Preliminary data from QBiotics’ Phase IIa clinical trial in Soft Tissue Sarcoma presented at ESMO Congress 2024
BRISBANE, 17 September 2024
- Preliminary data from pilot Phase IIa clinical trial (QB46C-H07) evaluating QBiotics’ small molecule, tigilanol tiglate (TT) in patients with advanced Soft Tissue Sarcoma (STS) presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Spain.
- This preliminary data is highlighting that TT appears safe for patients with STS, with early indications of efficacy.
- Bartlett et al1 noted that the tolerability and activity warrant further investigation of TT in patients with STS either alone or in combination with other agents.
- QBiotics anticipates being able to formally report results from the trial in early CY2025.
QBiotics Group Limited (QBiotics) is pleased to share a copy of the poster presentation providing preliminary data from its pilot Phase IIa clinical trial in STS. The poster was presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Spain by Principal Investigator on the trial, Edmund Bartlett, MD from Memorial Sloan Kettering Cancer Centre (New York, USA).
The trial completed recruitment in June 2024 which followed TT being awarded Orphan Drug Designation for the treatment of STS by the United States Food and Drug Administration (FDA) earlier this year.
Preliminary data highlighted in the poster indicates that TT appears safe for patients with STS, with early signs of efficacy.
Clinicians from the trial believe that the tolerability and activity observed warrant further investigation of TT in patients with STS.
QBiotics anticipates being able to formally report results from the trial in early CY2025.
QBiotics’ CEO, Stephen Doyle commented, “We are highly encouraged by the impressive preliminary data from our pilot Phase IIa clinical trial in Soft Tissue Sarcoma. This data brings us one step closer to delivering a potential new therapeutic for patients facing this group of rare and heterogeneous solid cancers. We are especially grateful to our Principal Investigator, Edmund Bartlett, MD and his team at Memorial Sloan Kettering Cancer Center for leading this groundbreaking work in STS and for presenting the poster.”
There were approximately 128,000 new cases of STS globally in 2023, with the incidence growing at 0.54% per year1.
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 Endpoint is to assess safety and tolerability of tigilanol tiglate by assessing the 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.
- Study authors: Edmund K. Bartlett, Duan G. Li, Shanie Shemla, Charlotte E. Ariyan, Shannan Dickinson, Aimee Crago, George Li, Narasimhan P. Agaram, Sandra D’Angelo, Robert G. Maki, Samuel Singer, William D. Tap, Ciara M. Kelly
- GlobalData®, American Cancer Society, Cancer Australia, Cancer Research UK, Canadian Cancer Society.
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FURTHER INFORMATION
STEPHEN DOYLE, CEO
communications@qbiotics.com or
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. First-in-human Phase I clinical trial in patients with venous leg ulcers is open for recruitment.
