Clovis Oncology Submits Investigational New Drug Applications for Novel Peptide-Targeted Radionuclide FAP-2286 for Therapeutic and Imaging Clinical Trial

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the company has completed submission of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for FAP-2286, the lead compound in its peptide-targeted radionuclide therapy (PTRT) development program. Following clearance of the INDs by FDA, Clovis plans to initiate a Phase 1/2 clinical study of lutetium-177 labeled FAP-2286 (¹⁷⁷Lu-FAP-2286) to determine the dose and tolerability of the FAP-targeting therapeutic agent (Phase 1), with expansion cohorts planned in multiple tumor types (Phase 2). FAP-2286 labelled with gallium-68 (⁶⁸Ga-FAP-2286) will be utilized as a diagnostic to identify patients with fibroblast activation protein (FAP)-positive tumors appropriate for treatment with the therapeutic agent.

“Submission of these INDs is a very important milestone in the development of FAP-2286, the first clinical candidate from our PTRT platform,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Targeted radiopharmaceuticals represent an emerging therapeutic class and an area of significant interest to the clinical community, and FAP is considered a target of particular interest given its high, selective expression in multiple solid tumors. We are enthusiastic about the opportunity to become a leader in the rapidly evolving field of PTRT, and the first to begin clinical development of a peptide-targeted radionuclide therapy targeting FAP.”

Fibroblast activation protein (FAP) is a cell-surface protein that is expressed in limited amounts by normal tissues, but highly expressed in cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.^i,ii,iii Preclinical data demonstrate that ¹⁷⁷Lu-FAP-2286 potently and selectively binds FAP on the surface of CAFs and tumor cells to deliver the beta-particle emitting radioisotope ¹⁷⁷Lu, resulting in DNA damage and cell death.^vi,iv Compelling anti-tumor efficacy of ¹⁷⁷Lu-FAP-2286 has been demonstrated in FAP-expressing preclinical tumor models.^v

Following clearance of the INDs by FDA, the Phase 1/2 study LuMIERE is planned to start in the first half of 2021 to determine the dose of ¹⁷⁷Lu-FAP-2286 to be used in Phase 2 development. The FAP-targeting imaging agent, ⁶⁸Ga-FAP-2286, will be used to identify patients with FAP-positive tumors eligible for treatment with ¹⁷⁷Lu-FAP-2286 in the study. Once the Phase 2 dose is determined, expansion cohorts will evaluate ¹⁷⁷Lu-FAP-2286 and ⁶⁸Ga-FAP-2286 in multiple tumor types.