On December 9, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that presentation by Andrew D. Simmons, Ph.D., Clovis’ Senior Vice President, Translational Medicine, at the 3rd Targeted Radiopharmaceuticals Summit being held virtually December 7-9, 2021 (Press release, Clovis Oncology, DEC 9, 2021, View Source [SID1234596657]). Dr. Simmons’ presentation, titled "Innovations in Peptide Targeted Radionuclide Therapies (PTRT) to Target Fibroblast Activation Protein (FAP) in Solid Tumors", reviews the Company’s preclinical data and describes the Phase 1/2 study currently enrolling for its targeted radiotherapy candidate FAP-2286, the first PTRT and imaging agent targeting FAP to enter clinical development and the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program.
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"Clinician enthusiasm for the potential of targeted radiopharmaceuticals, and in particular, FAP as a target, continues to increase, and we are committed to becoming a leader in this emerging field," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to sharing initial data from the ongoing Phase 1 LuMIERE study of our first targeted radiotherapy candidate FAP-2286, anticipated in 2022."
Following Dr. Simmons’ presentation at 9:35am Eastern time, his slide presentation can be found at View Source with other recent Clovis-sponsored presentations, posters and supplemental information. For more information about FAP-2286, targeted radionuclide therapy, or Clovis’ TRT development program, please visit targetedradiotherapy.com.
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. High FAP expression has been shown in pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non-small cell lung, squamous head and neck cancers, and cancers of unknown primary. High FAP expression was 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.
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 (NCT04939610). 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.