Clarity Pharmaceuticals and SpectronRx Partner for Phase III Trial Manufacturing of Cu-64 SAR-bisPSMA
Key Insights
Clarity Pharmaceuticals (search) partners with SpectronRx for manufacturing Cu-64 SAR-bisPSMA (search), ensuring reliable supply for Phase III trials.
The agreement supports trials including CLARIFY (pre-prostatectomy) and a pivotal trial for prostate cancer (search) patients with biochemical recurrence.
Cu-64's 12.7-hour half-life overcomes supply limitations of shorter-lived isotopes like Ga-68 and F-18.
Clarity Pharmaceuticals (search) (ASX: CU6) has entered into a Clinical Manufacturing Agreement with SpectronRx for the production of 64Cu-SAR-bisPSMA, a diagnostic radiopharmaceutical, for its Phase III clinical trials. This agreement aims to streamline the manufacturing process by producing both the 64Cu isotope and the 64Cu-SAR-bisPSMA product at SpectronRx’s facility.
The collaboration ensures reliable and universal access to 64Cu-SAR-bisPSMA across all 50 U.S. states for Clarity’s ongoing CLARIFY trial in the pre-prostatectomy setting and an upcoming pivotal trial for prostate cancer (search) patients experiencing biochemical recurrence (BCR). The agreement complements Clarity’s existing supply network, establishing a robust and layered supply approach.
Overcoming Isotope Supply Limitations
Dr. Alan Taylor, Executive Chairperson of Clarity, highlighted the advantages of Cu-64 over current-generation radiopharmaceuticals that rely on isotopes with short half-lives, such as Ga-68 (1 hour) and F-18 (2 hours). These isotopes limit product use to large treatment centers with nearby radiopharmacy facilities. Cu-64, with its 12.7-hour half-life, allows for central manufacturing and distribution across the U.S., potentially reducing disparities in prostate cancer (search) care.
"Current-generation radiopharmaceutical diagnostic products rely on isotopes with very short half-lives... This limits the use of these products to large treatment centers and hospitals with radiopharmacy facilities nearby... Cu-64 has an ideal 12.7-hour half-life and can overcome the overwhelming supply restraints of other diagnostic isotopes through central manufacture and distribution across the U.S. from a single facility," said Dr. Taylor.
SpectronRx's Capabilities
SpectronRx’s facility is capable of generating multi-curie activities, representing hundreds of patient doses, within a short irradiation window. The facility also features in-house target preparation and integrated recycling facilities for Ni-64 (search), the starting material for Cu-64 production, enhancing efficiency and reducing costs.
The Clinical Manufacturing Agreement is effective from October 8, 2024, for an initial period of 24 months, with standard industry cancellation and extension provisions.