On November 21, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (US FDA) to evaluate its SAR-Bombesin product for identification and treatment of metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Clarity Pharmaceuticals, NOV 21, 2022, View Source [SID1234624260]).
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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "This trial with SAR-Bombesin marks our third therapy program, and sixth program overall, in the Targeted Copper Theranostic pipeline that is progressing through clinical trials in the US. Receiving clearance from the FDA is yet another significant milestone for the Company as it continues to showcase the capabilities of Clarity’s small but high performing team in developing next-generation theranostics from the benchtop, through preclinical studies and into clinical trials in the largest pharmaceutical market in the world. This is Clarity’s fifth IND, highlighting our strategy of developing radiopharmaceuticals for the very large US market."
This IND gives Clarity clearance to proceed with a US-based Phase I/IIa 64Cu/67Cu SAR-Bombesin theranostic trial for identification and treatment of mCRPC that is expressing the Gastrin-Releasing Peptide receptor (GRPr).
COMBAT (Copper-67 SAR Bombesin in metastatic castrate resistant prostate cancer) is a dose escalation study with a cohort expansion. The aim for the study is to determine the safety and efficacy of 67Cu-SAR-Bombesin in participants with GRPr-expressing mCRPC in patients who are ineligible for therapy with 177Lu-PSMA-617.
Approximately 25% of mCRPC patients have low or no uptake of a PSMA-targeting tracer.1 These patients are therefore unlikely to show uptake of PSMA-targeted products, such as 68Ga-PSMA-11 for imaging or 177Lu-PSMA-617 for therapy, and currently have few radiopharmaceutical treatment options available to them. Given prostate cancer is one of the largest indications in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product targets the GRP receptor found on prostate and many other cancers. As such, the SAR-Bombesin 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.
Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We look forward to further progressing the development of SAR-Bombesin as a theranostic under this trial, as well as a stand-alone diagnostic agent under the SABRE and BOP clinical trials that are currently progressing in the US and Australia respectively. The diagnostic SAR-Bombesin product has already shown utility in improving the management of disease for PSMA-negative prostate cancer patients and, given the mounting clinical and preclinical data to date, we believe that it has potential to provide this large patient population with more accurate and precise detection and treatment of disease. SAR-Bombesin is a pan-cancer product, and the open IND offers exciting opportunities for exploring new theranostic indications with this versatile product as Clarity pursues our ultimate goal of improving treatment outcomes for children and adults with cancer."
Clarity’s Prostate Cancer clinical trial program overview
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 National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease8.