On May 6, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Patent and Trademark Office (USPTO) has granted the patent application for Clarity’s SAR-bisPSMA compound and its variants (Press release, Clarity Pharmaceuticals, MAY 6, 2021, View Source [SID1234579259]). The grant of the patent application bolsters Clarity’s strong Intellectual Property (IP) position on the Prostate Specific Membrane Antigen (PSMA) targeting agent for imaging and treatment of prostate cancer.

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SAR-bisPSMA is the result of Clarity’s optimisation of the well characterised PSMA targeting peptide, which has been in many thousands of patients to date, by combining two PSMA targeting peptides with Clarity’s proprietary SAR Technology and the theranostic isotopes of copper, copper-64 for imaging and copper-67 for therapy. The copper pairing enables diagnosis, staging and subsequent treatment of prostate cancers that express PSMA. The optimisation of the targeting peptide has resulted in superior targeting of, and retention in, tumours compared to a singular PSMA targeting peptide in preclinical models (Zia et al., 2019)1. The product was developed through the long-standing collaboration between Clarity and Professor Paul Donnelly at the University of Melbourne.

Clarity’s Executive Chairman, Dr Alan Taylor, commented: "The grant of the SAR-bisPSMA patent application is an example of the effectiveness of Clarity’s broad patent strategy around its SAR Technology, which allows the filing of additional patents with a wide range of new disease targeting agents."

The news from the USPTO come shortly after Clarity has completed the assignment of its key patent portfolio from the University of Melbourne, providing Clarity with the full rights and ownership of the patents.

"The grant of the SAR-bisPSMA patent application also comes soon after Clarity received a response from the U.S. Food and Drug Administration on its an Investigational New Drug (IND) application for a theranostic trial of 64Cu/67Cu SAR-bisPSMA in the U.S. (NCT04868604)2 that the study may proceed. With our diagnostic trial of 64Cu SAR-bisPSMA in previously diagnosed but yet untreated patients prior to surgical removal of the prostate in the start-up phase (NCT04839367)3, we are now ready to embark on two clinical trials of SAR-bisPSMA in the next few months," said Dr Taylor.

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of death worldwide4. 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 disease5. 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 mCRCP5, ~90% of whom have tumours which express PSMA6.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The theranostic SAR-bisPSMA product has blockbuster market potential for prostate cancer. The product has ideal characteristics for a radiopharmaceutical and numerous advantages associated with the optimisation of the targeting peptide and using the copper pairing, including increased targeting and retention of the product in tumours, centralised manufacture, reaching more treatment sites and patients around the world, as well as diagnostic, dosimetry and therapeutic benefits. We are excited to progress the development of this proprietary asset into the clinic for the treatment of men with prostate cancer as part of our ultimate goal of improving treatment outcomes for kids and adults with cancer. We are pleased to have received the patent grant to reinforce Clarity’s IP position around our PSMA compounds, giving us confidence in the commercialisation process moving forward."