Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the initiation of a development, manufacturing, and services agreement with Evergreen Theragnostics to develop actinium-225-labeled-FAP-2286 (²²⁵Ac-FAP-2286). Under the agreement, Clovis and Evergreen intend to develop radiolabeling chemistry and analytical methods for use in potential future pre-clinical and clinical studies.

“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.

About Clovis Oncology

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, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the US and Europe. Please visit www.clovisoncology.com for more information.

About Evergreen Theragnostics, Inc.

Evergreen Theragnostics, established in 2019, is a leading US-based radiopharmaceutical Contract Development and Manufacturing Organization (CDMO). With a state-of-the-art global GMP facility, Evergreen provides highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals, from early development through commercialization. The company was founded by a team that brings a strong track record in theragnostic radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management. For more information, please visit www.evergreentgn.com.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, statements of our intentions and expectations for our development and discovery programs, including the timing and pace of pre-clinical development, plans for clinical development, plans for additional applications of the FAP-2286 peptide, including potential indications, tumor types and combination trials, and regulatory plans with respect to FAP-2286. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in drug discovery and pre-clinical and clinical development, including the outcome of pre-clinical studies and clinical trials, whether initial results, findings or research will support future studies or development, whether future study results will be consistent with previous study findings or other results, including pre-clinical studies, results in named-patient or similar programs or clinical trials, whether additional studies not originally contemplated are determined to be necessary, the timing of initiation, enrollment and completion of planned studies and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission.

ⁱ Khabibullin et al. 2018. Structure and properties of DOTA-Chelated radiopharmaceuticals within the Ac decay pathway. Med. Chem. Commun. 9. 1155.

ⁱⁱ Scheinberg D, McDevit M. 2011. Actinium-225 in targeted alpha-practical therapeutic applications. Curr Radiopharm. 4 (4): 306 – 320.

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