Rotterdam, 10th March 2021,
PRECIOUS has successfully recruited the first patient for Phase-1 clinical trials
Despite the delay caused by the ongoing COVID-19 pandemic, we are proud to announce that the Phase 1 clinical study to 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.
One of the main PIs supervising the study, Prof. dr. J. de Vries 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!”
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.
Novel treatment strategies for cancer are highly needed
The PRECIOUS (Scaling-up immunomodulating nanomedicines for multimodal precision cancer immunotherapy) project is working towards establishing a platform for the development of new medicines that contain immunomodulating components acting at multiple levels. ‘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 ‘, says Prof. dr. C. Figdor. Nanoparticles offer the optimal platform for a combinational immunotherapy, as they are able to encapsulate immunomodulators in biodegradable particles. Currently, immunomodulating nanomedicines are not used to their full potential due to is challenging manufacturing requirements. PRECIOUS is developing a manufacturing process at industrial scale for immunomodulating nanomedicines to test the potential of these nanoparticle-based immunotherapies in the clinic. To ensure that these novel treatment strategies will reach patients, the development of a marketing and commercialisation strategy for these novel medicines is an important part of the project. Together, PRECIOUS will realise a major improvement in cancer therapy to provide cancer patients with enhanced quality of life.
About the consortium
The consortium consists of academic experts in the field from 5 leading institutes (RadboudUMC, University of Konstanz, Institute of Macromolecular Chemistry ASCR, University of Oxford and Fondazione IRCCS Istituto Nazionale dei Tumori) with outstanding track records in the fields of immunotherapy, tumour immunology, preclinical drug development and clinical trials. In addition, it includes cutting-edge biotech companies that will enable project results to be translated to the clinic. Evonik Operations GmbH is the lead manufacturer of PLGA-based particles and will bring in invaluable expertise on manufacturing of nanomedicines. iTeos Therapeutics will develop and provide novel immunomodulators that target the tumour micro-environment. iOx Therapeutics and Oncoarendi Therapeutics will contribute their promising, novel immunomodulators (iNKT and ARG inhibitors respectively) to be part of the immunomodulating nanomedicine platform. SMS-oncology will support the clinical development path with their broad knowledge on clinical trial design and implementation. ttopstart, involved in developing the business cases of many leading cancer therapies and diagnostic tests, will be responsible for the business aspects of PRECIOUS by ensuring a strong exploitation strategy and tight project management. The combined expertise will allow the PRECIOUS consortium to truly perform translational research towards benefit of the most important stakeholder, cancer patients in need of novel treatment strategies.