First patient treated in QBiotics’ Phase II Clinical Trial treating head and neck cancer with tigilanol tiglate

Brisbane, 29 March 2023

QBiotics Group Limited (QBiotics) is pleased to announce that the first patient has been treated with the Company’s anticancer intratumoural small molecule tigilanol tiglate in a Phase II head and neck cancer clinical trial (QB46C-H08) at The Kinghorn Cancer Centre in Australia. The principal investigator at The Kinghorn Cancer Centre is Associate Professor Richard Gallagher, who also participated in an earlier preliminary Phase I/IIa trial treating head and neck cancer with tigilanol tiglate (QB46C-H03). The multi-centre QB46C-H08 Phase II trial (being undertaken in Australia and the United Kingdom) is an open-label, single-arm study, to assess the efficacy of tigilanol tiglate in up to 37 patients with a broad range of solid tumours of the head and neck region.

Dr Victoria Gordon, CEO and Managing Director of QBiotics, said “Treating the first patient in our efficacy-focused Phase II trial is an important milestone for QBiotics as it builds on our overall development approach for tigilanol tiglate, which is exploring the drug’s potential against a range of tumour types. We are delighted that Associate Professor Gallagher is participating in this second trial for QBiotics at The Kinghorn Cancer Centre. The incidence of head and neck cancer is significant and growing. We are hoping that results from this trial may eventually lead to providing a new solution for patients with this difficult to treat disease.”

In 2020, there were ~932,000 new cases of head and neck cancers diagnosed globally, with incidence growing at~5% per year¹.

FURTHER INFORMATION:
DR VICTORIA GORDON, CEO & MANAGING DIRECTOR, QBIOTICS GROUP
communications@qbiotics.com or

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

ABOUT TRIAL QB46C-H08
QB46C-H08 (Clinical trial registration number: NCT05608876) is a Phase II, open-label clinical trial to evaluate the efficacy and safety of intratumoural tigilanol tiglate in up to 37 patients with head and neck cancer amenable to injection.
Primary objective of the trial is to evaluate tumour ablation (local tumour control) following treatment(s) with intratumoural injections of tigilanol tiglate.
Secondary objectives of the trial are to assess the safety and tolerability of intratumoural injections with tigilanol tiglate; evaluate local disease control by assessing time to local disease recurrence from last treatment; evaluate the tumour recurrence rate at injected tumour sites; and evaluate progression-free survival.
Exploratory objectives of the trial are to assess the impact on quality of life; assess the degree of wound healing after tigilanol tiglate treatment; assess the tumour response based on RECIST v1.1 and itRECIST; assess changes in tumour biomarkers; and assess changes in the tumour microenvironment.

ABOUT QBIOTICS
QBiotics is an unlisted public Australian life sciences company that discovers and develops pharmaceuticals derived from nature to address unmet medical needs in humans and companion animals. Our current clinical focus is on novel treatments for cancer and debilitating chronic wounds.
QBiotics’ lead oncology product, tigilanol tiglate, is a small molecule targeting a range of solid tumours across multiple species. QBiotics’ business model is to develop products that have applications in both veterinary and human markets. Success in the veterinary programme validates QBiotics technology and de-risks human development while having the potential to generate early revenue.
https://qbiotics.com

ABOUT TIGILANOL TIGLATE
Tigilanol tiglate is a small molecule being developed as an intratumoural treatment for solid tumours. Tigilanol tiglate has a multimodal action that involves injected tumour responses as well as specific systemic immune responses². Complete destruction of the injected tumour is mediated via tumour vascular disruption and death of tumour cells by oncosis, leading to the production of tumour-specific T cells and systemic immune-responses². Following tumour destruction, rapid wound healing with good cosmetic outcomes has been shown to ensue.
A veterinary formulation of tigilanol tiglate (STELFONTA^®) is approved by the European Medicines Agency (EMA), Swissmedic, the US Food and Drug Administration – Centre for Veterinary Medicine (FDA - CVM), the United Kingdom Veterinary Medicines Directorate (UKVMD), and the Australian Pesticides Veterinary Medicines Authority (APVMA) to treat canine mast cell tumours. STELFONTA^® is marketed in Europe, the United Kingdom, the USA and Australia by QBiotics’ distribution and marketing partner Virbac, a global animal health company. In a pivotal US veterinary study, a single injection of STELFONTA^® induced a complete response in 75% of canine mast cell tumours, and an 88% complete response with two injections. There was no tumour recurrence in 89% of evaluable cases 12 months post-treatment³.