Gallium Dotatate Ga-68

SYDNEY, Nov. 30, 2023 /PRNewswire/ -- 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, is pleased to announce it has commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)[1], with the initiation of the first clinical site at the Urology Cancer Center / XCancer Omaha, NE. The aim of the CLARIFY study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA to detect regional nodal metastasis in participants with high-risk prostate cancer prior to radical prostatectomy. The study expects to recruit 383 participants at multiple clinical sites across the United States and Australia. Evaluation will take place over 2 imaging timepoints, day 1 (day of administration) and day 2 (approximately 24 hours post administration). CLARIFY is expected to image the first participant in late 2023. As a registrational trial, the final study results are intended to provide sufficient evidence to support an application to the US FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "We are excited to commence our first registrational Phase III trial with our optimised SAR-bisPSMA agent. The CLARIFY trial is based on compelling preclinical and clinical data, including our completed PROPELLER trial (NCT04839367)[2,3]. It demonstrated the excellent safety profile and superior performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 also in patients with prostate cancer prior to radical prostatectomy, guiding the study design for the CLARIFY trial. Despite the improvement of management and staging of patients with prostate cancer introduced by PSMA PET compared to other conventional imaging, low cancerous lesion uptake by PSMA agents may have an impact on clinical management. The PROPELLER trial showed significantly higher uptake of 64Cu-SAR-bisPSMA in PSMA-expressing lesions compared to an approved standard-of-care PSMA imaging agent, potentially enabling the diagnosis of additional and smaller lesions[2,3]. CLARIFY will also investigate the benefits of delayed imaging in this patient group, a feature that has shown real benefits to patients so far and is not available with the first-generation PSMA imaging agents using gallium-68 or fluorine-18, which have very short half-lives and exhibit low sensitivity in detecting cancerous lesions. Additionally, the extended shelf-life of up to 48 hours offered by 64Cu-SAR-bisPSMA not only provides greater flexibility for clinics in scheduling diagnostic scans, but also improves patient access to care, including areas with limited access to diagnostic radiopharmaceuticals in prostate cancer due to the short shelf-life of existing PSMA PET tracers. "The prostate cancer market is a key focus area for Clarity as there is a high unmet need for diagnostics and therapy, and we believe our theranostic SAR-bisPSMA product has the potential to improve diagnosis, therapy and ultimately change patients' lives. We look forward to progressing this trial to validate and expand upon the positive data we have accumulated so far with our SAR-bisPSMA product. With this trial, our aspiration is that with improved diagnostic tools, clinicians will be empowered to make more informed decisions regarding the best course of treatment for their patients." About SAR-bisPSMA SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagene (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-bisPSMA is a 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. 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide[4]. 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 disease[5]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults. This announcement has been authorised for release by the Executive Chairperson. SOURCE Clarity Pharmaceuticals

Novartis’ Advanced Accelerator Applications division has received diagnostic approvals for Netspot and SomaKit, which label neuroendocrine tumors for imaging scans; Locametz, in prostate cancer; and Gluscan, to help track diseases through glucose metabolism. Novartis is looking to offload part of its catalog of diagnostic radiopharmaceutical agents, held under its Advanced Accelerator Applications portfolio, according to a report from Bloomberg.  These injections pair a radioactive marker with a binder designed to attach to specific proteins that may be overexpressed by certain cancer cells to highlight them for imaging scanners and help outline tumors of the brain, prostate, gastrointestinal system and elsewhere. According to the report, the Swiss Big Pharma is in the early stages of shopping around for a buyer—specifically for its diagnostic agents—and deliberations are ongoing. Novartis’ AAA division also markets and develops anti-cancer therapies using the same molecular binders—by swapping out a weaker radioactive isotope for a stronger one, it aims to turn precision diagnostic imaging agents into tumor-cell-killing drugs.  For example, the company’s pipeline lists two products in early development targeting a protein found on the surface of cells that help feed blood to growing glioblastoma brain tumors: one employing a gamma-ray-emitting isotope of gallium, used in diagnostic PET/CT scans, while the other taps lutetium-177, which emits damaging beta particles. Lutetium-177 also powers the therapeutic Lutathera—which Novartis recently pitched as a potential first-line therapy in gastroenteropancreatic neuroendocrine tumors, also known as GEP-NETs, following a successful phase 3 trial last month that combined it with the synthetic hormone Sandostatin.  AAA has also received diagnostic approvals for Netspot and SomaKit, which use gallium-68 to label neuroendocrine tumors; Locametz, which employs the same radioisotope in prostate cancer; and Gluscan, which helps track glucose metabolism with fluoride-18.   Novartis has been looking to slim down over recent years and has undergone major restructuring while setting up a spinout of its Sandoz generic drug division, slated for this week. Last year, it also unloaded five eye drugs to ophthalmic company Harrow, and this past summer handed off the dry eye disease eyedrop Xiidra, plus other assets, to Bausch + Lomb in a $2.5 billion deal. Novartis first acquired AAA, a spinout from CERN launched in 2002, through a $3.9 billion deal in late 2017.  Radiopharmaceuticals have attracted recent strong investor interest. RayzeBio, a 2023 Fierce 15 winner, previously assembled about $418 million across four venture capital rounds before going public through a mammoth $311 million IPO this past September. RayzeBio’s lead therapeutic candidate uses the same binder as Novartis’ Lutathera to also target GEP-NETs but swaps out lutetium-177 for actinium-225—an isotope that emits more destructive alpha particles, capable of delivering hundreds of times the energy within a much smaller radius, amounting to just a few widths of a cell. Meanwhile, today Eli Lilly announced the acquisition of Point Biopharma Global to join the cancer radiopharmaceutical arena for $1.4 billion. Point’s two lead therapeutic programs are aimed at metastatic castration-resistant prostate cancer and GEP-NETs.