A new manufacturing force is stirring on the nuclear medicine scene.
With their forces—and cash—combined, venture capital outfit Eclipse and Mayo Clinic have teamed up to provide seed funding for new CDMO Nucleus RadioPharma. The company recently debuted a mission to boost radiopharmaceutical access by cranking out new technologies to modernize development, production and supply of the promising cancer meds.
While radiopharmaceuticals have much to offer in oncology, their success has been “broadly hampered” by manufacturing and supply chain woes, Nucleus said in its inaugural press release.
Radiopharmaceuticals or radiotherapies are essentially guided radioactive drugs. Smaller amounts can be used to help diagnose diseases, while larger amounts can be used to treat certain kinds of cancer and other conditions, according to Mayo Clinic. In those cases, the radioactive agent is taken up in the cancerous area and destroys the affected tissue.
Supply chain efficiency is “absolutely critical” for radiopharmaceutical production given their “time-sensitive nature,” Charles Conroy, CEO of Nucleus, explained over email. Radioactive materials begin to decay within a short period of time, he said, leaving “just days between manufacturing and injection to ensure the proper dose is received.”
In addition to that, the radioactive nature of the therapies warrants unique handling and regulatory compliance, plus special training, Conroy added.
Problem is, often after a patient is approved to receive a radiotherapy, current supply chain limitations can force them to wait for more than a month for the treatment to be manufactured and delivered to the hospital.
Nucleus aims to remedy these ills by folding development, manufacturing and supply into a single entity.
While it’s still early days for the new company, Nucleus plans to have initial manufacturing facilities in Rochester, Minnesota, which will allow it to work closely with Mayo Clinic, Conroy said.
Meanwhile, with Eclipse and Mayo’s support, Nucleus plans to expand both its team and facilities “rapidly,” with more details to share on those fronts “in the coming months,” Conroy said.
Conroy did not comment on whether the company has received interest so far from major radiopharmaceutical players like Novartis.
Speaking of Novartis, the Swiss pharma juggnernaut is also stepping up its radiotherapy production game after a manufacturing hitch in May that stopped supply of two of the company’s marketed cancer drugs, Lutathera and Pluvicto. In late June, Novartis said it had fixed the quality issues that led to voluntary production halts at its radioligand therapy sites in Italy and New Jersey. The company said it had resumed production earlier that same month and even telegraphed plans to expand at both campuses.
Aside from capacity-boosting projects in Italy and New Jersey, Novartis in 2020 unveiled blueprints for a radiotherapy manufacturing plant at Indianapolis’ Purdue Research Park. With 50,000 square feet of production space, the project is expected to begin operations in 2023.