Clovis Oncology and Isotopia Announce Lutetium-177 Clinical Supply Agreement

Isotopia to supply its medical radioisotope, lutetium-177, for the clinical development of Clovis Oncology’s targeted radionuclide therapy candidate FAP-2286

Clovis Oncology, Inc. (NASDAQ: CLVS) and Isotopia Molecular Imaging Ltd. today announced the signing of a clinical supply agreement that provides Clovis Oncology with Isotopia’s lutetium-177 (¹⁷⁷Lu) n.c.a. for use in the clinical development of FAP-2286, Clovis’ fibroblast activation protein (FAP)-targeting therapeutic candidate. FAP-2286 is the first peptide-targeted radionuclide therapeutic (PTRT) candidate directed against fibroblast activation protein undergoing clinical testing and is currently being investigated in the Phase 1/2 LuMIERE study for patients with advanced solid tumors. The agreement covers an initial period of two years. Further details of the agreement were not disclosed.

“Clovis Oncology is committed to advancing FAP-2286’s clinical development program and emerging as a leader in targeted radionuclide therapy. A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement further secures our ability to achieve that goal,” said Patrick Mahaffy, President and CEO of Clovis Oncology. “In particular, we value Isotopia’s expertise and global reach as we advance our targeted radionuclide therapy program into the clinic.”

“Over the past four years, Isotopia has strengthened its supply chain to support the growing global demand and need for higher supply security,” said Keren Moshkoviz, Deputy CEO and BD at Isotopia. “We value the importance of FAP targeting agents to address unmet needs for the treatment of a wide range of cancers. The Clovis team have demonstrated a commitment to this effort, sharing the same values as we hold at Isotopia. We look forward to working closely together with Clovis to support its clinical development.”

FAP-2286 is a clinical candidate targeting FAP that is under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent. FAP is highly expressed by cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, but with limited expression in healthy fibroblasts, potentially making it a suitable target across a wide range of tumors. FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach medical radioisotopes, such as lutetium-177 for therapeutic use, or gallium-68 for imaging use.

¹⁷⁷Lu is a beta-emitting radiopharmaceutical precursor with a half-life of 6.7 days. It is used in precision oncology for targeted radionuclide therapy. It has the ability to deliver therapeutically-beneficial radiation precisely to a tumor when bound to disease-specific targeting therapeutics. Isotopia has developed a unique, stable, consistent, and reliable GMP method to produce a highly pure form of ¹⁷⁷Lu. n.c.a. Isotopia’s ¹⁷⁷Lu contains no metastable ¹⁷⁷Lum, eliminating cost intensive clinical waste management.

In June 2022, the first presentation of initial data from the Clovis-sponsored Phase 1/2 LuMIERE study of FAP-2286 in advanced solid tumors took place at SNMMI and the Company plans to present a further interim data update during the EANM Congress in October 2022. The Phase 1 portion of the LuMIERE study (NCT 04939610) is evaluating the safety of the FAP-targeting investigational therapeutic agent and will identify the recommended Phase 2 dose.

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 has been 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.

For more information about FAP-2286, Targeted Radionuclide Therapy (TRT), or Clovis’ TRT development program, CLICK HERE.

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 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; please visit www.clovisoncology.com for more information, including additional office locations in the US and Europe.

About Isotopia

Isotopia Molecular Imaging Ltd. is a dominant ¹⁷⁷Lu supplier, its development team is a multidisciplinary team consisting of nuclear pharmacists, radiochemists, nuclear engineers, and physicists. The experienced Isotopia team, together with its nuclear pharmacy, cyclotron facility, ¹⁷⁷Lu production site and sterile manufacturing plant, are a well-established platform for manufacturing and collaborations. Isotopia creates collaborations between the scientific and medical community to further develop and experiment with new markers for imaging applications and molecular therapy. For more information: www.isotopia.co.il

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, our plans to present interim data on ongoing clinical 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.

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