QBiotics receives first registration for tigilanol tiglate with European Medicines Agency approval of STELFONTA®

January 2020

STELFONTA® (tigilanol tiglate) has been approved by the European Medicines Agency (EMA), making it the first pharmaceutical treatment available for all grades of canine non-metastatic mast cell tumours (MCT). The approval marks the first registration of QBiotics' lead compound tigilanol tiglate, which is also under review by the US Food and Drug Administration - Center for Veterinary Medicine (FDA-CVM) and the Australian Pesticides and Veterinary Medicines Authority (APVMA).

The first in-human Clinical Phase I study of intratumoural tigilanol tiglate has been published in The Lancet's EBioMedicine journal

December 2019

An efficacious dose was achieved and a Maximum Tolerated Dose (MTD) was not reached, indicating tigilanol tiglate tolerability in humans. Promising outcomes were attained in patients with a variety of solid tumour types, with a 27% treatment response, including 18% complete response (full tumour destruction). Following these positive results, a Phase I/II trial of tigilanol tiglate in patients with Head and Neck Squamous Cell Carcinoma (HNSCC) is underway, with the first patient successfully dosed.

QBiotics announces first patient dosed in its phase I/II clinical trial of tigilanol tiglate for head and neck cancer

December 2019

First patient successfully dosed in QBiotics' Phase I/II clinical trial of tigilanol tiglate in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). Tigilanol tiglate is a novel, small molecule that is being tested as a single injection treatment for solid tumours. The Phase I/II clinical trial is a dose escalation study in HNSCC patients designed to determine optimal dosage, safety and tumour response. The QBC46-H03 trial is being run in Australia and India.

Dr Susan Foden joined the Board of QBiotics

October 2019

Dr Susan Foden joined the Board of QBiotics as a non-executive director on 14 October 2019.

International Publication - Tigilanol Tiglate Canine Dose Characterisation Study

11 April 2019