The Phase 1 clinical study of PRECIOUS will investigate the safety and efficacy of nanovaccines composed of PLGA particles that contain tumour antigen and adjuvant.
This study will be conducted in RUMC with the support of the CRO team from CATO-SMS over a period of 1 year. Being a first-in-human trial, a safety dose-finding pilot cohort of 18 patients in 3 dose level groups of 6 patients will be recruited amongst advance lung-, bladder-, prostate-, and ovarian- cancer patients whose tumours express NY-ESO-1.
PRECIOUS will revolutionise cancer treatment
The PRECIOUS consortium is coordinated by Prof. dr. Carl Figdor, senior professor in Experimental Immunology of the Tumour Immunology Department of the Radboud University Medical Center, the Netherlands. An international multi-disciplinary consortium of 11 partners, in which 5 leading academic institutes, 4 cutting-edge biotech companies and 2 excellent service providers have joined forces to advance the treatment of cancer using an innovative immunotherapeutic nanomedicine, has received an €8.3 million Horizon 2020 grant (grant agreement No 686089). The project kicked off in May 2016 and will last a duration of 60 months.
Enthusiasm about the trial
One of the main PIs supervising the study shares her enthusiasm about the trial and its possible outcomes:
“We are very pleased to be able to start the clinical trial to test the toxicity and tolerability of Precious-01. A very dedicated group of international scientists and GMP experts have made this possible. And now the time has come, the trial is open for inclusion! We hope to be able to present the first results of this innovative approach to cancer soon!”
The PRECIOUS project is working towards establishing a platform for the development of new medicines that contain immunomodulating components acting at multiple levels. Nanoparticles offer the optimal platform for a combinational immunotherapy, as they are able to encapsulate immunomodulators in biodegradable particles.
“These novel medicines will act as a ‘two-sided knife’ by boosting the immune system, and at the same time attacking the immunosuppressive microenvironment that characterises the tumour site”
– PROF. DR. C. FIGDOR – COORDINATOR PRECIOUS CONSORTIUM