On May 4, 2022 Cristal Therapeutics, a Dutch pharmaceutical company developing tailored nanomedicines for the treatment of cancer and other diseases with high unmet patient need, reported the publication of the results of the clinical PICCOLO study in the peer-reviewed journal, Advanced Materials1 (Press release, Cristal Therapeutics, MAY 4, 2022, View Source [SID1234614016]).
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This first-of-its-kind study2, part funded by an EU Horizon 2020 and a Health Holland grant, applied radiolabelling and PET-imaging to non-invasively track CriPec nanomedicines in patients with solid tumours over time. The data showed that a diagnostic dose of CriPec nanomedicine radiolabelled with zirconium-89 (89Zr-CPC634) was reliably predictive for the behaviour of a therapeutic dose and provides a powerful tool to non-invasively monitor the biological journey, including tumour uptake. This opens up the potential of using this approach to stratify patients without exposing them to therapeutic dose levels and thus possible side effects.
In the study, undertaken in close collaboration with researchers from Amsterdam University Medical Centre (location VUmc), radiolabelled CriPec was followed by positron emission tomography / computed tomography (PET/CT) imaging in seven patients with solid tumours. A therapeutic dose as well as a diagnostic dose were administered, and pharmacokinetics and tumour uptake were assessed for both. Extended blood residence and substantial tumour uptake were observed and were in fact found to be comparable for both dose levels. These findings are significant as they provide further evidence for the long circulation and substantial tumour uptake of CriPec nanomedicines in patients, as was previously observed in other clinical studies2,3. They further support the potential for superior therapeutic performance of CriPec nanomedicines.
In addition, the ability to monitor CriPec nanoparticles in patients also provides Cristal Therapeutics with detailed information for use in its rational design process to engineer CriPec nanomedicines for superior therapeutic performance and to stratify patients for precision medicine-based approaches.
Dr Cristianne Rijcken, PharmD PhD, founder and CSO of Cristal Therapeutics said:
"Despite the many advances in the nanomedicine field, the heterogeneity of tumours, both inter- and intra-patient, remains a major challenge. The non-invasive, diagnostic approach validated in this unique study provides valuable insight into the behaviour of CriPec nanomedicines and gives Cristal Therapeutics a powerful tool to further enhance the rational design of our nanomedicines with the goal of stratifying patients for safer, more targeted anticancer treatments in the future."
Cristal Therapeutics is progressing a robust pipeline of nanoparticle therapeutic candidates which are rationally designed to target specific tissues, cells and intracellular components throughout the body. Its strategy is to partner its technology platforms and CriPec based therapeutic products to maximise the potential for advancing new medicines in areas of high unmet need.
Representatives from Cristal Therapeutics will be attending the BIO International Convention in San Diego 13-16 June 2022 – please contact [email protected].
About the PICCOLO study
In the PICCOLO clinical study, a docetaxel-entrapping polymeric nanoparticle was radiolabelled with zirconium-89 (89Zr-CPC634) and positron emission tomography / computed tomography (PET/CT) imaging was performed in seven patients with solid tumours of various origins with two different doses of CPC634: an on-treatment (containing 60 mg m-2 docetaxel) and a diagnostic (1-2 mg docetaxel) dose (NCT03712423). Pharmacokinetic half-life for 89Zr-CPC634 was mean 97.0 ±14.4 hours on-treatment, and 62.4 ±12.9 hours for the diagnostic dose (p = 0.003). At these doses accumulation was observed in 46% and 41% of tumour lesions with a median accumulation in positive lesions 96 hours post-injection of 4.94 and 4.45%IA kg-1 (p = 0.91), respectively.