Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX: CU6) has entered into a supply agreement with SpectronRx for the production of Cu-64.
“We are very excited to bring an additional Cu-64 manufacturer to our extensive and reliable network of copper radioisotope suppliers. SpectronRx will be the first private supplier of Cu-64 to join our network in the US,” Clarity’s Executive Chairperson, Dr Alan Taylor, said.
“Cu-64, with an ideal 12.7-hour half-life, is able to overcome the overwhelming supply restraints of other diagnostic isotopes, specifically Ga-68 with a half-life of ~1 hour and F-18 with a half-life of ~2 hours. Radiopharmaceutical products using these isotopes are severely limited and are associated with significant manufacturing and supply complications, driven by these very short half-lives. This leaves many patients around the world with no option of positron emission tomography (PET) imaging. This is well documented in the United States, the largest oncology market in the world, and the effects of these hurdles more heavily impact vulnerable populations, including African Americans and Veterans, who already experience much higher incidences of prostate cancer than the general population.
“Our focus at Clarity is to establish the most reliable, scalable, and logistically seamless supply chain in the radiopharmaceutical field to continue delivering our best-in-class products to patients and their clinicians on time. With our TCTs, we can avoid the myriad of challenges associated with the current generation of diagnostic isotopes, such as Ga-68 and F-18, which require local production due to their short half-lives.
“The unique properties of Cu-64 include the ability to produce commercially relevant volumes of this isotope daily, on centrally located cyclotrons. Cu-64 can then be manufactured into ready-to-use products with a shelf life that is measured in days rather than hours and supply the growing demand for PET imaging agents. Should an imaging site require 1, 10 or 100+ patient doses, we see a future where these quantities can be reliably supplied to any zip code in the United States, removing the burden of the current supply issues with Ga-68 and F-18 based products from practices and their patients.
“We are now actively recruiting and imaging patients for our first Phase III trial with 64Cu-SAR-bisPSMA in a pre- prostatectomy setting and planning our second Phase III trial in biochemically recurrent prostate cancer with this optimised product. With outstanding clinical trial data to date, we continue to implement our strategy for the commercial launch of 64Cu-SAR-bisPSMA, developing a seamless supply chain for this potential best-in-class agent.”
The overarching Master Service Agreement and associated Cu-64 supply agreement are effective as of 30 May 2024. The initial supply from SpectronRx is expected to launch before the end of calendar year 2024. The Master Services Agreement is for an initial period of five years and the Cu-64 supply agreement is for an initial period of three years.
