Business Wire

Pan-Cancer Analysis Suggests Fibroblast Activation Protein (FAP) is an Attractive Target for Peptide-Targeted Radionuclide Therapy with FAP-2286

Share

Clovis Oncology, Inc. (NASDAQ: CLVS) announced that nonclinical data describing the expression of fibroblast activating protein (FAP) in a variety of solid tumor types will be presented during the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics, taking place October 7-10, 2021. The analysis, conducted with its partner 3B Pharmaceuticals GmbH, measured FAP expression in multiple tumor types using immunohistochemistry (IHC) as well as the correlation between FAP expression by IHC and in vitro binding of FAP-2286, Clovis’ peptide-targeted radionuclide therapy (PTRT) clinical development candidate that targets FAP.

“We believe these findings across multiple solid tumor types demonstrate the importance of FAP as a cancer target and underscore the potential for 177Lu-FAP-2286 to treat patients with FAP-expressing tumors,” said Dr. Thomas Harding, Executive Vice President and Chief Scientific Officer of Clovis Oncology. “These provide additional validation for our ongoing Phase 1/2 LuMIERE clinical trial of FAP-2286, the first peptide-targeted radionuclide therapeutic in clinical development targeting FAP, and support investigation of FAP-2286 in a broad number of cancer indications. This is representative of our commitment to emerge as a leader in targeted radionuclide therapy by developing innovative radiotherapies such as FAP-2286 for patients with hard-to-treat cancers.”

To determine FAP protein expression in different tumor types, a pan-tumor IHC screen was performed that included 360 samples representing 16 different tumor types. For this analysis, high FAP expression was defined as an overall H-score ≥30 in more than 30% of the samples analyzed in a given tumor type. The IHC screen showed high FAP expression in nine of the 16 solid tumor types evaluated, including 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.

The analysis also demonstrated that in most tumor types, FAP expression was predominantly localized to the stroma surrounding the tumor cells within the tumor microenvironment. FAP expression in tumor cells was also observed: in cancers of mesenchymal origin, such as sarcoma and mesothelioma, tumor-cell expression was common, consistent, and strong; in cancers of epithelial origin, tumor-cell FAP expression was rare and, when present, appeared weaker than in the adjacent stroma.

A significant correlation was seen between FAP expression observed by IHC and in vitro FAP-2286 binding as determined by autoradiography, suggesting that FAP is an attractive target for PTRT in a wide array of tumor types.

Following are details of the Clovis-sponsored presentation:

Poster Number: LBA032 - Pan-Cancer Analysis of Fibroblast Activation Protein Alpha (FAP) Expression to Guide Tumor Selection for the Peptide-Targeted Radionuclide Therapy FAP-2286

Lead author: Tanya T. Kwan, PhD

Category: Radiotherapeutics

Date/Time: Thursday, October 7 at 9:00 am ET

The presentation and accompanying poster can also be viewed at: https://clovisoncology.com/pipeline/scientific-presentations/

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

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 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 (NCT04939610). 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 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 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

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

Europe
Jake Davis, +44 (0) 203.946.3538
Jake.Davis@publicisresolute.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

The Spotlight on Iceland’s Capital City Shines Even Brighter With the Arrival of The Reykjavik EDITION21.10.2021 18:30:00 EEST | Press release

A flourishing culinary hotspot with cool cafés, a rollicking nightlife and an epic music scene, the spotlight is shining brightly on Iceland’s hip capital city and, with typical finesse, the arrival of The Reykjavik EDITION further cements EDITION Hotels' uncanny ability to land in just the right place at the right time. “Reykjavik is a really cool, young city -perfect for our brand,” says Ian Schrager, the visionary pioneer of the boutique hotel concept, PUBLIC and EDITION creator. “We think this is Reykjavik’s time and we’re right here at the very heart of it and at the perfect time.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005764/en/ The Reykjavik EDITION (Photo: Business Wire) Opening in preview on November 9th, 2021, The Reykjavik EDITION will set a new standard as the city’s first truly luxury hotel experience, combining the best of the Icelandic capital with the personal, intimate and individual experienc

MediaTek Selected to Power Vewd for Automotive Platform21.10.2021 17:41:00 EEST | Press release

Vewd, the leading provider of OTT software solutions, today announced that MediaTek’s Autus I20 (MT2712) chipset was selected as the first reference platform to power Vewd for Automotive, a white-labeled, cloud-managed content aggregation and monetization solution for in-vehicle infotainment equipment providers and car manufacturers. MediaTek’s customer base, streaming ecosystem partnerships, and strong technical capabilities make it the strongest supplier to meet the needs of car manufacturers. Together, Vewd and MediaTek will target Strategy Analytics’ estimated 70 million connected cars on the road by 2025. Vewd for Automotive solves key rear-seat content challenges facing manufacturers through a turnkey solution ready for deployment. For manufacturers, content in the car represents an increasing consumer demand, along with the demand for connectivity that provides additional after-sale branding and revenue opportunities. By partnering with content providers, manufacturers can enabl

Biognosys to Present Major Scientific and Technological Advances at the ASMS 2021 Mass Spectrometry Conference21.10.2021 17:00:00 EEST | Press release

Biognosys, a leading inventor and developer of mass spectrometry-based proteomics solutions, today announced they will be presenting major scientific and technological advances on their proprietary proteomics research services, software, and kits at the American Society for Mass Spectrometry (ASMS) Annual Conference from October 31st to November 4th in Philadelphia (USA). Biognosys will present a record number of 3 oral presentations, 10 scientific posters, 2 poster collaborations, 1 workshop panel, and 2 Spectronaut™ breakfast seminars. In addition, their team of scientific experts will be present at booth #224 to answer questions and demo software. Further demo sessions will be offered at the Bruker Daltonics booth #719. Collectively, this presence demonstrates Biognosys’ significant contributions to transforming life science and clinical research with next-generation proteomics, particularly in the areas of plasma proteomics, immunopeptidomics, and proteomics data analysis. Lukas Re

SHV Energy Implements Global Remote LPG Tank Monitoring With Sigfox Netherlands’ 0G Network and Reduces Carbon Emissions21.10.2021 17:00:00 EEST | Press release

SHV Energy and Sigfox are rolling out a global LPG tank level monitoring solution. The implementation has started in France, Belgium and Germany and is already generating lower carbon emissions and improved customer satisfaction. Over the next three years, 50,000 units will be rolled out worldwide. Sigfox’s IoT (Internet of Things) asset monitoring capability enables SHV Energy to reduce the cost of tank level monitoring, while increasing efficiency and productivity. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005065/en/ SHV Energy LPG tank (Photo: Sigfox) SHV Energy, a leading global distributor of off-grid energy such as LPG, LNG, biofuels and renewables, with 30 million customers in 25 countries and 16,700 employees, selected to work with Sigfox, a world’s leading IoT communication service provider and 0G network pioneer. SHV Energy set-up a Telemetry Centre of Excellence and used Sigfox’ solutions and partner At

SSZN Selects Newsight's NSI1000 Chip for Its Advanced Industry 4.0 Production Line Sensors21.10.2021 16:50:00 EEST | Press release

Newsight Imaging Ltd., an innovative semiconductor company developing machine vision sensors, spectral vision chips and systems, announces a commercial agreement with SSZN. SSZN is a leader in developing smart industry 4.0 solutions for supporting automated production line supervision. Newsight will provide SSZN with the NSI1000 - its new and advanced sensor chip. The deal follows a successful design-win where SSZN conducted an evaluation using the NSI1000 chip, closely supported by Newsight's engineering teams in Israel and Shenzhen. The first order of 100,000 chips will be supplied in the upcoming months. The NSI1000 CMOS Image sensor chip, launched by Newsight last year, consists of 32 lines of 1024 pixels and it supports multiple modes, such as multi-triangulation for state-of-the-art accuracy and fast operation on production line inspection. The sensor implements Newsight's enhanced Time of Flight (eTOF™) technology for advanced, long-range, and high-resolution 3D depth image capt

Esper and Lenovo Collaborate on Android Device Deployment in Enterprises21.10.2021 16:05:00 EEST | Press release

DevOps for Devices leader Esper and Lenovo™ are teaming up to place Esper software on key models of Lenovo Android tablets and other intelligent business devices. This collaboration allows enterprises that manage large fleets of devices to focus on their critical line-of-business applications, leaving the device infrastructure and management tasks to Lenovo and Esper’s joint solution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005372/en/ Lenovo K10 Tablet (Photo: Business Wire) As the fastest-growing tablet maker (YoY) last quarter1, Lenovo’s expertise in smarter device design, engineering and user experiences combines with Esper’s modern, DevOps-powered device infrastructure software that lets organizations of every size and segment (e.g. healthcare, retail, hospitality), easily set up, manage, better secure, and maintain large fleets of devices on their journey to digital transformation. “With proprietary feature

Finalist Teams Selected in $10M ANA Avatar XPRIZE Competition21.10.2021 16:00:00 EEST | Press release

XPRIZE, the world’s leader in designing and operating incentive competitions to solve humanity’s grand challenges, announced today that 15 teams from 8 countries are advancing to the finals round of the $10M ANA Avatar XPRIZE competition. Sponsored by All Nippon Airways (ANA), Japan’s largest airline, the Avatar XPRIZE is a four-year global competition focused on the development of an avatar system that will deploy a human’s senses, actions, and presence to a remote location in real time, leading to a more connected world. In the future, avatars could help provide critical care and deploy immediate responses in emergency situations, or offer opportunities for exploration and new ways of collaboration, stretching the boundaries of what is possible and maximizing the impact of skill and knowledge sharing. These avatars must demonstrate the ability to execute tasks across a variety of real-world scenarios and convey a sense of presence for both the operator and the recipient in those inte

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom