US based COBRA diagnostic prostate cancer trial reaches recruitment target

SYDNEY, Feb. 9, 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 its diagnostic ⁶⁴Cu SAR-bisPSMA trial COBRA (NCT05249127)¹ for patients with prostate cancer has reached its recruitment target.

COBRA (Copper-64 SAR-bisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with 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-bisPSMA in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of ⁶⁴Cu-SAR-bisPSMA as well as its ability to correctly detect the recurrence of prostate cancer.

Dr Neal Shore MD, FACS Lead Principal Investigator in the COBRA trial and CMO – Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre, commented, "We are very pleased to have reached our recruitment target for the COBRA trial. The data generated thus far on the SAR-bisPSMA product is very encouraging and shows high uptake of the agent by prostate cancer cells. The high uptake of product and the ability to image the patients at later timepoints adds both patient and clinic flexibility for locating and visualising even low volume tumours, a unique feature of this imaging technology. It is important for improving prostate cancer recurrence detection where the cancer burden may be quite low and thus identifying the specific location provides clinically important implications for the patients' therapeutic selection. We look forward to analysing the COBRA trial data and advancing the clinical development of SAR-bisPSMA together with Clarity."

Clarity's Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with the progress in the development of the SAR-bisPSMA product across all of our trials, which continues to build a lot of excitement and was reflected by the pace of recruitment in the COBRA trial. In addition to potential clinical benefits due to higher uptake and the flexibility of imaging timepoints, ⁶⁴Cu SAR-bisPSMA has a number of logistical and manufacturing advantages in comparison to other currently used PSMA agents. The ready-to-use product has been shipped to the trial sites in the US from a central manufacturing facility on-demand and on time, providing flexibility and reliability to the patients and their treating staff. This facilitates expanding the radiopharmaceutical field into the large oncology market, minimising logistical and image timing hindrances associated with the current generation of radio-diagnostics, and helping to focus on the needs of patients and their clinicians.

"COBRA is our second diagnostic trial of SAR-bisPSMA in prostate cancer. It reaches its recruitment target shortly after receiving positive top-line results in our PROPELLER trial. Running two trials with this product is in line with advice received from the US FDA to address the two relevant patient populations for registration of ⁶⁴Cu SAR-bisPSMA: in pre-prostatectomy/pre-definitive treatment of patients with confirmed prostate cancer (PROPELLER trial); and in patients with suspected BCR of prostate cancer (COBRA trial).

"We look forward to analysing the data from the COBRA trial with a view to initiating a Phase III trial in this patient population."

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 worldwide². 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 disease³.

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.

www.claritypharmaceuticals.com

References

1. Clinicaltrials.gov Identifier: NCT05249127 https://clinicaltrials.gov/ct2/show/NCT05249127
2. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660 
3. American Cancer Society: Key Statistics for Prostate Cancer, https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

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This announcement has been authorised for release by the Executive Chairman.

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