Tumors, the first study on a new type of drug conducted in Italy
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Fifteen years ago someone began to bet on a new possible target to be used against cancer: microRNAs. Now that we know their role much better, the results of the first phase 1 clinical study of a microRNA inhibitor in oncology arrive: microRNA-221, well known for promoting the development of tumors. The trial is entirely Italian (and academic), conducted by the University of Magna Graecia (UMG) and by the Renato Dulbecco University Hospital of Catanzaro thanks to funding from the Airc Foundation. The drug being tested is called LNA-i-miR-221 and the data, published on Journal of Hematology & Oncologyindicate that it is ready for the subsequent experimentation phases, 2 and 3.
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How the experimental drug LNA-i-miR-221 was born
MicroRNAs are, as the name suggests, small molecules of RNA that normally regulate the expression of genes. “We started a decade ago with the idea of identifying and correcting the altered regulation of oncogenic (tumor-promoting, ed.) microRNAs,” he explains. Pierfrancesco Tassone, professor of Medical Oncology at the UMG and coordinator of one of the Special Programs approved under the Molecular Clinical Oncology 5 per thousand tender of the AIRC Foundation. His research team – together with Pierosandro Tagliaferri, also professor of Medical Oncology at UMG – identified microRNA-221 as a possible candidate and therefore designed a specific therapeutic agent. “We have gone through all the stages of advanced preclinical development – continues Tassone – following the international and national regulatory procedures for the approval of drugs. We thus obtained a final product ready for experimental clinical use for the first time in humans.” In the oncological field it is therefore a new frontier (there was only one previous clinical study with micro-RNA inhibitors, on people with hepatitis C virus, the researchers say).
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I study
Phase 1 studies represent the first step in the clinical development of a drug: they are conducted on a few patients and are not intended to prove the efficacy of a new drug, but to study its pharmacokinetics and maximum tolerated dose. This first trial on LNA-i-miR-221 involved a total of 19 patients with different types of advanced solid tumors (breast, colorectal, gastric, liver, ovarian, pancreatic, glioblastoma and mesothelioma), enrolled among February 2019 and December 2021. Of these, 17 – 11 women and 6 men, with an average age of over 60 years – were found to be eligible for evaluation, in a median observation period of 56 days. The results demonstrated the safety and biological activity of this first microRNA-221 inhibitor.
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An independent translational research
“It is the realization of an ambitious project – comments Tassone – carried out exclusively with the contribution of AIRC and its supporters, and which testifies to the possibility of completing an independent translational research path starting from an idea and from the laboratory, developing a drug, making it available in pharmaceutical formulation, to get to the treatment of patients. A path that in our country is mainly industrial and rarely academic and independent, especially in the phases of development and characterization of the new drug”. The researchers hope that the study of this first-in-class drug will stimulate the international community to invest human and financial resources in the development of new therapeutic scenarios. “We are proud to have contributed to this important milestone achieved by Professor Pierfrancesco Tassone and his group, which AIRC has been supporting on an ongoing basis for over fifteen years-onclude Federico Caligaris Cappio, Scientific Director of the AIRC Foundation – We are well aware that research cannot be improvised but is built over time with rigor and method. This is why it is essential to be able to offer the best scientists financial stability on long-term projects”.
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