Clovis Oncology and Isotopia Announce Lutetium-177 Clinical Supply Agreement

Thursday, September 22, 2022

Clovis Oncology, Inc. and Isotopia Molecular Imaging Ltd. have announced the signing of a clinical supply agreement to provide Clovis Oncology with Isotopia's lutetium-177 (177Lu) n.c.a. for use in the clinical development of FAP-2286, Clovis' therapeutic candidate targeting fibroblast activation protein (FAP). FAP-2286 is the first peptide-targeted radionuclide therapeutic (PTRT) candidate directed against fibroblast activation protein, currently undergoing clinical testing in the Phase 1/2 LuMIERE study for patients with advanced solid tumors. The agreement spans an initial period of two years, with further details remaining undisclosed.

Patrick Mahaffy, President and CEO of Clovis Oncology, emphasized their commitment to advancing the clinical development program of FAP-2286 and establishing themselves as leaders in targeted radionuclide therapy. Mahaffy highlighted the importance of securing a long-term supply of radioisotopes for the program's success and expressed appreciation for Isotopia's expertise and global reach in advancing their targeted radionuclide therapy program.

Keren Moshkoviz, Deputy CEO and BD at Isotopia, acknowledged the growing global demand and the need for higher supply security in the field of radionuclide therapy. Moshkoviz recognized the significance of FAP targeting agents in addressing unmet needs for treating various types of cancers. Isotopia values the commitment demonstrated by the Clovis team and looks forward to working closely with them to support their clinical development efforts.

FAP-2286 is a clinical candidate designed to target FAP as a peptide-targeted radionuclide therapy and imaging agent. FAP is highly expressed in cancer-associated fibroblasts (CAFs) found in most cancer types, making it a potential suitable target across a wide range of tumors. FAP-2286 consists of a targeting peptide that binds to FAP and a site for attaching medical radioisotopes such as lutetium-177 for therapeutic use or gallium-68 for imaging purposes.

177Lu is a beta-emitting radiopharmaceutical precursor with a half-life of 6.7 days. It is used in precision oncology for targeted radionuclide therapy, delivering radiation specifically to tumors when bound to disease-specific targeting therapeutics. Isotopia has developed a stable, consistent, and reliable method to produce a highly pure form of 177Lu. n.c.a. (non-carrier-added), which eliminates the need for costly clinical waste management.

Clovis Oncology previously presented initial data from the Phase 1/2 LuMIERE study of FAP-2286 at the SNMMI conference in June 2022. They plan to provide an interim data update during the EANM Congress in October 2022. The Phase 1 portion of the LuMIERE study (NCT 04939610) focuses on evaluating the safety of the FAP-targeting investigational therapeutic agent and determining the recommended Phase 2 dose.

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