GU Research Network, LLC

SYDNEY, Oct. 7, 2022 /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 the dosing of the first patient in the therapeutic phase of its Phase I/II theranostic trial evaluating 64Cu/67Cu SAR-bisPSMA theranostic products in patients with metastatic, castrate-resistant prostate cancer (mCRPC). The SECuRE trial (NCT04868604)[1] is a Phase I/IIa theranostic trial for identification and treatment of Prostate-Specific Membrane Antigen (PSMA) expressing mCRPC using Targeted Copper Theranostics (TCTs). 64Cu SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients in the US. The aim of this trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA as a therapy. The SECuRE trial initially underwent the dosimetry phase with 64Cu SAR-bisPSMA to determine product biodistribution and dosimetry over multiple time points. Upon the completion of the phase, the data was collected and reviewed by the Safety Review Committee, which has recommended the trial progresses into therapeutic applications with 67Cu SAR-bisPSMA. The first patient in the therapeutic phase was treated at the Urology Cancer Center and GU Research Network in Omaha, Nebraska. Dr Luke Nordquist, CEO, Urologic Medical Oncologist and Principal Investigator at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are excited to have successfully treated the first participant with the therapeutic 67Cu SAR-bisPSMA product. The preclinical and preliminary clinical data to date indicates potential diagnostic and therapeutic benefits of the optimised PSMA agent and we look forward to generating further evidence as we progress the recruitment into the SECuRE trial. "GURN is now recruiting participants in three clinical trials with Clarity's TCTs. We firmly believe that this next-generation platform will help to overcome the logistical and manufacturing challenges that currently plague the radiopharmaceutical field. With an on-demand distribution model that alleviates the reliance on antiquated nuclear reactors, TCTs hold great promise of shifting the treatment paradigm towards the patients and their treatment staff. This way, the clinicians can focus on providing the best patient care without the fear of reactor shutdowns or manufacturing outages disrupting the treatment process." Clarity's Executive Chairman, Dr Alan Taylor, commented, "Clarity is excited to progress our second theranostic trial and continue exploring the benefits of TCTs. Prostate cancer is one of the largest oncology indications and there is a significant unmet need for improved diagnosis and therapy of patients with this insidious disease. Moreover, the preliminary data suggests the optimised PSMA product could deliver clinical benefits in oncology indications beyond prostate cancer, which we are excited to explore in the near future. "Radiopharmaceuticals have a great opportunity of advancing the treatment paradigm for cancer patients, however, a number of challenges associated with the current generation products prevail. Firstly, production of currently approved therapeutic radiopharmaceuticals relies on an ageing fleet of nuclear reactors where shutdowns and interruptions are common. In addition, most currently approved therapeutic products need to be heated during the manufacturing process, which can cause potential quality issues. Finally, as the radiopharmaceutical field is expanding in the global oncology market, the environmental considerations, associated with inefficient supply chains and production of radioactive waste, become a concern. "Clarity's TCTs are the next-generation platform that aims to resolve these challenges and enable the radiopharmaceutical field to expand significantly in the large oncology market, addressing multiple large cancer indications. Our therapeutic products are based on copper-67 radioisotopes produced on electron accelerators, which are relatively inexpensive and infinitely scalable in comparison to medical nuclear reactors. TCTs also do not require heating during the manufacturing process, making it less costly and minimising quality concerns. Production of TCTs has favourable environmental characteristics in comparison to the current generation of theranostics with smaller infrastructure footprint and minimal radioactive waste disposal issues. In a field with too many unforeseen product outages and manufacturing issues, TCTs enable reliable and sustainable supply of radiopharmaceuticals. "Given the myriad of logistical and manufacturing advantages of TCTs, we are committed to further validating the promising preclinical and clinical data to date and driving SAR-bisPSMA development in prostate cancer as well as other oncology indications with high unmet need," said Dr Taylor. About SAR-bisPSMA SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs 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 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 worldwide[2]. 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 disease[3]. 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.

SYDNEY, Oct. 6, 2022 /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 successfully imaged its first participant in the US-based diagnostic 64Cu SAR-Bombesin trial (SABRE NCT05407311)1 for patients with PSMA-negative prostate cancer. SABRE (Copper-64 SAR-BisPSMA in Biochemical Recurrence of prostate cancer) is a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer. Dr Luke Nordquist, CEO, Urologic Medical Oncologist and Principal Investigator at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are very excited to have recruited and imaged the first participant in this trial which will explore the clinical benefits of the novel SAR-Bombesin agent. Based on the promising preclinical and clinical data to date, SAR-Bombesin shows great potential for improving the diagnosis and treatment for not only patients with prostate cancer that are PSMA negative, but also across broader prostate cancer indications. "SABRE is the third trial with Clarity's Targeted Copper Theranostics (TCTs) that GURN is recruiting into. This momentum is underpinned by our belief that the TCTs are the next-generation products that will enable the radiopharmaceutical field to overcome the manufacturing and supply chain challenges associated with the current products in the market and facilitate the expansion of radiopharmaceuticals into the large global oncology market. We look forward to generating data from the trial to validate the potential clinical benefits for large patient populations and improve patient care." Clarity's Executive Chairman, Dr Alan Taylor, commented, "We are very excited to progress the SABRE trial in the United States as we are already seeing an improved treatment paradigm in the management of PSMA-negative disease for patients with SAR-Bombesin who were imaged under the Therapeutic Goods Agency's Special Access Scheme in Australia2. "Given the data to date indicates the potential diagnostic and therapeutic benefits of SAR-Bombesin, we look forward to generating further evidence as we accelerate the product to market. Subject to the outcome of the SABRE trial, Clarity is planning to launch a pivotal Phase III diagnostic trial for first product approvals in the US. We are also preparing to run a theranostic trial with an Investigational New Drug (IND) application scheduled for submission to the US Food and Drug Administration (FDA) later this year. We look forward to progressing our SAR-Bombesin program and potentially providing a large patient population with accurate and precise detection and treatment of their prostate cancer," said Dr Taylor. 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)3-7. 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 worldwide8. 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 disease9. Approximately 20% of prostate cancers with BCR are PSMA-PET negative10-13. 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. 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 Chairman. SOURCE Clarity Pharmaceuticals

Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, is pleased to announce that an investigator-initiated trial (IIT) will commence shortly in the US investigating 64Cu SAR-bisPSMA in prostate cancer (NCT05286840)[1}. The X-Cancer's investigator-led trial of SAR-bisPSMA in known or suspected prostate cancer (X-Calibur) is a Phase I/II IIT in up to 150 patients at the Urology Cancer Center and GU Research Network (GURN) in Omaha, Nebraska, sponsored by Dr Luke Nordquist. It will investigate a broad spectrum of prostate cancer patients by imaging with 64Cu-SAR-bisPSMA on the day of administration and at later timepoints. The X-Calibur trial will be assessing the safety of 64Cu SAR-bisPSMA as well as looking at the impact of the product on staging and clinical management of participants with prostate cancer. Clarity's Executive Chairman, Dr Alan Taylor, commented, "We are excited to support Dr Nordquist's trial, who has had first-hand experience with our products in the theranostic 64Cu/67Cu SAR-bisPSMA SECuRE trial (NCT04868604)[2]. We look forward to continuing to work together on progressing the development of our optimised SAR-bisPSMA agent in prostate cancer and exploring the many benefits of this product as part of Clarity's Targeted Copper Theranostics (TCT) program in pursuit of our ultimate goal of improving treatment outcomes for cancer patients." Prostate cancer is a key focus of Clarity's Targeted Copper Theranostics (TCT) program, where the IIT at GURN is the fourth clinical trial utilising the SAR-bisPSMA agent in prostate cancer. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)[2], has been able to successfully image patients with metastatic castrate resistant prostate cancer from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)[3], is well underway, with over 50% of participants recruited in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy). The most recent diagnostic 64Cu SAR-bisPSMA trial in the US, COBRA (NCT05249127)[4], has received a Study May Proceed Letter from the FDA in February 2022, with recruitment of participants with biochemical recurrence of prostate cancer planned to commence in the second quarter of 2022. Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence. Dr Luke Nordquist, CEO and Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are very impressed with the PET imaging data collected at GURN from the SECuRE trial which indicates high tumour targeting and retention, especially compared to first-generation PSMA agents that use a single PSMA binding motif and have very short half-lives of 1-2 hours. As such, we were excited to seize the opportunity and continue the development of SAR-bisPSMA in the diagnostic IIT at GURN, continuing to further expand the clinical benefits of the product and to provide our own prostate cancer patients with the very best technologies available. "In addition to the clinical advantages, we have also been excited about the supply and logistical benefits of SAR-bisPSMA as a TCT, which can be distributed on-demand and in large scale from central manufacturing facilities. TCT can provide universal access to radiopharmaceuticals in every zip-code in the continental US, something that is lacking with current approved agents. GURN has a significant backlog of patients who cannot access sufficient quantities of PSMA imaging agents based on gallium-68 (Ga-68) or fluorine-18 (F-18) due to the logistical issues of short half-life isotopes. We have already experienced the benefits of Cu-64 based products and their longer shelf-life of up to 48 hours with our current trial with Clarity, and we expect minimal delays and interruptions as we look to address the large backlog of treatments, providing up to 150 prostate cancer patients with the critical imaging required to improve patient outcomes." Dr Taylor said, "This fourth clinical trial of SAR-bisPSMA will build on the exciting data to date as we progress this product towards the market. The trial will also continue to demonstrate the numerous benefits of the centrally manufactured, on-demand distribution model of ready-to use cGMP TCT products over the first-generation short half-life products using Ga-68 and F-18. We look forward to Dr Nordquist advancing the X-Calibur trial and hope it will improve cancer diagnosis and ensure that critical treatments will be available to patients and their treating staff on time and at a convenient location when and where they need it most." This announcement has been authorised for release by the Executive Chairman.