On July 24, 2022 QBiotics Group Limited (QBiotics), a life sciences company developing novel small molecule oncology and wound healing pharmaceuticals, reported that it has been granted approval of its Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for lead oncology molecule, tigilanol tiglate (Press release, QBiotics, JUL 24, 2022, View Source [SID1234616891]). The approval enables initiation of a Phase II clinical trial (QB46C-H07) in patients with STS.
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The QB46C-H07 trial will be undertaken in the USA. This is an open label study that will enrol at least 10 patients with advanced or metastatic STS. Patients will receive up to five intratumoural treatments of tigilanol tiglate, administered four weeks apart, to evaluate the drug candidate’s efficacy and safety in the treatment of STS.
Tigilanol tiglate is a plant-derived small molecule, administered by injection directly into a solid tumour. Injected tumours are rapidly destroyed by tumour cell necrosis, tumour vascular disruption, and immune-mediated mechanisms2.
Dr Victoria Gordon, Managing Director and CEO of QBiotics, said "IND approval for our Soft Tissue Sarcoma trial is an important milestone for QBiotics. It is QBiotics’ first FDA IND and the culmination of a very significant body of work by our team. IND approval is underpinned by a robust data package, including data from our first-in-human QBC46-H01 Phase I study, where tigilanol tiglate demonstrated clinically relevant monotherapy activity in 22 patients with a broad range of refractory solid tumours3."
"This STS trial builds on our overall development approach for tigilanol tiglate, which is exploring this drug candidate’s potential as a pan-tumour treatment for a broad range of solid tumours. QBiotics is also undertaking clinical trials in melanoma and head and neck cancer as part of this broad programme. Implementing a clinical trial in a third cancer indication is a strong move for the company."
"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 challenging 4. We hope that through our research, we may be able to bring forward a new therapeutic option."
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
DR VICTORIA GORDON, CEO & MANAGING DIRECTOR, QBIOTICS GROUP
ABOUT TRIAL QB46C-H07
QB46C-H07 is a Phase II, open label clinical trial to evaluate the efficacy and safety of intratumoural tigilanol tiglate in 10 patients with advanced and/or metastatic Soft Tissue Sarcomas of the extremities and body wall.
Primary objective:
Evaluate the degree of tumour ablation in tumours and or tumour segments treated with one or more injections of tigilanol tiglate.
Secondary and exploratory objectives:
Safety and tolerability assessments of tigilanol tiglate, and translational research to evaluate changes in the tumour micro environment, immune responses, and tumour recurrence rate after 6 months following treatment.