Blue Earth Diagnostics Announces Findings on Clinical Factors Impacting Detection Rates from SPOTLIGHT Phase 3 Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Prostate Cancer Recurrence

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− Highlighted oral presentation at the American Society for Radiation Oncology (ASTRO) 2022 Annual Meeting –

MONROE TOWNSHIP, NJ & OXFORD, England, October 24, 2022–(BUSINESS WIRE)–Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative radiopharmaceuticals for PET, today announced the results of its Phase 3 SPOTLIGHT trial which assessed the impact of various clinical factors, including baseline levels of prostate-specific antigen (PSA), PSA doubling time, and Gleason score, on detection rates (DR) for 18F-rhPSMA-7.3 in recurrent prostate cancer. 18F-rhPSMA-7.3 is an investigational high-affinity radiohybrid (rh) PET imaging agent targeted to prostate-specific membrane antigen. The findings were reported in an oral presentation at the American Society for Radiation Oncology (ASTRO) 2022 Annual Meeting in San Antonio, Texas.

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18F-rhPSMA-7.3 PET image showing the spread of prostate cancer beyond the prostate region (Photo courtesy of Blue Earth Diagnostics)

“The ability to determine the extent and location of recurrent prostate cancer to inform the appropriate clinical management of these men is critical for physicians and their patients, as up to 40% of patients who undergo prostatectomy radical and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years,” said Benjamin Lowentritt, MD, Chesapeake Urology Research Associates, Towson, Md., on behalf of the study group. SPOTLIGHT.” An increase in PSA after radical prostatectomy usually precedes a clinically detectable recurrence by several years, but does not differentiate local, regional, or systemic disease. The usefulness of conventional imaging for locating recurrence is limited, particularly in patients with low PSA levels. Relapse after curative intent, primary treatment remains a considerable clinical burden, and accurate imaging techniques are needed to identify areas of involvement to facilitate the delivery of optimized patient care. 18F-rhPSMA-7.3 PET over a wide range of baseline PSA levels.”

“These results from the SPOTLIGHT Phase 3 trial in biochemically recurrent prostate cancer are included in our New Drug Application for 18F-rhPSMA-7.3 PET imaging is currently under review by the U.S. Food and Drug Administration, and we are excited to have them introduced to the radiation oncology community at ASTRO 2022,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “In line with our mission to help cancer patients across the continuum of care, Blue Earth Diagnostics continues to develop our comprehensive prostate cancer portfolio, which includes 18F-fluciclovine and experimental rhPSMA compounds for potential use in diagnostic PET imaging and targeted radiopharmaceutical therapy. 18F-rhPSMA-7.3 represents a new class of PSMA-targeted PET radiopharmaceuticals, with preliminary studies 18F‐rhPSMA‐7.3 showing high binding affinity for PSMA, along with biodistribution data suggesting the potential for low bladder activity.

Results presented at ASTRO included analyzes of clinical factors affecting DR for 18F-rhPSMA-7.3 assessed by three central blinded readers: DR, including region-level analyses, stratified by baseline PSA levels, PSA doubling time, Gleason score, and prior treatment ( radical prostatectomy with or without radiotherapy, or radiotherapy alone). For example, results showed that among 389 patients in the PET-evaluable population, patient-level DR of 18F-rhPSMA-7.3 PET by majority read was 83% (322/389). When stratified by PSA level, the DRs were: PSA 18F-rhPSMA-7.3 PET in the SPOTLIGHT study. Overall, 16 patients (4.1%) experienced at least one treatment-related adverse event that was considered possibly related/related to 18F-rhPSMA-7.3. The most frequently reported events were: hypertension: 1.8% (n=7); diarrhea: 1.0% (n=4); injection site reaction: 0.5% (n=2) and headache: 0.5% (n=2).

The SPOTLIGHT test (NCT04186845) is a Phase 3, multicenter, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence due to elevated PSA after prior treatment. Main results for 18F-rhPSMA-7.3 PET have already been presented at ASCO GU in February 2022,1 with additional results announced at AAU in April 20222 and at SNMMI in June 2022.3

The results were discussed in an oral presentation at ASTRO 2022 on October 24, 2022, “Impact of Clinical Factors on 18F-rhPSMA-7.3 Detection Rates in Men With Recurrent Prostate Cancer: Results from the Phase 3 SPOTLIGHT Study, by Benjamin Lowentritt, MD, Chesapeake Urology Research Associates, Towson, Md., at SPOTLIGHT study group name Full session details and summary are available in the ASTRO online program HERE.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid (“rh”) receptor ligand targeted to the prostate-specific membrane antigen that attaches to and is internalized by prostate cancer cells and can be radiolabeled with 18F for PET imaging, or with isotopes such as 177Read or 225Ac for therapeutic use – creating true theranostic technology. They could play an important role in patient care in the future and offer the potential for precision medicine for men with prostate cancer. The hybrid radio technology and rhPSMA originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to the rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET Imaging in Prostate Cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease and (“PHARE”, NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging SpA, is a growing international molecular imaging company focused on providing innovative and well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the company’s success is driven by management expertise and backed by a proven track record of rapid development and commercialization of Positron Emission Tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

About Bracco Imaging

Bracco Imaging SpA, part of the Bracco Group, is one of the world’s leading providers of diagnostic imaging. Based in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a portfolio of products and solutions for all major diagnostic imaging modalities: X-ray imaging (including computed tomography-CT, interventional radiology and cardiac catheterization), magnetic resonance imaging (MRI), ultrasound contrast enhanced (CEUS) and nuclear medicine. through radioactive tracers and novel PET imaging agents to inform clinical management and guide cancer patient care in areas of unmet medical need. Our ever-growing portfolio is complemented by a range of medical devices, advanced delivery systems and dose management software. In 2019, Bracco Imaging enriched its product portfolio by expanding the range of nuclear imaging solutions in oncology in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging created Blue Earth Therapeutics as a distinct cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.

1DM Schuster, SPOTLIGHT study group. J. Clin. Onc. 2022; 40 (6_suppl):9-9.

2MT Fleming, SPOTLIGHT Study Group, J.Urol. 2022, 207 (5_suppl):31047.

3Kuo, P, SPOTLIGHT study group, J. Nucl. Med. 2022, 63 (2_suppl): 2539.

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contacts

For Blue Earth Diagnostics (USA)
Priscilla Harlan
Vice President, Corporate Communications
(M) (781) 799-7917
[email protected]

For Blue Earth Diagnostics (UK)
Claire Gidley
Marketing and Communication Associate Director
Tel: +44 (0) 7917 536939
[email protected]

Media
Sam Brown Inc.
Mike Beyer
(M) (312) 961-2502
[email protected]

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