On March 16, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the initiation of a development, manufacturing, and services agreement with Evergreen Theragnostics to develop actinium-225-labeled-FAP-2286 (225Ac-FAP-2286) (Press release, Clovis Oncology, MAR 16, 2022, View Source [SID1234610168]). Under the agreement, Clovis and Evergreen intend to develop radiolabeling chemistry and analytical methods for use in potential future pre-clinical and clinical studies.
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"This agreement with Evergreen Theragnostics represents an important step forward for Clovis in our efforts to optimize our clinical development program for FAP-2286," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are enthusiastic about exploring the potential of FAP-2286 labeled with actinium-225 in our targeted radiopharmaceuticals program. Actinium-225 represents an emerging radionuclide that is generating significant interest for its potential for therapeutic use."
Actinium-225 (225Ac) is an alpha particle-emitting radionuclide uniquely suited to targeted radiotherapeutic applications based on its half-life of approximately 10 days, balancing the ability to deliver a meaningful dose of radiation to target tumors while allowing central manufacturing and distribution of 225Ac-FAP-2286. The high-energy radioactive decay emitted from tumor-targeted 225Ac delivery causes double-stranded DNA damage and cell death, however, given the limited distance traveled by alpha particles, damage is minimized to cells in the tumor mass and systemic toxicity is potentially limited. i,ii
Under the terms of the agreement, Evergreen will develop 225Ac-FAP-2286 at its facility in Springfield, N.J. The facility was purpose-built to develop and manufacture a variety of therapeutic radiopharmaceuticals, including those based on alpha-emitting isotopes such as 225Ac, from early development to commercial scale manufacturing.
"We are excited to support Clovis and its targeted radionuclide development program with the development of an actinium-225-labeled FAP-2286. Actinium-based radiotherapies offer the potential to play an important role in the fight against cancer," said James Cook, CEO of Evergreen Theragnostics. "We seek to provide a robust and efficient radiopharmaceutical manufacture, testing, and supply process for our partners from early-stage development through commercialization."
FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development. In the Phase 1/2 LuMIERE study (NCT04939610), the investigational therapeutic agent is linked to lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). Lutetium-177 (177Lu) is a beta-particle-emitting radionuclide with established supply and distribution networks ideally suited for clinical development of a PTRT. FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) is being used as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. FAP-2286 is the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program.
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, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. 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.