First patient treated in QBiotics' Phase II clinical trial in patients with soft tissue sarcoma

Brisbane, 9 June 2023

QBiotics Group Limited (QBiotics) is pleased to announce that the first patient has been treated in its Phase II clinical trial (QB46C-H07) to investigate the preliminary efficacy of its anticancer intratumoural small molecule, tigilanol tiglate in patients with Soft Tissue Sarcoma (STS). The QB46C‐H07 trial opened for recruitment in late April 2023 at the Memorial Sloan Kettering Cancer Centre in the USA with Dr Edmund Bartlett, MD as Principal Investigator.

The single centre, US‐based trial is an open‐label, single‐arm study to assess the preliminary efficacy and safety of QBiotics’ lead human oncology asset, tigilanol tiglate in 10 patients with advanced and/or metastatic STS.

Dr Victoria Gordon, CEO and Managing Director of QBiotics, said “I am delighted to confirm that the first patient has been treated in our STS Phase II clinical trial. This trial is important to our overall strategy for tigilanol tiglate, where we are exploring the drug’s ability to treat a range of solid tumour types. STS are a group of rare and heterogeneous solid tumours that occur in the soft tissues of the body, such as muscles and nerves,” continued Dr Gordon. “Due to the complexity of this disease, treatment is challenging¹. We hope that through our research, we may be able to bring forward a new therapeutic option for patients suffering with this disease.”

Global Data estimates that there were 124,573 new cases of STS globally in 2021, with the incidence growing at 0.54% per year².

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-H07

QB46C‐H07 (Clinical trial registration number: NCT05755113) is a Phase II, open label clinical trial to evaluate the preliminary efficacy and safety of intratumoural tigilanol tiglate in 10 patients with advanced and/or metastatic soft tissue sarcoma.

The Primary Endpoint is ablation rate defined as the proportion of patients achieving ≥30% reduction in tumour volume assessed by ultrasound compared to baseline.

The Secondary Endpoints are incidence of adverse events and serious adverse events, and pharmacokinetics.

Exploratory Endpoints include local rate of recurrence at the injection site at 6 months post initial injection, and assessment of tumour response in biopsy samples. Biopsies are planned at baseline and at 14 days post‐injection, and surgical specimens and blood samples will assess changes in tumour biomarkers.

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 responses³. 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‐responses³. 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‐treatment⁴.