QBiotics opens Phase II clinical trial to investigate the preliminary efficacy of Tigilanol Tiglate in soft tissue sarcoma

Brisbane, 24 April 2023

QBiotics Group Limited (QBiotics) is pleased to announce that its Phase II clinical trial to investigate the preliminary efficacy of its anticancer intratumoural small molecule tigilanol tiglate in patients with soft tissue sarcoma is now open for recruitment. The QB46C‐H07 trial will be conducted 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 soft tissue sarcoma.

Dr Victoria Gordon, CEO and Managing Director of QBiotics, said “The opening of QB46C‐H07, and ahead of schedule, marks a significant milestone for QBiotics that brings the Company a step closer to addressing a major unmet need for patients with soft tissue sarcoma which currently has limited effective treatment options. The trial is being conducted by world‐class clinicians at Memorial Sloan Kettering Cancer Centre and follows on from the US Food and Drug Administration approval of our Investigational New Drug application for tigilanol tiglate in 2022. We look forward to providing further updates as the trial progresses.”

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