Biosceptre has initiated its Phase I clinical trial of the peptide vaccine BIL06v, with the first patient treated at the initial trial site on 16th of August 2018. The first patient was recruited at the Sydney Adventist Hospital in Sydney, Australia, under treating physician and Principal Investigator Associate Professor Gavin Marx. Other clinical sites will be added to the trial in the coming months, and competitive recruitment for the minimum 6 month treatment is anticipated to proceed to the full cohort (20-30) within 12 months.
The trial will accept broad cancer indications with primary focus on prostate and lung cancer patients who are refractory to, or have refused, standard of care treatment. Breast, colorectal and other cancer patients will also be accepted.
The trial has been designed by Dr Bob Li, attending oncologist at the Memorial Sloan Kettering Cancer Center in New York. Dr. Li is a recipient of the American Society of Clinical Oncology (ASCO) Young Investigator Award, and the American Association for Cancer Research (AACR) Young Investigator Translational Cancer Research Award.
The trial will be overseen by Biosceptre’s Chief Medical Officer Professor Paul De Souza, who is Foundation Chair of Medical Oncology, School of Medicine, at Western Sydney University, and Honorary Professor of the NHMRC Clinical Trials Centre, University of Sydney.
Biosceptre’s BIL06v therapy is a peptide protein conjugate vaccine, administered in the presence of an adjuvant. Primary endpoints include evaluation of safety and immunogenicity, with secondary endpoints including dose limiting toxicity and/or maximum tolerated dose as well as recommended Phase II dose. Disease control rate at 12 weeks as well as progression free survival will also be examined.
Exploratory endpoints will include quality of life and overall survival, as well as serum tumour biomarkers and cellular immunogenicity. Archived tissue will be screened for expression of the nfP2X7 target.
Biosceptre Acting Chairman Sir Gregory Winter said “The relationship between P2X7 and cancer is a field of increasing research interest, and supports the potential of targeting nfP2X7 in human cancer in the clinic.”
Chief Executive Officer Gavin Currie said “It is a long journey from discovery of a novel target like nfP2X7 in oncology to eventually putting a first-in-class drug into the clinical setting, and I am delighted that all the hard work has come to fruition. We are very optimistic that this trial will meet its primary endpoints, a critical inflection point for value for our shareholders.”
Chief Medical Officer Paul de Souza said “I am delighted that the first patient has been treated on our Phase I trial. I look forward to reviewing the data and to taking BIL06v into further clinical studies”.
Biosceptre is a Cambridge UK headquartered biotechnology company focused on developing next generation cancer treatments targeting nfP2X7. Biosceptre’s product pipeline includes a range of biologic therapeutics to treat a range of cancer types. For more information visit www.biosceptre.com.
Biosceptres’ pipeline, including clinical stage peptide vaccine BIL06v, all target nfP2X7, a “non-functional” form of the P2X7 receptor in which cell death signalling (pore functionality) is absent, but ability to sustain ion channel driven proliferation signalling remains.
Expression of nfP2X7 is important in the avoidance of cell death by cancer cells. The target allows cells to avoid programmed cell death signals in the tumour micro-environment, and provides growth and metastatic advantages to cancer cells.
Biosceptre’s focus is on validation and exploitation of this novel immuno-oncology target by multiple therapeutic modalities including vaccine, antibody, and cell therapy (Car-T).
A paper describing Biosceptres’ recent discoveries of the relationship between nfP2X7 and the tumour microenvironment, and confirming the role of nfP2X7 in cancer cell biology has been published by the journal Oncogene.