Clarity receives US FDA clearance of IND Application for its next-generation PSMA theranostic products

SYDNEY,May 4,2021 -- Clarity Pharmaceuticals,a clinical stage radiopharmaceutical company focused on the treatment of serious disease,is pleased to announce that it has received a response from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application that the study for selection and treatment of Prostate-Specific Membrane Antigen (PSMA) positive prostate cancers using 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA may proceed.

The SECuRE trial (Systemic Cu theranostics in prostate cancer) is a Phase I/IIa study for identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC),which will be conducted in the U.S. (NCT04868604)[1]. It is a theranostic multi-centre,single arm,dose escalation study with a cohort expansion planned for up to 44 patients. The trial employs diagnostic Positron Emission Tomography imaging with 64Cu-SAR-bisPSMA for selection of patients suitable for therapy cycles with 67Cu-SAR-bis-PSMA.

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of death worldwide[2]. The American Cancer Society estimates in 2021 there will be 248,530 new cases of prostate cancer in the U.S. and around 34,130 deaths from the disease[3]. For metastatic prostate cancer,the 5-year relative survival rate is 30%,indicating a high unmet need for early detection and better treatment options for mCRPC. Annually,there are around ~34,000 men in the U.S. who are diagnosed with mCRCP[3],~90% of whom have tumours which express PSMA[4].

Although there are some new therapeutic radiopharmaceutical agents for prostate cancer in late phase clinical trials,given the large patient population,product supply for therapeutic radiopharmaceuticals presents a constraint as they rely on the production of therapeutic isotopes from a small number of nuclear reactors,with reactor shutdowns often causing isotope shortages around the globe.

Clarity's SAR-bisPSMA product utilises two isotopes of copper,which do not have the same constraints:

The therapeutic product utilises copper-67,which is being produced domestically in the USA on electron accelerators,avoiding the issues commonly associated with the production of isotopes on nuclear reactors.

The diagnostic product utilises copper-64,which is regularly produced in significant volumes on cyclotrons in the U.S.,and has a half-life of 12.7 hours,avoiding the short half-life issues of other diagnostic isotopes.

The diagnostic and therapeutic products can be centrally manufactured and shipped as finished product direct to the treatment centres,which removes the need for dedicated radiopharmacy facilities at treatment centres.

Dr Alan Taylor,Clarity's Executive Chairman,commented on the IND approval,"The FDA response suggests not only the importance of developing novel treatments for men with late-stage prostate cancer,whose prognosis is currently very poor,but also validates Clarity's copper pairing paradigm and the centralised manufacturing concept,which differentiates it from the competitor products and enables product supply to the levels suitable for use in large patient indications."

"We are very excited to commence the SECuRE trial in mCRCP patients and have engaged a world class group of key opinion leaders in the prostate cancer space to support the development of 64/67Cu SAR-bisPSMA. Clarity's Global Clinical Development Group has unrivalled experience in the commercialisation of the only currently approved radiotherapeutic for prostate cancer. The FDA response is a crucial milestone in the development of SAR-bisPSMA theranostics and we are looking forward to progressing this trial at some of the leading cancer centres in the U.S. as part of our ultimate goal of developing better treatments for children and adults with cancer," said Dr Taylor

References

National Institute of Health,U.S. National Library of Medicine,https://clinicaltrials.gov/ct2/show/NCT04868604

World Cancer Research Fund,Prostate Cancer Statistics,https://www.wcrf.org/dietandcancer/cancer-trends/prostate-cancer-statistics

American Cancer Society,Cancer Statistics Center,https://cancerstatisticscenter.cancer.org/?_ga=2.79808020.284532473.1620009137-1916069442.1615761164#!/cancer-site/Prostate

D. A.Silver,I. Pellicer,W. R.Fair,W. D.Heston andC.Cordon-Cardo 1997. "Prostate-specific membrane antigen expression in normal and malignant human tissues." Clinical Cancer Research. vol. 3,81-85,January 1997

About Clarity

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals,developing targeted therapies based on its SAR Technology Platform for the treatment of cancer and other serious diseases in adults and children.

www.claritypharmaceuticals.com

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