On December 18, 2017 ONCODESIGN (Paris:ALONC) (ALONC – FR0011766229), a biopharmaceutical company specializing in precision medicine, and CYCLOPHARMA, a company developing leading molecular imaging solutions, in cooperation with Centre Georges François Leclerc (CGFL), the regional cancer research and treatment center for Burgundy, reported promising results for the Phase 1 study of the first radiotracer 1 to come out of the IMAkinib program (Press release, Oncodesign, DEC 18, 2017, View Source [SID1234522715]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The radiotracer, labelled with radioactive 18F-fluorine, is a molecule generated using Oncodesign’s Nanocyclix technology whose use as a companion biomarker in targeted EGFR inhibitor therapy2 is being assessed in patients with lung tumors.
The current clinical study has as its primary objective the assessment of the clinical advantages of the radiotracer using PET3, by determining its sensitivity and specificity in patients with pulmonary tumors treated with targeted anti-EGFR therapy. It is the product of cooperation between Centre Georges François Leclerc, Cyclopharma and Oncodesign as part of the Dijon-based Pharmimage cluster.
The first stage of the clinical trial, in 8 patients with EGFR mutations, has produced very encouraging results in terms of product safety, dosage and fixing on pulmonary tumors expressing mutated EGFR. These results allow the launch of the second stage of the clinical study, with the inclusion of 6 new patients with non-mutated EGFR receptors. The aim of this second stage is to demonstrate the radiotracer’s specificity.
Full results from the Phase 1 study are expected in the first half of 2018. Positive results would directly allow the design of a Phase 3 clinical study, with the final objective of application for Marketing Authorization.
"Measuring EGFR receptor activity in lung cancer enables early detection of tumor resistance to anti-EGFR therapies, and thus better care for patients," said Philippe Genne, founder, Chairman and CEO of Oncodesign. "In comparison with other types of companion biomarkers, using liquid or solid biopsy techniques, the advantage of a PET-based approach is that it gives clinicians an idea of the heterogeneity of the disease in the whole of the patient’s body. Together with our partners we have been pioneers in this approach."
Activating mutations for EGFR kinase are a cause of non-small cell pulmonary adenocarcinomas, which represent between 10% and 15% of lung cancers in the Caucasian population and between 30% and 50% of those in patients of Asian origin. This type of cancer affects nearly 6,000 patients in France each year, with a projection of 1.3 million patients worldwide by 2022 (up 22% in 10 years). The main treatments for this pathology include tyrosine kinase inhibitors that target EGFR, meaning that the use of a biomarker that can help clinicians in their selection of treatments is a major step forward in precision medicine.