CDMO Nucleus RadioPharma links up with ARTBIO to help produce prostate cancer candidate for clinical trials

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来源: FiercePharma

Nucleus RadioPharma has previously said the success of radiopharmaceuticals has been “broadly hampered” by manufacturing and supply chain woes.

Following Nucleus RadioPharma’s 2022 debut, the GE HealthCare- and Mayo Clinic-backed radiopharmaceuticals CDMO is ready to put its production thesis to the test.

Nucleus on Tuesday revealed that it has signed its first commercial partnership with clinical-stage radiopharma player ARTBIO. Under the deal, Nucleus is on deck to help manufacture ARTBIO’s Pb212-radiolabeled therapies from its facility in Rochester, Minnesota.

The production deal will support ARTBIO’s planned phase 1 and 2 clinical trials of its lead program in prostate cancer, AB001, the companies noted. The financial terms of the deal were not disclosed.

Nucleus, which was founded by venture capital firm Eclipse and the Mayo Clinic in October 2022, touts itself as the world’s first fully integrated development, manufacturing and supply chain organization for radiopharmaceuticals.

The company is developing multiple sites around the U.S. to help make delivery of "scarce, hard-to-manufacture" nuclear medicines more efficient by cutting production timelines and easing supply chain constraints, Nucleus' CEO Charles Conroy said via email.

Radiopharmaceuticals, also known as radiotherapies, are essentially guided radioactive drugs that can be used to help diagnose diseases in smaller amounts and treat certain cancers and other conditions in higher quantities.

The field has attracted significant interest in recent years, but the unique makeup and characteristics of the drugs often raise manufacturing and logistical concerns. Novartis, which makes the radiopharmaceuticals Lutathera and Pluvicto, had to temporarily stop producing the drugs in May 2022 thanks to potential quality issues at sites in Ivrea, Italy, and Millburn, New Jersey.

Novartis has since resolved the issues and subsequently charted a number of major radiotherapy production expansions.

For its part, Nucleus has previously suggested the success of radiopharmaceuticals has been “broadly hampered” by manufacturing and supply chain woes. It has already wooed major investors to help address these concerns.

Last October, the CDMO ginned up an oversubscribed, $56 million, series A investment round led by Eclipse and GE HealthCare, which Nucleus said it would use to fund new facilities in the U.S.

ARTBIO, for its part, launched last summer. Less than six months after its debut, the biotech secured a $90 million series A round to build out its radiotherapy platform, solidify its manufacturing network and enter the clinic with a lead asset.

Partnerships and production advances in the radiotherapy field have been coming at a steady clip in 2024.

In January, Novartis snared FDA approval to begin cranking out commercial doses of Pluvicto at its “largest and most advanced” radiotherapy plant in Indianapolis.

The following month, Bayer enlisted production specialist PanTera to crank out the alpha-emitting isotope actinium-225 (Ac-225) for clinical trial needs starting in the second half of 2024.

Meanwhile, Australia’s Telix Pharmaceuticals recently inked back-to-back buyouts of Texas-based CDMO IsoTherapeutics and Canada’s ARTMS Inc.

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