Highlights
- Clarity has entered into a 64Cu-SAR-bisPSMA Clinical Manufacturing Agreement for its Phase III clinical trials with SpectronRx.
- This Clinical Manufacturing Agreement builds on the earlier Master Service Agreement and associated Supply Agreement for the copper-64 (Cu-64 or 64Cu) isotope with SpectronRx, effective as of 30 May 2024.
- SpectronRx will produce both the 64Cu isotope and the 64Cu-SAR-bisPSMA product at the same facility in the US.
- As Clarity is progressing 2 registrational Phase III trials with 64Cu-SAR-bisPSMA, this agreement ensures abundant and seamless supply with central distribution of the product from SpectronRx facility in Indiana to all 50 states on demand, providing universal access to this agent for the pivotal trials.
SpectronRx’s facility enables on-demand 64Cu-SAR-bisPSMA manufacturing and distribution to all 50 states. This provides reliable, universal access of 64Cu-SAR-bisPSMA in the U.S. for Clarity’s Phase III trials, including the ongoing CLARIFY trial in the pre-prostatectomy setting, as well as the upcoming pivotal trial for prostate cancer patients with biochemical recurrence (BCR). The agreement with SpectronRx complements Clarity’s existing supply network, providing a layered and abundant supply approach, which is unique in the radiopharmaceutical space.
Clarity’s Executive Chairperson, Dr. Alan Taylor, commented, “We are excited to continue strengthening our supply network, ensuring vulnerable patients in need of novel diagnostic options can get access to what we believe is a best-in-class product, on time and at any treatment centre with a positron emission tomography (PET) camera.
“Current-generation radiopharmaceutical diagnostic products rely on isotopes with very short half-lives, specifically Ga-68 with a half-life of ~1 hour and F-18 with a half-life of ~2 hours, which translate into short shelf-lives of the diagnostic products. This limits the use of these products to large treatment centres and hospitals with radiopharmacy facilities nearby that can produce F-18 and/or Ga-68. 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. At Clarity, we believe that this approach has the potential to reduce disparities in prostate cancer care, providing patients with access to next-generation imaging products, regardless of their geographic location.”SpectronRx has a proven track record in generating multi-curie activities, representative of hundreds of patient doses, in a short irradiation window. SpectronRx also has in-house target preparation and integrated recycling facilities for Ni-64, the starting material for Cu-64 production. As such, the leftover Ni-64 after the initial production cycle can be recycled at SpectronRx. This avoids the inefficiencies, low yields, and costs associated with the use of third-party systems for Ni-64 target production and target recycling that are more suited to small-scale on-site cold kit labeling.
“We look forward to swiftly progressing our Phase III trials with the assurance of abundant product supply and seamless distribution across the U.S. as we are getting closer to our ultimate goal of improving treatment outcomes for people with cancer,” Dr Taylor said.The Clinical Manufacturing Agreement is effective as of 8 October 2024 and is for an initial period of 24 months. Cancellation and extension provisions are aligned with industry-standard rates.
Source: Clarity enters a Clinical Manufacturing Agreement for Cu-64 SAR-bisPSMA with SpectronRx