On September 12, 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 that the patent application covering Clarity’s optimised Prostate Specific Membrane Antigen (PSMA) targeting agent, SAR-bisPSMA, has been Granted in China (Press release, Clarity Pharmaceuticals, SEP 12, 2022, View Source [SID1234619387]).
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The patent had been previously granted in the USA, Australia and Mexico and has an expiry date of 5 June 2038. The patent application remains under review in other major jurisdictions, including Europe and Japan.
SAR-bisPSMA is a Targeted Copper Theranostic (TCT) for diagnosis and treatment of prostate cancer as well as other cancers expressing PSMA. The prostate cancer market is a key focus for Clarity as the company continues to hit key milestones in the development of SAR-bisPSMA in three clinical trials:
SECuRE theranostic trial in the US
Phase I/IIa theranostic study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC) (NCT04868604)1
Status: Therapy phase open for recruitment
PROPELLER diagnostic trial in Australia
Positron Emission Tomography (PET) imaging of participants with confirmed prostate cancer using 64Cu-SAR-bisPSMA: a multi-centre, blinded review, dose ranging Phase I study (NCT04839367)2
Status: Recruitment complete
COBRA diagnostic trial in the US
Phase I/II PET imaging trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy using 64Cu SAR-bisPSMA in the US (NCT05249127)3
Status: Recruiting
Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with our broad and evolving patent protection for all of our products, but in particular for one of our core products, with this composition-of-matter patent now granted in the USA, Australia, China and Mexico. This further strengthens our position as we progress the clinical development of SAR-bisPSMA. This milestone continues Clarity’s strong emphasis on Intellectual Property (IP) protection covering the SAR Technology platform and each new product that stems from it.
"Clarity’s aggressive patenting strategy enables us to successfully leverage our IP to achieve strong protection and develop a pipeline of next-generation radiopharmaceuticals. This allows us to gain a sustainable competitive advantage in the field as we continue pursuing our ultimate goal of developing better treatments for children and adults with cancer."