QBiotics announces amended human clinical strategy for tigilanol tiglate and Non-executive Director resignation.

14 February 2023

QBiotics Group Limited (QBiotics) announces that following completion of a review of its human clinical oncology programme, the Company has resolved to close its melanoma clinical trials. QBiotics further announces the resignation of Mr. Nicholas Moore as Non-executive Director of the Company.

Amended Human Clinical Strategy for Tigilanol Tiglate

Following announcement of the closure of its clinical trial in melanoma at the Melanoma Institute of Australia on 11 December 2022, QBiotics completed a full review of its human clinical oncology programme. As a result, the Company has resolved to discontinue development in melanoma with tigilanol tiglate, and thus close both melanoma clinical trials at all sites. The Company has identified Head and Neck Cancer and Soft Tissue Sarcoma as the primary preferred indications for demonstrating clinical efficacy of tigilanol tiglate.

The melanoma programme was comprised of two clinical trials: the tigilanol tiglate monotherapy study QB46C-H04, and the tigilanol tiglate pembrolizumab combination study QB46C-H06. Both of these trials will be discontinued.

QBiotics believes that it is in the best interest of the Company to refocus resources on the Head & Neck Cancer Phase II trial (QB46C-H08), being undertaken in the UK and Australia, and which is now open for recruitment, and the Soft Tissue Sarcoma Phase II trial (QB46C-H07) to be undertaken in the USA and due to open by July 2023. In the opinion of the Board and senior management, refocusing the human oncology clinical programme to these two cancer indications not only offers greater potential for recruiting patients in a more timely manner, thus supporting QBiotics to meet its clinical and commercial milestones, but also increases the Company’s cash runway.

In addition to the Phase II monotherapy Head & Neck Cancer trial, QBiotics is in discussions relating to a clinical trial of tigilanol tiglate in combination with the immune check point inhibitor drug pembrolizumab for the treatment of Head & Neck Cancer.

Dr Victoria Gordon, CEO and Managing Director of QBiotics, said “competition for recruiting patients with melanoma for clinical trials in Australia is very high, and is unlikely to improve in the short to medium term. In closing the melanoma trials, we are able to prudently refocus our resources on other solid tumour indications, with greater potential to meet major milestones in a more timely and cost effective manner.”

“We continue to believe in the therapeutic potential of tigilanol tiglate in treating solid tumours and its ability to deliver clinical benefit. This amendment of our clinical strategy will deliver significant cost savings over the next two years and focus our resources in clinical indications that provide greater potential to build value.”

Non-executive Director Resignation

QBiotics also announces that Mr. Nicholas Moore resigned as Non-executive Director on Friday, 10 February 2023 with effect from that day. The Board takes this opportunity to thank Mr. Moore for his commitment and contributions to the Board during his tenure and wishes him the very best in his future endeavours.