QBiotics Group Limited has lodged a prospectus with the Australian Securities and Investments Commission (ASIC) for an offer seeking to raise up to A$40 million from new and existing shareholders, as the company advances its tigilanol tiglate oncology program following encouraging Phase II head and neck cancer results.
The offer has a minimum raising of A$5 million, with full details contained in the prospectus.
The prospectus is subject to a seven-day ASIC exposure period, which may be extended to a maximum of 14 days. QBiotics cannot accept applications during that period and application forms will not be available until it has ended.
The Prospectus is available to be viewed at https://qbiotics.com/investors/investor-information.
Phase II trial delivers 78% tumour response rate
The fundraising comes after QBiotics reported positive final efficacy and safety results from its Phase II QB46C-H08 trial of tigilanol tiglate in patients with head and neck solid malignancies that were refractory to standard-of-care treatment.
Tigilanol tiglate achieved a 78% Objective Response Rate (ORR) in injected tumours based on Best Observed Response, with 14 of 18 evaluable tumours showing either complete or partial ablation.
Six tumours achieved complete ablation, representing a 100% reduction in tumour volume, with none recurring during the period patients remained on study, which extended for up to five months.
At the patient level, 64% of response-evaluable participants, or nine of 14 patients, achieved complete or partial ablation of a treated tumour or tumour segment, meeting the study's primary efficacy endpoint.
All 16 treated patients were included in the safety analysis, with tigilanol tiglate generally well tolerated. Most adverse events were consistent with its expected local mode of action, including pain, swelling and tumour necrosis.
Lead principal investigator Professor Kevin Harrington of the Royal Marsden cancer hospital in London said: "Our early experience with tigilanol tiglate in diverse head and neck cancers, including a number of difficult-to-treat forms of the disease, has been highly encouraging and suggests promising clinical activity. We look forward to further evaluating its role and determining how it can complement existing treatment options for these patients.”
"Following on from our highly positive results in Soft Tissue Sarcoma, these results provide further evidence of tigilanol tiglate's potential to achieve meaningful tumour ablation in solid tumours. An Objective Response Rate of 78% in injected tumours is particularly encouraging in this difficult-to-treat patient population," QBiotics interim CEO and managing director Ebru Davidson said.
Supporting broader oncology development
The QB46C-H08 study forms part of a series of targeted Phase II trials designed to evaluate tigilanol tiglate across multiple solid tumour indications.
QBiotics believes the latest results support continued development of the treatment in head and neck cancer as well as other solid tumours.
Head and neck cancer remains a significant area of unmet medical need, with around 940,000 new cases and 480,000 deaths globally each year. The global market is projected to reach around US$6.3 billion by 2033.
Davidson added: "Head and neck cancer remains a significant area of unmet medical need, and we believe this data further supports the potential of tigilanol tiglate as a novel intratumoural treatment across multiple solid tumour types. Our thanks to all the trial patients for their participation, and also to the trial Investigators and their teams for driving this important study.”
About QBiotics
QBiotics is developing tigilanol tiglate, a novel small-molecule drug discovered by the company, as an intratumoural treatment for solid tumours.
The drug has a multifactorial mode of action designed to induce pyroptosis, or tumour cell death, stimulate a systemic immune response and initiate wound healing at the treatment site.
The latest Phase II data adds to QBiotics' clinical evidence for tigilanol tiglate and supports further investigation of the therapy across a range of solid tumour indications.