Clovis Oncology Highlights Ongoing Phase 1/2 LuMIERE Clinical Study and Multi-Tumor Imaging Investigator-Initiated Trial of FAP-2286 Fibroblast Activation Protein-Targeted Radiotherapy Candidate at an Upcoming Nuclear Medicine Meeting

Rhea-AI Summary

Clovis Oncology (NASDAQ: CLVS) announced the Phase 1 details of the LuMIERE clinical study for its targeted radiotherapy candidate, FAP-2286, at the SNMMI Mid-Winter and ACNM Annual Meeting (Feb. 25-27, 2022). This study aims to evaluate the safety and dosage of lutetium-177-FAP-2286 in approximately 50 patients with advanced solid tumors. The initial results from the trial are anticipated later in the year, indicating potential advancements in targeted radiotherapy for various solid tumors. FAP-2286 is Clovis' first peptide-targeted radionuclide therapy in clinical development.

Positive

• The Phase 1 LuMIERE trial is currently enrolling 50 patients, which can provide crucial safety data for FAP-2286.
• Presentation of initial data from the trial is expected later this year, potentially positioning FAP-2286 as a significant therapy in cancer treatment.

Negative

• None.

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced a Trial-in-Progress poster detailing the Phase 1 portion of the LuMIERE clinical study for its targeted radiotherapy candidate FAP-2286 and a presentation titled “Initial Experience with FAP-2286 Imaging” related to an ongoing investigator-initiated trial (IIT) evaluating the ability of imaging agent gallium-68 (⁶⁸Ga)-FAP-2286 to detect metastatic cancer in patients with solid tumors. These data will be presented by Thomas A. Hope, M.D., Director of Molecular Therapy in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco (UCSF), and principal investigator of the LuMIERE trial and the IIT at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Mid-Winter and American College of Nuclear Medicine (ACNM) Annual Meeting being held virtually, Feb. 25-27, 2022.

FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development and the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program.

Approximately 50 patients will be enrolled in the Phase 1 portion of the multicenter, open-label LuMIERE trial, which is currently enrolling patients with advanced solid tumors (NCT04939610). The Phase 1 portion of the study is evaluating the safety of the investigational therapeutic agent lutetium-177 (¹⁷⁷Lu)-FAP-2286 and will identify the recommended Phase 2 dose and schedule. The safety and tumor uptake of the imaging agent gallium-68 (⁶⁸Ga)-FAP-2286 is also being evaluated. Once the Phase 2 therapeutic dose is determined, Phase 2 expansion cohorts in multiple tumor types are planned for later in 2022.

“We believe the ongoing LuMIERE trial will underscore the valuable role of targeted radiotherapy in cancer treatment and the potential of FAP-2286 to treat a variety of solid tumor types,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We remain committed to advancing targeted radiotherapies in oncology and look forward to presenting initial data from the Phase 1 portion of the trial later this year.”

After 10 a.m. Eastern time today, February 25, the LuMIERE Trial-in-Progress poster can be found at https://clovisoncology.com/pipeline/scientific-presentations/ with other recent Clovis-sponsored presentations, posters, and supplemental information.

Presentation of data from the IIT (NCT04621435) evaluating the ability of imaging agent ⁶⁸Ga-FAP-2286 to detect metastatic cancer in patients with solid tumors is scheduled for Saturday, February 26.

For more information about FAP-2286, targeted radionuclide therapy, or Clovis’ TRT development program, please visit targetedradiotherapy.com.

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. 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.

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 cancer 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 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.

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 and expected timing and pace of clinical development, plans for additional applications of the FAP-2286 peptide, including potential indications, tumor types and combination trials, plans for presentation of data 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220225005066/en/

Clovis Investor Contacts:

Anna Sussman, 303.625.5022

asussman@clovisoncology.com

or

Breanna Burkart, 303.625.5023

bburkart@clovisoncology.com

Clovis Media Contacts:

US

Lisa Guiterman, 301.347.7964

clovismedia@clovisoncology.com

Source: Clovis Oncology, Inc.

FAQ

What is the purpose of the LuMIERE trial for CLVS?

The LuMIERE trial aims to evaluate the safety and optimal dosing of FAP-2286 in patients with advanced solid tumors.

When will data from the Phase 1 LuMIERE trial be available for CLVS?

Initial data from the Phase 1 portion of the LuMIERE trial is expected to be presented later in 2022.

How many patients are being enrolled in the LuMIERE trial?

Approximately 50 patients will be enrolled in the Phase 1 portion of the LuMIERE trial.

What is FAP-2286 and its significance for CLVS?

FAP-2286 is a peptide-targeted radionuclide therapy candidate that targets fibroblast activation protein, marking Clovis Oncology's first entry into this innovative treatment approach.

What is the expected outcome of the LuMIERE trial for CLVS?

The trial is expected to underscore the role of targeted radiotherapy in treating various solid tumors and lead to potential Phase 2 expansion cohorts.