On June 7, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the completion of recruitment for the Phase II investigator initiated diagnostic trial, BOP (NCT05613842)1, evaluating its 64Cu-SAR-Bombesin product in 30 participants with prostate cancer (Press release, Clarity Pharmaceuticals, MAY 26, 2023, View Source [SID1234632553]).
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BOP (Copper-64 SAR Bombesin in Prostate Specific Membrane Antigen (PSMA) negative Prostate Cancer) is a Phase II investigator-initiated trial (IIT) in 30 patients led by Prof Louise Emmett at St Vincent’s Hospital, Sydney. The BOP trial is assessing the safety of 64Cu-SAR-Bombesin as well as looking at the diagnostic potential across two different groups of men:
Participants with biochemical recurrence (BCR) of their prostate cancer who have negative PSMA positron emission tomography (PET) imaging scans or low PSMA expression disease; and
Participants with metastatic castrate resistant prostate cancer (mCRPC) who are not suitable for PSMA therapy.
Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the BOP trial, commented, "We are very excited with the preliminary results we have generated in the BOP trial to date and believe 64Cu SAR-Bombesin has the potential to play an important role in the diagnosis of prostate cancer lesions that cannot be detected with conventional imaging or PSMA-PET agents, such as tumours that are PSMA-negative or have low PSMA expression. The ability to detect and visualise the cancer correctly holds promise of better treatment outcomes for these patients through more appropriate therapeutic regimens. We look forward to continuing our collaboration with Clarity and also exploring therapeutic benefits of the 67Cu SAR-Bombesin agent for this large patient population where, unfortunately, very few treatment options are available at present."
Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The promising data we are generating on our SAR-Bombesin product has already resulted in the improvements to the management of prostate cancer for patients with PSMA-negative lesions or low PSMA expression in their tumours. We envision that SAR-Bombesin will not only be used as a stand-alone product for diagnosing and treating prostate cancer, but also in combination with PSMA agents to identify and treat both PSMA as well as GRPr expressing tumours for the most optimal therapeutic outcome for these patients.
"We thank Prof Emmett and her team at St Vincent’s Hospital for their hard work and dedication to our mutual goal of improving treatment outcomes for people with cancer. We look forward to a comprehensive data analysis from the BOP trial as we progress the development of this exciting theranostic agent in the US. We hope that the clinical benefits, combined with supply and manufacturing advantages of Targeted Copper Theranostics, will ensure that cancer patients can get their critical treatments on time and at a convenient location, representing a next-generation treatment paradigm focused on the needs of patients and their treating staff."
About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)2-6. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide7. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease8.
Approximately 20% of prostate cancers with BCR are PSMA-PET negative9-12. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product could offer valuable imaging and therapeutic options for not only PSMA-negative patients, but also the large number of patients that have the target receptor on their cancers.