3 industry partnerships, 1 clinical aim: Enriching the global supply chain of medical isotopes
Nuclear medicine operations may soon enjoy steadier flows of certain in-demand radioisotopes. If so, much credit will go to companies that had the strategic sense to collaborate with other suppliers working the same or similar territories.
Last week saw the rise of three such partnerships. In no particular order, here’s a rundown.
Clarity (New South Wales, Australia) and SpectronRX (South Bend, Indiana)
This two-continent arrangement, announced June 17, is expected to boost the availability of both copper-64 (Cu-64), which is often used in PET imaging and sometimes for radiotherapy, and 64Cu-SAR-bisPSMA, which is used with PET/CT to find or rule out prostate cancer. The latter works by using Cu-64 to specifically target tumor cells expressing the prostate-specific membrane antigen (PSMA) protein.
The commercial supply agreement is initially slated for a five-year stretch.
Under the announced terms, clinical-stage radiopharmaceutical firm Clarity will depend on developer and manufacturer SpectronRX for consistent access to 64Cu-SAR-bisPSMA, which is Clarity’s lead diagnostic product.
SpectronRx makes both that drug and Cu-64 at its Indiana facility. The company says the under-one-roof capability allows it to support distribution in all 50 states. The company adds that it can produce up to 400,000 patient-ready doses of 64Cu-SAR-bisPSMA annually from the one facility.
Further, the Clarity–SpectronRx partnership includes options to expand integrated 64Cu-SAR-bisPSMA manufacturing to additional locations in the U.S., according to the announcement.
Clarity says that, together with agreements it has made with other manufacturers, the work with SpectronRx helps create a “multi-layered and abundant approach.”
Ratio Therapeutics (Boston) and Nusano (West Valley City, Utah)
This agreement opens a direct channel for pharma firm Ratio to distribute high volumes of copper-64 (Cu-64) made by physics company Nusano for PET imaging, according to a June 17 announcement sent by Ratio.
The deal also gives Ratio ready access to Nusano’s lutetium-177 (Lu-177) and actinium-225 (Ac-225), both of which are used in radiation therapy.
Nusano says it operates a proprietary platform capable of generating more than 40 different isotopes for medical and industrial applications. The company adds that it intends to use these capabilities to “help stabilize the existing medical radioisotope market and enable oncology innovation by providing researchers and drugmakers with isotopes yet to be fully explored for their cancer-fighting properties.”
The collaboration came about thanks to Ratio’s opening of a new manufacturing facility in Utah close to Nusano’s operations. Paired with a “shared vision” for speeding innovation in the fast-growing radiopharma field, the arrival of Ratio into Nusano’s neighborhood will facilitate logistics involving scale-ups and deliveries, the companies suggest.
“Leveraging its proprietary Trillium platform, Ratio is designing highly selective, targeted radiotherapeutics for cancer treatment,” the announcement states, “including a fibroblast activation protein (FAP)-targeted radiotherapy in development for soft tissue sarcoma.”
The company expects the drug to enter clinical settings this year.
Ratio chair and CEO Jack Hoppin, PhD, says that, up till now, Cu-64’s limited supplies and high costs have hampered the drug from reaching its clinical potential.
“By accessing Nusano’s production capabilities, we’re removing a critical bottleneck and enabling broader adoption across the field,” Hoppin adds.
ITM Isotope Technologies (Munich, Germany) and Institut Laue-Langevin (ILL, Grenoble, France)
Receiving a production and distribution boost from this pairing is Lutetium-177 (Lu-177). The drug is primarily used to treat cancer and secondarily to diagnose it.
The ITM-ILL collaboration is already well established, dating to 2009, but on June 16 the companies announced their intent to intensify the partnership so they can make Lu-177 more widely and readily available around the world.
Under the terms of the refreshed arrangement, ITM will receive priority access to half of the available neutron irradiation capacity at ILL’s high-flux reactor. Of greatest interest is the neutron irradiation facility’s production of non-carrier-added Lu-177, which has been rising as a go-to radioisotope for targeted radionuclide therapy.
ITM chief executive Andrew Cavey, MD, MPH, says his company’s key interest is ongoing access to ILL’s “renowned high-flux irradiation services. … [This] is incredibly important as the demand for non-carrier-added Lutetium-177 grows and as our radiopharmaceutical pipeline evolves.”
The announcement says the high neutron flux of ILL’s reactor provides ITM with an especially high yield of Lu-177, allowing for a particularly sustainable production of the medical radioisotope by minimizing use of the scarce precursor raw material Ytterbium-176 (Yb-176).
ILL director Ken Andersen, PhD, says the extended agreement with ITM will advance the company’s work providing irradiation products “at exceptionally high neutron flux” to serve both cancer-fighting clinicians and particle-physics researchers.
“ILL is proud of the longstanding collaboration with ITM, regularly performing irradiations of Ytterbium-176 targets for ITM over the last 15 years, and looks forward to an even closer partnership in the coming years,” Andersen underscores.
For an overview of factors hindering and helping the global supply chain of nuc med drugs—especially issues affecting two of the most high-demand isotopes, molybdenum-99 (Mo-99) and technetium-99m (Tc-99m)—don’t miss Why is the US still dependent on foreign medical isotope production?