QBiotics’ tigilanol tiglate meets Primary Endpoints in its Phase I/IIa head and neck cancer dose escalation trial

Brisbane, 16 August 2023

• QBiotics reports that Primary Endpoint of safety and tolerability were met in its Human Clinical Phase I/IIa
  dose escalation safety trial of tigilanol tiglate conducted as a window of opportunity before surgery study
  in 19 patients with head and neck squamous cell carcinoma (QB46C-H03).
• Tigilanol tiglate treatment was well tolerated at all dose levels. The drug successfully escalated to a dose
  of 2.4 mg/m2 without any Serious Adverse Events (SAEs) other than an extension of an overnight stay for
  one patient; Adverse Events (AEs) reported were local, expected and associated with the mode of action
  (MOA) of the drug.
• Rapid induction of haemorrhagic necrosis was evident within hours in all injected tumours at all dose
  levels with no necrosis reported in the surrounding normal tissue.
• Translational research findings from assessment of tumour biopsy samples were consistent with induction
  of immunogenic cell death and stimulation of a localised immune response, supporting the MOA of the
  drug proposed from previous studies in animal models.

QBiotics Group Limited (QBiotics) is pleased to report that its QB46C-H03 Human Clinical Phase I/IIa dose
escalation safety trial of its anticancer drug, tigilanol tiglate, in patients with head and neck squamous cell
carcinoma (HNSCC), achieved its Primary Endpoint of safety and tolerability when administered as a single
intratumoural dose.

Nineteen patients were treated in a window of opportunity before surgery study at multiple sites in India and
Australia. Tigilanol tiglate successfully escalated to a dose of 2.4 mg/m2 without any Serious Adverse Events
(SAEs) other than an extension of an overnight stay for one patient. Adverse Events (AEs) reported were all
local and, other than pain, were associated with the mode of action (MOA) of the drug in tumour destruction.
QBiotics decided to end the trial on the basis it had sufficient safety information to inform the Company’s
subsequent Human Clinical Phase II efficacy trial in head and neck cancer which is now open at multiple sites
in Australia and the UK.

Overall, tigilanol tiglate injections were well tolerated at all dose levels administered in the QB46C-H03 trial.
Rapid, drug-induced haemorrhagic necrosis was evident in all injected tumours at all dose levels, with no
necrosis of surrounding normal tissue reported for any patient.

Translational research results from assessment of biopsy samples taken from injected tumours within the first
hours following treatment demonstrated the rapid induction of markers of immunogenic cell death, while
untreated areas of tumour that were surgically excised between 15 to 21 days later showed a consistent
increase in immune cell infiltrate compared to pre-dose samples. This data supports the proposed MOA of
the drug in humans and is consistent with that observed in animal models and inferred from laboratory data.

QBiotics’ CEO and Managing Director, Dr Victoria Gordon commented, “We are very pleased with the results
of this trial in patients with HNSCC which provides increased confidence in the safety and tolerability of
tigilanol tiglate and expands our understanding of the immune-stimulating mode of action of the drug.”

“Surgery and radiotherapy are currently the mainstay for patients with HNSCC, however these treatment
approaches are frequently anatomically difficult and often result in significant disfigurement. We see potential for tigilanol tiglate, alone or in combination with other modalities, to offer an effective future treatment option
for HNSCC tumours with good clinical and cosmetic outcome for patients.”

FURTHER INFORMATION
DR VICTORIA GORDON, CEO & MANAGING DIRECTOR, QBIOTICS GROUP
communications@qbiotics.com 

MEDIA ENQUIRIES
JANE LOWE, IR DEPARTMENT
jane.lowe@irdepartment.com.au  +61 411 117 774

ABOUT QBIOTICS

QBiotics is an unlisted public Australian life sciences company that discovers and develops pharmaceuticals derived from nature to address unmet medical needs in humans and companion animals. Our current clinical focus is on novel treatments for cancer and chronic wounds.

QBiotics’ business model is to develop products that have applications in both veterinary and human markets. Success in the veterinary programme validates QBiotics technology and de-risks early stages of human development while having the potential to generate early revenue.

QBiotics’ lead oncology product, tigilanol tiglate, is a small molecule targeting a range of solid tumours and is currently in two human clinical Phase II trials treating (i) head and neck cancer, and (ii) soft tissue sarcoma. A veterinary formulation of tigilanol tiglate is registered and marketed as an oncology pharmaceutical, under the trade name STELFONTA^®, in the USA, Europe, the UK and Australia.

QBiotics’ lead wound healing product is a small molecule targeting a range of wounds including chronic and infected wounds and burns. Preparation is in progress for a first-in-human Phase I/IIa clinical trial in patients with venous leg ulcers.

https://qbiotics.com

ABOUT TIGILANOL TIGLATE

Tigilanol tiglate is a novel, small molecule drug discovered, and in development, by QBiotics as an intratumoural treatment for solid tumours. Tigilanol tiglate has a multifactorial mode of action that induces tumour cell death by oncosis, stimulates an immune response¹ and initiates wound healing at the treatment site resulting in good functional and cosmetic outcomes.