DIJON, France--(BUSINESS WIRE)--Regulatory News:
ONCODESIGN (Paris:ALONC) (ALONC – FR0011766229), a biopharmaceutical company specializing in precision medicine, is announcing the results of the second stage of its Phase 1 clinical study assessing the first radiotracer resulting from its Nanocyclix® technology.
This Phase 1 clinical study aims to assess the clinical benefit of radiotracer 18F-ODS2004436 in PET imaging1, by determining its sensitivity and specificity in patients suffering from non-small-cell lung cancer.
By targeting a mutation of the EGFR kinase, this radiotracer could be used as a companion biomarker to identify non-small-cell lung cancer patients who are capable of responding to or withstanding EGFR kinase inhibitor treatment, which is currently the standard treatment. Lung cancer is the world’s most common cause of cancer death, with more than 1.6 million deaths per year2.
The current clinical study has three stages. The first involved eight patients with the mutated EGFR target, who received an injection of the radiotracer. The results of that first stage showed sensitivity in line with the study’s objectives. The second stage involved six patients, the last of whom has just been evaluated. These six patients did not have the EGFR mutation, in order to validate the radiotracer’s specificity. The third stage will start in the summer: four new patients with the mutated EGFR target will be injected with the radiotracer. This third stage will have no impact on the outcome of the radiotracer clinical trial but will serve to optimize the clinical protocol in the design of the following clinical phase.
“We are proud to announce the end of this stage, which confirms the radiotracer’s potential in helping clinicians select the right treatment for their non-small-cell lung cancer patients. In addition, the results confirm the ability of our Nanocyclix technology to generate small molecules that are both extremely powerful and selective, which are important properties for therapeutic and diagnostic molecules,” said Philippe Genne, Chairman, CEO and founder of Oncodesign. “We are looking forward to publishing the detailed results of these two stages of this clinical phase at the EANM3 Congress taking place on 13-17 October in Düsseldorf, and to starting to prepare the upcoming phase 3 of this highly innovative program.”
Next financial release: 1st half 2018 revenue, July 24, 2018 (after market close)
About ONCODESIGN: www.oncodesign.com
Founded over 20 years ago by Dr Philippe Genne, the Company’s CEO and Chairman, Oncodesign is a biopharma company dedicated to the precision medicine. With its unique experience acquired by working with more than 600 clients, including the world’s largest pharmaceutical companies, along with its comprehensive technological platform combining state-of-the-art medicinal chemistry, pharmacology, regulated bioanalysis and medical imaging, Oncodesign is able to predict and identify, at a very early stage, each molecule's therapeutic usefulness and potential to become an effective drug. Applied to kinase inhibitors, which represent a market estimated at over $46 billion in 2016 and accounting for almost 25% of the pharmaceutical industry’s R&D expenditure, Oncodesign’s technology has already enabled the targeting of several promising molecules with substantial therapeutic potential, in oncology and elsewhere, along with partnerships with pharmaceutical groups such as Bristol-Myers Squibb and UCB. Oncodesign is based in Dijon, France, in the heart of the town’s university and hospital hub, and within the Paris-Saclay cluster, Oncodesign has 220 employees and subsidiaries in Canada and the USA.
1 Positron-emission tomography, a technique commonly used in
2 INCA, Epidemiology of lung cancer, 2016.
3 Each year, the EANM Congress attracts more than 6,000 researchers to discuss recent advances in nuclear medicine, particularly in the fields of oncology, cardiology and neurology.