Clovis Oncology (CLVS) and Isotopia Announce Lutetium-177 Clinical Supply Agreement
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Clovis Oncology, Inc. (NASDAQ: CLVS) and Isotopia Molecular Imaging Ltd. today announced the signing of a clinical supply agreement that provides Clovis Oncology with Isotopia’s lutetium-177 (177Lu) n.c.a. for use in the clinical development of FAP-2286, Clovis’ fibroblast activation protein (FAP)-targeting therapeutic candidate. FAP-2286 is the first peptide-targeted radionuclide therapeutic (PTRT) candidate directed against fibroblast activation protein undergoing clinical testing and is currently being investigated in the Phase 1/2 LuMIERE study for patients with advanced solid tumors. The agreement covers an initial period of two years. Further details of the agreement were not disclosed.
“Clovis Oncology is committed to advancing FAP-2286’s clinical development program and emerging as a leader in targeted radionuclide therapy. A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement further secures our ability to achieve that goal,” said Patrick Mahaffy, President and CEO of Clovis Oncology. “In particular, we value Isotopia’s expertise and global reach as we advance our targeted radionuclide therapy program into the clinic.”
“Over the past four years, Isotopia has strengthened its supply chain to support the growing global demand and need for higher supply security,” said Keren Moshkoviz, Deputy CEO and BD at Isotopia. “We value the importance of FAP targeting agents to address unmet needs for the treatment of a wide range of cancers. The Clovis team have demonstrated a commitment to this effort, sharing the same values as we hold at Isotopia. We look forward to working closely together with Clovis to support its clinical development.”
FAP-2286 is a clinical candidate targeting FAP that is under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent. FAP is highly expressed by cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, but with limited expression in healthy fibroblasts, potentially making it a suitable target across a wide range of tumors. FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach medical radioisotopes, such as lutetium-177 for therapeutic use, or gallium-68 for imaging use.
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. It has the ability to deliver therapeutically-beneficial radiation precisely to a tumor when bound to disease-specific targeting therapeutics. Isotopia has developed a unique, stable, consistent, and reliable GMP method to produce a highly pure form of 177Lu. n.c.a. Isotopia’s 177Lu contains no metastable 177Lum, eliminating cost intensive clinical waste management.
In June 2022, the first presentation of initial data from the Clovis-sponsored Phase 1/2 LuMIERE study of FAP-2286 in advanced solid tumors took place at SNMMI and the Company plans to present a further interim data update during the EANM Congress in October 2022. The Phase 1 portion of the LuMIERE study (NCT 04939610) is evaluating the safety of the FAP-targeting investigational therapeutic agent and will identify the recommended Phase 2 dose.
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