Policy & Regulation
Clovis Oncology, Isotopia Ink Lutetium-177 Clinical Supply Agreement
23 September 2022 - - US-based biopharmaceutical company Clovis Oncology, Inc. (NASDAQ: CLVS) and Israel-based Isotopia Molecular Imaging Ltd. have signed 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 -targeting therapeutic candidate, the companies said.

FAP-2286 is the first peptide-targeted radionuclide therapeutic 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.

FAP-2286 is a clinical candidate targeting FAP that is under investigation as a peptide-targeted radionuclide therapy and imaging agent.

FAP is highly expressed by cancer-associated fibroblasts 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.

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy and imaging agent targeting fibroblast activation protein.

FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use.

High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers.

High FAP expression has been detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue.

Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment.

Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer.

Agents that can be adapted for both therapeutic and imaging use are known as "theranostics."

Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic and imaging agent, as well as three additional discovery-stage compounds.

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the US, Europe, and additional international markets.

Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops with partners diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use.

Isotopia Molecular Imaging Ltd. is a dominant 177Lu supplier, its development team is a multidisciplinary team consisting of nuclear pharmacists, radiochemists, nuclear engineers, and physicists.