The Phase I study was designed by Dr Bob Li, attending oncologist at the Memorial Sloan Kettering Cancer Center in New York, and will evaluate the primary endpoints of safety and immunogenicity. The secondary endpoints include the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

Besides the tolerability and safety, the study will investigate efficacy endpoints such as the disease control rate (DCR) at 12 weeks and the progression-free survival (PFS) and the exploratory endpoints quality-of-life (QoL), overall survival (OS), serum tumour biomarkers, and cellular immunogenicity. Archived tissue samples will be collected for screening of nfP2X₇ expression.

"I am delighted that the first patient has been treated on our Phase 1 trial. I look forward to reviewing the data and to taking BIL06v into further clinical studies."

~Paul de Souza -  Chief Medical Officer Biosceptre

The first patient was recruited by Principal Investigator Associate Professor Gavin Marx on August 16th at the Sydney Adventist Hospital in Sydney, Australia. Other clinical sites are gradually added to the trial over the coming months. Recruitment in the study is competitive and the accrual of the full cohort (20-30 subjects) is expected to take 12 months.

Professor Paul De Souza, Biosceptre's Chief Medical Officer, Honorary Professor of the NHMRC Clinical Trials Centre, University of Sydney, and Foundation Chair of Medical Oncology, School of Medicine, at Western Sydney University, will oversee the study. 

Biosceptre is a biotechnology company headquartered in  Cambridge, United Kingdom. Biosceptre is focused on developing next-generation oncology therapeutics targeting nfP2X₇. Its pipeline includes a range of biologic therapeutics aimed at treating a range of cancer types.