预约演示

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

2024-05-07

并购放射疗法

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

Nucleus RadioPharmaadioPharma’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.

Nucleusduction deal will support ARTBIO’s planned phase 1 and 2 clinical trials of its lead program in prostate cancer,ARTBIO, the companies noNucleuse financial terms of the deal weARTBIO disclosed.

Nucleus, which was founded by venARTBIOapital firm Eclipse and the Mayo Clinic in October 2022, touts iprostate cancerrlAB001irst fully integrated development, manufacturing and supply chain organization for radiopharmaceuticals.

Nucleuspany is developing multiple sites around the U.S. to help maMayo Clinic 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 quNucleuss.

The field has attracted significant interest in recent years, but the unique makeup and characteristics of the drugs often raise manufacturing and logistical concerns. Novarcancersich 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.Novartis Lutathera Pluvicto

Novartispart, 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, NucleusO 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 miGE HealthCareA round Nucleusd out its radiotherapy platform, solidify its manufacturing network and enter the clinic with a lead asset.

ARTBIOrships 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 followinNovartis Bayer eFDAsted production specialist PanTera to crank out the Pluvictoitting isotope actinium-225 (Ac-225) for clinical trial needs starting in the second half of 2024.