ITM and Merck KGaA Sign Research Evaluation and Option Agreement to Develop Folate Receptor Targeted Radionuclide Therapy

The companies to combine their technologies to develop novel theranostic radiopharmaceuticals

Merck KGaA to supply folate derivatives for the preparation of folate-based radiotheranostics

ITM to receive option for worldwide exclusive license for clinical development and commercialization of folate-based radiotheranostics

GARCHING, Germany I September 17, 2018 I Isotopen Technologien München AG (ITM), a group of specialized radiopharmaceutical companies, announced today that it has signed a Research Evaluation and Option Agreement for a worldwide exclusive license with Merck KGaA, Darmstadt, Germany. Merck KGaA is a global leader for the development and manufacturing of active pharmaceutical ingredients with particular expertise related to reduced folates. This partnership with Merck KGaA will allow for a broader application of ITM´s Theranostics platform to include diagnosis and therapy of patients with folate receptor-positive cancers.

The partnership covers the evaluation of Merck KGaA first-in-class folate derivatives as radiolabeled diagnostic and therapeutic agents for the treatment of serious oncological folate receptor-positive diseases. Under the agreement ITM receives an option for a worldwide exclusive license for clinical development and commercialization of radiolabeled folate derivatives, while Merck KGaA will supply folate precursors for radiolabeling.

Folate receptors are known to be overexpressed by several cancer types, such as ovarian, lung, breast and other types of cancers. The restricted expression of folate receptors to only a few sites in normal tissues makes them an attractive diagnostic and therapeutic target. Folate is a B vitamin that is critical to DNA synthesis as well as other essential cell processes. Folate derivatives retain their receptor binding properties when conjugated to pharmaceuticals. They have been proven to be promising compounds for cancer treatment for quite some time and therefore represent an outstanding addition to ITM´s Targeted Radionuclide Therapy pipeline.

In folate receptor targeting, the folate moiety of the folate-based radiopharmaceutical acts as targeting molecule for both diagnosis and therapy. The radiopharmaceutical is injected into the patient´s body, where it binds to the corresponding receptors on the tumor tissue. The radio-conjugate is then absorbed by the tumor cells. For diagnostic application, medical radioisotopes with short half-lives, like Gallium-68, are combined with the targeting molecule. With highly sensitive molecular imaging technologies like PET (Positron Emission Tomography), whole-body diagnostic images are created. For targeted treatment, folate derivatives are complexed with medical radioisotopes with longer half-lives, like ITM´s highly pure no-carrier-added Lutetium-177. The availability of folate receptor-targeted radiopharmaceuticals for both diagnosis and therapy opens up the way for radiotheranostic applications in various indications.

Dr Matthias Joehnck, Head of R&D Actives and Formulation, Merck KGaA, said: “The use of radiolabeled compounds for diagnosis or therapy in medicine is an intensively developing field. We are pleased that our technology will serve to advance a new and promising approach for cancer treatment.”

“We are very delighted to have access to the outstanding technology and expertise of Merck KGaA in the area of pharmaceutical chemistry and manufacturing of folate-based compounds,” Steffen Schuster, Chief Executive Officer of ITM, added, “Merck KGaA has deep expertise in derivatization chemistry of Folic Acid and manufacturing of GMP grade folates. Their expertise, in combination with our innovative platform-technology, will help us to achieve new milestones in Targeted Radionuclide Therapy."


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