Bookended by its first commercial-scale manufacturing of the radioisotope actinium-225 in January and an expected high-capacity production line launch by the end of the year, radiopharmaceutical supplier and CDMO NorthStar Medical Technologies has secured a hefty chunk of change to pave the way for long-term success.
On Tuesday, NorthStar—based in Beloit, Wisconsin, and serving a global customer base of nuclear medicine players—announced a multi-year growth capital facility worth up to $185 million from Hercules Capital. Of that sum, $100 million is being delivered upfront to hasten investments in isotope production and clinical manufacturing, NorthStar said in a release.
NorthStar already boasts a Rolodex of clients that includes “several of the largest companies developing Ac-225 therapies.”
With the early success of Novartis’ lutetium-177-based radiopharmaceutical Pluvicto, the Swiss drugmakers and others in the radiopharmaceutical business have increasingly turned to actinium-225, or Ac-225, as a promising isotope for next-generation therapies, due in part to its alpha-emitting properties and preferable half life constraints.
Bottlenecks around the isotope have posed problems for developers in recent years, though efforts have been made by drugmakers and suppliers alike to stabilize the supply chain. NorthStar believes its own production undertakings are helping to even out the landscape, too, the company’s president and CEO, Frank Scholz, Ph.D., told Fierce.
Northstar is ultimately hoping to carve out a leader’s position in the radiopharmaceutical field by “integrating the supply chain” through the co-location of actinium production and CDMO services on the same campus, said Scholz in an interview.
At present, this setup at the company’s site in Beloit is unique among radiopharmaceutical players in the United States, offering significant efficiency boons for customers, Scholz said.
With the new funding vehicle, meanwhile, Scholz revealed that NorthStar will further build out its CDMO capabilities. The company currently boasts three buildings at its Beloit site, with plans to now add additional suites for early-stage, late-stage and commercial contract manufacturing demand. At the same time, the funds will help bolster Northstar’s actinium production efforts, too.
As for the unique benefits the co-location of Northstar’s isotope production and CDMO services provide, Scholz noted that “radioisotopes are like a melting ice cube: The longer any step in the process takes, the more of the material decays.”
Actinium-225 has a specific half-life of approximately 10 days, “and that means the shorter the production process is, the better with regards to the material you keep,” Scholz explained.
“If you have it on the same campus,” he added, “you are the fastest relative to everybody else.”
Apart from actinium-225, Northstar is also actively producing copper-67.
The company currently boasts more than 30 customers, spanning isotope supply and CDMO services, with many clients employing Northstar for both, according to Scholz. Meanwhile, the company can also conduct contracting work that revolves around isotopes it doesn’t produce itself, such as lutetium-177 or copper-64, the CEO added.
This work runs the gamut from therapeutics to diagnostics, with Northstar’s customer base incorporating a mix of small biotechs to big pharmas across North America, Asia, Australia and Europe.
The cash infusion comes amid a banner year for NorthStar, which in January became the first company to produce commercial-scale, no-carrier-added Ac-225 using electron accelerator technology.
This announcement dovetailed with an expansion of the company’s pact with Convergent Therapeutics to support both late-stage studies and potential commercial demand for the biotech’s experimental radiopharmaceutical for metastatic castration-resistant prostate cancer, CONV01-α.
Added to that, NorthStar is planning to transition its campus in Beloit to the use of a high-capacity production line for n.c.a Ac-225 before the year is out.