On June 28, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS), reported that Professor Dr. Richard P. Baum and Dr. Harshad R. Kulkarni, in conjunction with 3B Pharmaceuticals (Clovis’ licensing partner and discoverer of FAP-2286), published a retrospective report of their independent experience with FAP-2286 in named-patient use in The Journal of Nuclear Medicine (Press release, Clovis Oncology, JUN 28, 2021, View Source [SID1234584399]). In the first named-patient experience of the investigational compound conducted at Zentralklinik, Bad Berka, Germany, patients were treated with the FAP-targeted radiotherapy FAP-2286 linked to the radionuclide lutetium-177 (177Lu) as a therapeutic agent after prior confirmation of tumor FAP-positivity in patients by PET/CT imaging.

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In this palliative use setting, FAP-2286 was administered on a named-patient basis to 11 patients with progressive and metastatic adenocarcinoma of the pancreas, breast, rectum, and ovary after prior confirmation of FAP expression. According to the authors, administration of 177Lu-FAP-2286 demonstrated high uptake and long retention in primary and metastatic tumor lesions and an acceptable toxicity profile. The report concludes that the data warrant further investigation of 177Lu-FAP-2286 in clinical studies to systematically evaluate its safety and efficacy, and to define the patient population who would benefit most from treatment.

The Clovis Oncology-sponsored Phase 1/2 LuMIERE study of 177Lu-FAP-2286 is evaluating the compound in patients with advanced solid tumors. FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients appropriate for treatment in LuMIERE.

"We believe the early clinical experience from named-patient use validates our plans to further investigate FAP-2286 as a therapeutic and imaging agent across a variety of solid tumor types," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are very pleased to move FAP-2286 into formal clinical development with the recent initiation of the Phase 1/2 LuMIERE study of FAP-2286, a novel peptide-targeted radionuclide therapy in patients with solid tumors."

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). 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. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

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 (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

About the LuMIERE Clinical Study

LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.