QBiotics Phase IIa clinical trial in Soft Tissue Sarcoma completion of patient recruitment
BRISBANE, 11 June 2024.
QBiotics Group Limited (QBiotics) is pleased to announce that its Phase IIa human clinical trial in Soft Tissue Sarcoma (STS) (QB46C-H07) has completed recruitment with the final patient receiving tigilanol tiglate and completing their 28 day follow up.
The clinical trial is being conducted at Memorial Sloan Kettering Cancer Center in New York, US with Edmund Bartlett, MD as Principal Investigator. The primary endpoint of the trial is the assessment of drug efficacy of tigilanol tiglate in patients with a range of advanced and/or metastatic STS.
The single centre, US‐based trial is an open‐label, single‐arm study, to assess the preliminary efficacy and safety of tigilanol tiglate in 10 patients with advanced and/or metastatic STS.
Completion of trial recruitment follows tigilanol tiglate being awarded Orphan Drug Designation for the treatment of STS by the United States Food and Drug Administration (FDA) earlier this year. There were approximately 128,000 new cases of STS globally in 2023, with the incidence growing at 0.54% per year.1
QBiotics’ Executive Director, Strategic Alliances & Investor Relations, Dr Victoria Gordon commented, “We are very pleased to have completed the recruitment phase of this tigilanol tiglate pilot study for patients with Soft Tissue Sarcoma which represents a key milestone in the Company’s development of its lead oncology asset. I would especially like to acknowledge the support of our Principal Investigators and their teams, as well as, the QBiotics’ clinical team, for their careful planning, oversight and input in reaching this achievement.”
QBiotics hopes to be able to report results of the trial in early Q1 CY2025.
ABOUT TRIAL QB46C-H07
QB46C-H07 (Clinical trial registration number NCT05755113) is a pilot Phase IIa, open label clinical trial to evaluate the preliminary efficacy and safety of intratumoural tigilanol tiglate in patients with a range of advanced and/or metastatic STS.
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 were taken at baseline and at 14 days post-injection, and surgical specimens and blood samples will be used to assess changes in tumour biomarkers.
- GlobalData®, American Cancer Society, Cancer Australia, Cancer Research UK, Canadian Cancer Society.
FURTHER INFORMATION
DR VICTORIA GORDON, EXECUTIVE DIRECTOR, STRATEGIC ALLIANCES & INVESTOR RELATIONS
communications@qbiotics.com
MEDIA ENQUIRIES / NOTES FOR EDITORS
JANE LOWE, IR DEPARTMENT
jane.lowe@irdepartment.com.au +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 a small molecule targeting a range of solid tumours and is currently in human clinical Phase II development. 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. Preparation is in progress for a first-in-human Phase I clinical trial in patients with venous leg ulcers.