QBiotics Group Limited has been granted approval of its Investigational New Drug (IND) application by the FDA for lead oncology molecule, tigilanol tiglate. The approval enables initiation of a Phase II clinical trial (QB46C-H07) in patients with STS.
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 mechanisms.
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 tumours."
"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 . We hope that through our research, we may be able to bring forward a new therapeutic option."
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