On November 26, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, reported that the patent application covering formulations of Clarity’s optimised Prostate Specific Membrane Antigen (PSMA) targeting agent, SAR-bisPSMA, has entered the national phase in multiple jurisdictions, including the USA, Europe and China (Press release, Clarity Pharmaceuticals, NOV 26, 2021, View Source [SID1234596096]). SAR-bisPSMA is a Targeted Copper Theranostic (TCT) for diagnosis and treatment of prostate cancer. A patent including claims covering the SAR-bisPSMA compound was recently granted in the USA, with an expiry date of 5 June 2038.

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SAR-bisPSMA has entered two clinical trials in July 2021:

SECuRE trial in the US: A 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 (NCT04868604)1
PROPELLER trial in Australia: Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study (NCT04839367)2
The prostate cancer market is a key focus for Clarity and the company is rapidly hitting key milestones in the development of SAR-bisPSMA with the recent completion of patient recruitment into the dosimetry phase of the SECuRE trial and ongoing recruitment in the PROPELLER trial.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with the evolving patent protection of one of our core products, SAR-bisPSMA, with the entry of the international application into the National Phase around the world. This further strengthens our position in the radiopharmaceutical field as we progress the clinical development of this asset in the US and Australia. This milestone is testament to Clarity’s strong emphasis on Intellectual Property (IP) protection since the inception of the company with a patent strategy designed to cover the SAR Technology platform as well as radiopharmaceutical products and the "Discovery Program" focused on developing new products and new IP for a range of cancer indications. This aggressive patent strategy allows us to gain strong protection with any targeting agent and expand our product pipeline, gaining a sustainable competitive advantage in this field."

This broad and deep patent strategy has resulted in the allowance and grant of a number of Clarity’s patent applications for key compounds in major jurisdictions, including patents for SARTATE and SAR-Bombesin. Clarity continues to extend its patent position with the recent filing of new provisional applications.

Dr Alan Taylor said, "Clarity’s patenting strategy enables us to successfully leverage our IP to develop a pipeline of next-generation radiopharmaceuticals and we are determined to fully exploit the broad coverage of the platform to continue pursuing our ultimate goal of developing better treatments for children and adults with cancer."

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