Anticancer candidate trialled in solid tumours
Australian life sciences company QBiotics has announced positive results from its first-in-human Phase I clinical trial of its anticancer pharmaceutical, tigilanol tiglate (EBC-46), as published in the journal EBioMedicine.
The key objectives of the Phase I, open-label, single-arm, non-randomised, dose-escalation study were to determine the safety profile, tolerability, pharmacokinetics (PK) and preliminary antitumour efficacy of tigilanol tiglate when administered once by intratumoural injection. The study was conducted in 22 patients, and a range of tumour types, at four hospital sites in Australia.
Tigilanol tiglate was generally well tolerated and doses escalated from 0.06 to 3.6 mg/m, without reaching a maximum tolerated dose. Signs of clinical activity were also observed in all nine tumour types, even at the lowest doses.
“As this was a first-in-human, single-dose safety study, the expectation of a strong anticancer response was low,” said QBiotics CEO and Managing Director Dr Victoria Gordon. “However, the results revealed a 27% treatment response, including an 18% complete response with full tumour destruction across a wide variety of solid tumour types.
“Solid tumours account for up to 80% of all tumour types, so the results from this Phase I study indicate potentially broad applications for tigilanol tiglate in a range of tumours, and an important advancement for our pharmaceutical.
“Additionally, two patients with melanoma demonstrated an anenestic (or abscopal) response, where non-injected tumours at different locations in the body also reduced in size. These results were achieved despite many patients not receiving an optimal dose.”
The vast majority (96%) of adverse events (AEs) were mild to moderate, with the most commonly reported AE being injection site reaction related to the mode of action of tigilanol tiglate. AEs were generally managed with symptomatic therapy.
“Given the very good safety profile, and positive antitumour responses observed, this study supports further development of tigilanol tiglate as a potential treatment of solid tumours,” Dr Gordon said.
Dr Gordon said the results also underpin QBiotics’ recently announced Phase I/II trial of tigilanol tiglate in patients with head and neck squamous cell carcinoma (HNSCC) — a dose escalation study aimed at determining the maximum tolerated dose and recommended dose level for further studies. The open label study will also investigate safety, tolerability and tumour response following single or multiple doses of tigilanol tiglate, and will enrol up to 40 patients from the Tata Medical Centre in Kolkata, the Tata Memorial Hospital in Mumbai and other clinical sites in Australia.
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