Opening of recruitment for a phase II trial in prostate cancer with Cu-64 SAR-Bombesin in the United States

SYDNEY, September 5, 2022 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical-stage radiopharmaceutical company whose mission is to develop next-generation products that improve treatment outcomes for children and adults with cancer , is pleased to announce that the U.S.-based diagnosis 64Cu SAR-Bombesin test (SABER NCT05407311)[1] for patients with PSMA negative prostate cancer is open to recruitment.

SABER (Copper-64 HERR-BisPSMA in Biochemical Reoccurrence of prostate cancer) is a phase II positron emission tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer after definitive treatment. This is a multicenter, single-arm, non-randomized, open-label trial of 64SAR-Bombesin labeled with Cu in 50 participants. The main objectives of the trial are to study the safety and tolerability of the product as well as its ability to correctly detect prostate cancer recurrence.

Doctor Andrei YagaruPrincipal Investigator of the SABER trial, said, “We are very pleased to initiate patient recruitment for the SABER trial, which will explore and validate the clinical benefits associated with the novel agent SAR-Bombesin. We have been studying Bombesin for many years and believe it to be an agent with great diagnostic and therapeutic potential. We hope this trial will inform us about the role of SAR-Bombesin in the diagnosis of disease in patients with of PSMA-negative prostate cancer by imaging patients on the day of injection and approximately 24 hours after injection, with delayed imaging being a new feature enabled by 64Cu. In addition to investigating the clinical benefits of the product, we also look forward to realizing the benefits of centralized manufacturing and on-demand delivery of copper products. These features have the potential to facilitate universal access to SAR-Bombesin and improve accessibility to treatment facilities across the United States.

“We look forward to expanding trial sites and generating data for this next-generation product that could ensure both ease of access and better treatment outcomes for patients with prostate cancer. prostate BCR,” Dr. Iagaru said.

The SABER trial was developed in response to strong demand from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents or conventional imaging (such as CT scan or MRI). It is based on data generated in patients with PSMA-negative prostate cancer at St Vincent’s Hospital imaged under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS).[2] These data demonstrated the potential for diagnostic imaging in PSMA-negative prostate cancer and highlighted the potential utility of the product as a theranostic agent. SABER also builds on a pilot diagnostic trial of SAR-Bombesin in breast cancer patients, the C-BOBCAT trial, which was recently presented at the prestigious 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO).[3]

Executive Chairman of Clarity, Dr. Alan Taylorcommented, “We are excited to begin recruitment for the SABER trial, having only received our Study May Proceed letter from the US Food and Drug Administration (FDA) in June. SABER reinforces our commitment to conduct clinical trials of Clarity for initial approvals in the United States under clinical protocols that have been reviewed by the U.S. FDA Subject to the results of this Phase II trial, we will seek to advance this diagnostic product into Phase III trials in the United States as soon as possible.

“Given the promising data to date indicating the potential diagnostic and therapeutic benefits of SAR-Bombesin, we are committed to continuing to generate product data with the SABER trial which is a rapid successor to the trial initiated by the BOP investigator in PSMA-negative prostate cancer participants who started at St Vincent’s Hospital in sydney earlier this month. In parallel, we are also preparing a submission to the US FDA for an Investigational New Drug (IND) application for a therapeutic clinical trial with the product later this year.

“We look forward to recruiting and imaging participants in the SABER trial and gathering further evidence of the clinical, environmental and logistical benefits of SAR-Bombesin, hoping that it will provide a large patient population with detection and accurate and precise treatment of PSMA-negative prostate cancer,” said Dr. Taylor.

About SAR Bombesin

SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad application against cancer. It targets the gastrin releasing peptide (GRPr) receptor found on cells of a range of cancers including but not limited to prostate, breast and ovarian cancers. GRPr is present in approximately 75-100% of prostate cancers, including prostate cancers that do not express PSMA (PSMA negative)[4-8]. The product uses Clarity’s proprietary Sarcophagin Technology (SAR) which securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, SAR technology prevents copper from leaking into the body. SAR-Bombesin is a copper-targeted theranostic (TCT) that can be used with copper-64 isotopes (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu for therapy).

About prostate cancer

Prostate cancer is the second most commonly diagnosed cancer in men worldwide and the fifth leading cause of cancer death worldwide[9]. The National Cancer Institute estimates that in 2022 there will be 268,490 new cases of prostate cancer in the United States and approximately 34,500 deaths from the disease[10].

About 20% of prostate cancers with BCR are PSMA-PET negative[11-14]. These patients are therefore unlikely to respond to therapeutics targeting PSMA and currently have few treatment options. As the prostate cancer indication is one of the most important in oncology, there is a significant unmet medical need in this segment.

About Clarity Pharmaceuticals

Clarity is a clinical-stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in the field of innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR technology platform for the treatment of cancer in children and adults.

www.claritypharmaceuticals.com

References

1. ClinicalTrials.gov ID: NCT05407311

2. Niketh J, Bao H, Emmett, L. 64Cu-SAR-Bombesin PET-CT for the detection of biochemically recurrent PSMA-PET negative prostate cancer: a case series. ANZUP Annual Scientific Meeting 2022. Abstract Schedule. Flight 18. Number S1. P55.

3.Wong K. 64Cu-SAR-Bombesin PET-CT Imaging in Staging ER+/PR+/HER2- Metastatic Breast Cancer: Safety, Dosimetry, and Feasibility in a Phase I Trial. 2022 ACSO Annual Meeting.

4. Markwalder R, Reubi JC. Gastrin-releasing peptide receptors in the human prostate: relationship to neoplastic transformation. Research against cancer. 1999;59(5):1152-1159.

5. Fleischmann A, Waser B, Reubi JC. High expression of gastrin-releasing peptide receptors in the vascular bed of urinary tract cancers: promising candidates for vascular targeting applications. Cancer of endocrine origin. 2009;16(2):623-633.

6. Ananias HJ, van den Heuvel MC, Helfrich W, de Jong IJ. Expression of gastrin-releasing peptide receptor, prostate stem cell antigen, and prostate-specific membrane antigen in prostate cancer lymph node and bone metastases. Prostate. 2009;69(10):1101-1108.

7. Reubi JC, Wenger S, Schmuckli-Maurer J, Schaer JC, Gugger M. Bombesin receptor subtypes in human cancers: detection with the universal radioligand (125)I-[D-TYR(6), beta-ALA(11), PHE(13), NLE(14)] bombesin(6-14). Clin Cancer Res. 2002;8(4):1139-1146.

8. Sun B, Halmos G, Schally AV, Wang X, Martinez M. Presence of receptors for bombesin/gastrin releasing peptide and mRNA for three receptor subtypes in human prostate cancers. Prostate. 2000;42(4):295-303.

9. World Cancer Statistics 2020: GLOBOCAN estimates of worldwide incidence and mortality for 36 cancers in 185 countries

10. American Cancer Society, Center for Cancer Statistics,

11. Afshar-Oromieh A, Holland-Letz T, Giesel FL, et al. Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: evaluation in 1007 patients. Imaging Eur J Nucl Med Mol. 2017 Aug;44(8):1258-1268.

12. Ferraro DA, Rüschoff JH, Muehlematter UJ, et al. Immunohistochemical PSMA expression profiles of primary prostate cancer tissue are associated with the detection rate of biochemical recurrence with 68Ga-PSMA-11-PET. Theranostics. 2020;10(14):6082-6094.

13. Baratto L, Song H, Duan H, et al. PSMA- and GRPR-targeted PET: results from 50 patients with biochemically recurrent prostate cancer. J Nucl Med. 2021;62(11):1545-1549.

14. Mapelli P, Ghezzo S, Samanes Gajate AM, et al. 68Ga-PSMA and 68Ga-DOTA-RM2 PET/MRI in recurrent prostate cancer: diagnostic performance and association with clinical and histopathological data. Cancers (Basel). 2022;14(2):334.

For more information please contact:

Clarity Pharmaceuticals
Doctor Alan Taylor Catherine Strong
Executive Chairman Investor/Media Relations
[email protected] [email protected]
+61 406 759 268

This announcement has been authorized for publication by the Executive Chairman.

SOURCE Clarity Pharmaceuticals

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