Brisbane, 16 February 2024
QBiotics Group Limited (QBiotics) is pleased to announce that its lead intratumoural oncology asset, tigilanol tiglate, has been awarded Orphan Drug Designation for the treatment of soft tissue sarcoma by the United States Food and Drug Administration (FDA).
Orphan Drug Designation (ODD) is a special status for drugs considered promising potential treatments for patients with rare (‘orphan’) diseases, being less than 200,000 cases per annum in the United States. The designation can provide for a seven-year window of exclusive marketing rights, post-approval, as well as exemption from user fees and eligibility for tax credits for qualified clinical trials. In addition to the financial benefits, it may also potentially shorten clinical development due to closer collaboration with the FDA.
QBiotics’ Executive Director, Strategic Alliances & Investor Relations, Dr Victoria Gordon commented, “Soft tissue sarcomas constitute a rare group of tumours comprising more than 80 subtypes that affect both adults and children. The prognosis of advanced soft tissue sarcoma patients remains unfavourable and new treatments are urgently needed. The FDA Orphan Drug Designation for tigilanol tiglate signals an important milestone for QBiotics, reflecting its recognition by the FDA as a potential new treatment option for this debilitating and life-threatening disease.”
QBiotics’ Phase II clinical trial (QB46C-H07) is being conducted at Memorial Sloan Kettering Cancer Center in New York, USA with Edmund Bartlett, MD as Principal Investigator. The trial is assessing the preliminary efficacy and safety of tigilanol tiglate in patients with a range of advanced and/or metastatic STS.
GlobalData estimates that there were 124,573 new cases of STS globally in 2021, with the incidence growing at 0.54% per year.
FURTHER INFORMATION
DR VICTORIA GORDON, EXECUTIVE DIRECTOR, STRATEGIC ALLIANCES & INVESTOR RELATIONS
communications@qbiotics.com
MEDIA ENQUIRIES
JANE LOWE, IR DEPARTMENT
jane.lowe@irdepartment.com.au +61 411 117 774
ABOUT SOFT TISSUE SARCOMA
GlobalData estimates that there were 124,573 new cases of soft tissue sarcoma globally in 2021, with the incidence growing at 0.54% per year.
The American Cancer Society estimates that in 2024 about 13,590 new soft tissue sarcomas will be diagnosed in the United States.
According to the Cancer Council of Victoria, around 1,600 Australians are diagnosed with a soft tissue sarcoma each year.
ABOUT TRIAL QB46C-H07
QB46C-H07 (Clinical trial registration number NCT05755113) is a pilot Phase II, open label clinical trial to evaluate the preliminary efficacy and safety of intratumoural tigilanol tiglate in patients with a range of advanced and/or metastatic soft tissue sarcoma.
The Primary Endpoint is ablation rate defined as the proportion of patients achieving >30% reduction in tumour volume assessed by ultrasound compared to baseline.
The Secondary Endpoints are incidence of adverse events and serious adverse events, and pharmacokinetics.
Exploratory Endpoints include local rate of recurrence at the injection site at 6 months post initial injection, and assessment of tumour response in biopsy samples. Biopsies are planned at baseline and at 14 days post-injection, and surgical specimens and blood samples will assess changes in tumour biomarkers.
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.
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.
REFERENCES:
Thank you for your interest in our anticancer product tigilanol tiglate. We post details of our clinical trials on clinical trial registries, such as the Australian New Zealand Clinical Trials Registry (ANZCTR) at www.anzctr.org.au.
Please note:
We understand how truly difficult this time is for those affected by cancer, as cancer has touched the lives, either personally or through our loved ones, of many of us at QBiotics. Please be assured that we are one hundred percent committed to develop products as quickly as possible that effectively and safely address challenging conditions.
With warm regards, the QBiotics team.
Thank you for your interest in our veterinary programme.
Tigilanol tiglate, our lead oncology compound has now been commercialised as a veterinary oncology product, STELFONTA®*.
STELFONTA* is approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA), Veterinary Medicines Directorate (VMD), Australian Pesticides and Veterinary Medicine (APVMA) and Swissmedic; making it the first pharmaceutical treatment available for non resectable, non-metastatic mast cell tumours. As STELFONTA is registered as a prescription product, your veterinarian will be able to decide the best treatment for your dog.
We appreciate how distressing a cancer diagnosis for your pet can be, and wish you and your dog the very best during this time.Warmly, the QBiotics team.
* This link will take you to a product site that contains information that may not comply with the Australian regulatory requirements.
At QBiotics we are proud to be a small part of an important movement driving advances in oncology. Our recently registered pharmaceutical to treat canine mast cell tumours, STELFONTA® (tigilanol tiglate), is backed by a rigorous clinical research programme that we are committed to continue, with the aim of improving the health of companion animals. We are excited to launch the QBiotics’ Research Grant, to support veterinary oncologists and those with a special interest in oncology to deepen our collective understanding of the potential to use STELFONTA to treat solid tumours.
Contact Dr Pamela Jones for details pamela.jones@qbiotics.com
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