The US Food and Drug Administration (FDA) has approved QBiotics Group’s Investigational New Drug (IND) application to commence the Phase II clinical trial (QB46C-H07) of tigilanol tiglate.
The plant-derived small molecule, tigilanol tiglate targets various solid tumours across multiple species.
The drug is being developed as an intratumoural treatment for solid tumours.
It has a multimodal action that involves injected tumour responses and systemic responses in non-injected tumours.
Tigilanol tiglate is given by injection directly into a solid tumour and the destruction of injected tumours is facilitated through immune-mediated mechanisms, tumour vascular disruption, and tumour cell necrosis.
The open label QB46C-H07 trial has been designed to assess tigilanol tiglate’s efficacy and safety to treat advanced and/or metastatic Soft Tissue Sarcomas (STS) patients of the extremities and body wall.
It will be conducted in the US and will enrol at least 10 subjects with advanced or metastatic STS.
QBiotics managing director and CEO Dr. Victoria Gordon said: “IND approval for our Soft Tissue Sarcoma trial is an important milestone for QBiotics.
“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.”
In the trial, the participants will be given up to five intratumoural tigilanol tiglate treatments, administered four weeks apart.
The degree of tumour ablation in tumours and or tumour segments treated with one or more tigilanol tiglate injections will be evaluated as the primary objective of the trial.
Tigilanol tiglate’s safety and tolerability assessments, and translational research to assess the changes in the tumour microenvironment, immune responses, and tumour recurrence rate after six months following treatment will be the trial’s secondary and exploratory objectives.