Cambridge technology targeting killer cancers enters key trials
Cambridge life science innovator Biosceptre has announced trials of a peptide vaccine that offers hope to patients suffering some of the most lethal types of cancer.
The Phase 1 clinical trial has been designed by a leading oncologist in New York and the first patient has already been enrolled – in Australia.
Now Babraham-based Biosceptre – chaired by life science entrepreneur Sir Greg Winter (pictured) – is stepping up the enrolment process to accelerate progress through the key trial stages. As well as its state-of-the-art Cambridge UK facilities, the company has a similar flagship in Sydney.
The Phase 1 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 peptide vaccine is branded BIL06v and the first patient was recruited at the Sydney Adventist Hospital under treating physician and Principal Investigator Associate Professor Gavin Marx.
Other clinical sites will be added in the coming months and competitive recruitment for the minimum six-month treatment is anticipated to proceed to the full cohort of 20-30 patients within 12 months.
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 Young Investigator Award and the American Association for Cancer Research 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 Greg 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.”
CEO Gavin Currie added: “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.”