First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation

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By: scienterrific | Last updated: 22 August 2018 | In: Breast Cancer, Medical News Asia, Genitourinary Cancer, Lung Cancer, Melanoma & Skin Cancer, Oncology, Immunotherapy, Translational Research

Article Keywords

prostate cancer, BIL06v, Biosceptre, cancer vaccines, nfP2X7, P2X7, TME, NSCLC

CAMBRIDGE, England, Aug. 21, 2018 /PRNewswire/ — Biosceptre has announced the initiation of its Phase 1 clinical study with the peptide vaccine BIL06v in patients with several types of cancer refractory to, or rejecting, standard of care treatment. Although the study is in broad cancer indication, there will be a focus on lung cancer and prostate cancer.

Biosceptre’s BIL06v vaccine is a peptide-protein conjugate and recruits the patient’s immune system to make antibodies specifically targeted at nfP2X₇-expressing cancer cells, resulting in tumour cell death.

The nfP2X₇ is the ‘non-functional’ P2X₇ receptor. The nfP2X₇ receptor has lost the pore functionality (cell death signalling) but remains the ability of ion channel-driven proliferation signalling. Expression of nfP2X₇ plays an important role in the cancer cell’s avoidance of programmed cell death signals in the tumour microenvironment (TME), thus providing prolific and metastatic advantages to cancer cells.

“The relationship between P2X₇ and cancer is a field of increasing research focus at the moment, and Biosceptres’ data supports the therapeutic potential of targeting nfP2X₇ in human cancer in the clinic.”

~Sir Gregory Winter – Chairman Biosceptre

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.

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Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

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