Cyclopharma announces the preclinical validation of the first radiotracer developed as part of the IMAkinib project, prior to human application.
In 2015, Cyclopharma joined the IMAkinib project, which had been initiated in 2009 by Oncodesign. IMAkinib is a strategic industrial innovation program sponsored by BPI France. Dedicated to the development of novel imaging radiotracers for oncology, IMAKinib aims to find diagnostic solutions that will help select treatments best suited to individual patients, and monitor the treatment’s efficacy thereafter. Within the IMAKinib project, radiotracers are expected to be developed up to the end of phase lla.
These radiotracers are molecules generated by Oncodesign’s Nanocyclix technology and labeled with a radioactive fluoride (18F), which are commonly used for Cyclopharma’s own radiotracers’ commercial production. They will be used in conjunction with PET-Scan cameras (Positron Emission Tomography) to produce images of tumors and metastases and identify molecular targets on tumors, or monitor the response to treatment.
The IMAkinib project includes several programs; the most advanced being the development of an EGFR kinase-targeting radiotracer. Mutations activating this kinase are responsible for non-small-cell lung adenocarcinoma, which accounts for 15% of lung cancers and affects, for example, almost 6,000 patients each year in France (epidemiological source : INCA 2012).
The objective of this radiotracer is to measure increased EGFR kinase activity during the development of the tumors, to select the best treatment for each patient, and to detect any resistance as early as possible. GMP production and qualification of the first clinical quality batches have been conducted successfully at the Pharmimage® GIE R&D platform in Dijon, France, which Cyclopharma and Oncodesign are members.
Cyclopharma will join the IMAkinib project, and will be specifically in charge of radiotracers’ clinical development, bringing its know-how in commercial production selling and marketing of radiolabeled molecules used for diagnosis and the monitoring of treatments.
“The personalization of patient care is now a key public health issue, particularly in oncology, in terms of efficacy of therapies as well as control of health costs. In this respect, Cyclopharma develops state-of-the-art molecular imaging solutions, to improve diagnosis and the monitoring of treatments. IMAkinib is a strategic project in this respect as it will help adapting the therapy to each patient”
Bernard Landès, General Manager of Cyclopharma
“The completion of production tests and regulatory toxicology studies on our first radiotracer confirms the capacity of Oncodesign to generate PET tracers based on its Nanocyclix and Pharmimage platforms, and designed to predict the suitability of targeted treatments for individual patients. Cyclopharma joins the project at a key stage, with the upcoming clinical trial on the first radiotracer generated by IMAkinib. Cyclopharma will be a valuable partner, given its expertise in radiochemistry, clinical development, GMP production, and marketing.”
Philippe Genne, founder and CEO of Oncodesign
Download the press release here.