milestone – the culmination of over twenty years of research and development that started with the discovery of the active pharmaceutical ingredient (API) tigilanol tiglate in a Queensland tropical rainforest native tree
• The Australian launch follows other major global companion animal markets including the USA, Europe and the United Kingdom
• The first Australian canine patients have been treated with STELFONTA® which is in the process of being made widely available to Australian veterinarians, including oncologists and general practitioners via QBiotics' marketing and distribution partner, Virbac, a global animal health company

BRISBANE, Australia, Dec. 16, 2021 /PRNewswire/ -- QBiotics Group Limited (QBiotics), a life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, is pleased to announce that it has commenced the commercial sale of its lead veterinary pharmaceutical, STELFONTA® in Australia.

Development of STELFONTA® started in the Queensland tropical rainforest, when QBiotics' co-founders Dr Victoria Gordon and Dr Paul Reddell developed EcoLogic™, a highly successful approach to discovering biologically active small molecules from nature. QBiotics focus for discovery is the megadiverse Queensland tropical rainforest. QBiotics has taken STELFONTA from discovery through clinical development, manufacturing, registration and into the market.

Dr Victoria Gordon, Managing Director and CEO of QBiotics, said "After many years of research and development, we are delighted to see the commercial launch of STELFONTA® in Australia. While dogs are already benefiting from STELFONTA® in other leading global markets, given the origins of the molecule and the effort and investment from so many here, there is an enormous sense of pride that comes with having STELFONTA® available in Australia. I sincerely thank all those QBiotics team members, investors and partners, both past and present, who have contributed to the achievement of this substantial milestone."

In conjunction with marketing and distribution partner, Virbac, QBiotics is now in the process of launching STELFONTA® to Australian veterinarians, including oncologists and general practitioners.

Dr Andrew Blum from Palm Beach Veterinary Clinic has already started prescribing STELFONTA® which he says is "straight forward and easy to use". One of his first canine patients, 11-year-old "Boss" previously had a mast cell tumour surgically removed, and Boss' owner Sharon was keen to try an alternative to surgery when another mast cell tumour was diagnosed. Sharon explained that her "experience with STELFONTA was easy and kind to Boss." She added, "Six days after the injection, the tumour had fallen away, and the rapid healing was quite incredible. STELFONTA has been a godsend."

The first sale of STELFONTA® follows the announcement (7 July 2021) that it had achieved approval by the APVMA for the treatment of canine non-metastatic mast cell tumours (MCT). The approval represented Australia's first pharmaceutical treatment available for all grades of canine non-metastatic MCT. MCTs are the second most frequent cancer diagnosed in dogs and the most common skin cancer, accounting for up to 21% of skin cancer cases^[1].

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

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).^[2] An 88% Complete Response was achieved with two injections. There was no tumour recurrence in 89% of evaluable cases 12 months post-treatment.¹ QBiotics is also developing tigilanol tiglate, the API in STELFONTA, for application in humans.  A human clinical Phase I/IIA dose escalation safety trial has been completed in 22 patients with a broad range of refractory solid tumours, where tigilanol tiglate was shown to be well tolerated. Tigilanol tiglate showed an injected tumour response rate of 60% (Complete Response of 20%, Partial Response of 28%, Stable Disease of 12%).^[3]  

Follow on human clinical trials are currently in progress in patients with head and neck cancer or melanoma, while trials in soft tissue sarcoma are in late-stage preparation. Tigilanol tiglate is being studied alone (as a monotherapy), and in combination with Keytruda®, an anti-PD-1 immune check point inhibitor. 

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 drug candidate, 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 helps to de-risks entry into 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 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] Following tumour destruction, rapid wound healing has been shown to ensue.

[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]

[2] 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. Journal of Veterinary Internal Medicine. 1-15.

[3] Panizza, B.J. et al. 2019. Phase I dose escalation study to determine the safety, tolerability, preliminary efficacy and pharmacokinetics of an intratumoural injection of tiglanol tiglate (EBC-46). EBioMedicine, 50: 433-441

[4] Cullen et al. 2021. Activation of PKC supports the anticancer activity of tigilanol tiglate and related epoxytiglianes. Scientific Reports. 11: 207-214; https://doi.org/10.1038/s41598-020-80397-9^[3]

[5] 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^[4]

MEDIA                                  JANE LOWE, IR DEPARTMENTENQUIRIES                          jane.lowe@irdepartment.com.au^[5] or +61 411 117 774

References

1. ^{^} https://qbiotics.com (qbiotics.com)
2. ^{^} https://doi.org/10.2147/VMRR.S41005 (doi.org)
3. ^{^} https://doi.org/10.1038/s41598-020-80397-9 (doi.org)
4. ^{^} https://doi.org/10.1016/j.bcp.2020.114048 (doi.org)
5. ^{^} jane.lowe@irdepartment.com.au (www.prnasia.com)