Siemens Healthineers partnership seeks to boost supply of novel PET imaging agent
A new Siemens Healthineers partnership seeks to bolster the supply of a novel imaging agent that recently earned Fast Track designation from the FDA
The imaging manufacturer is partnering with Radiopharm Theranostics, a Sydney, Australia-based biopharmaceutical firm focused on creating new products to address unmet medical needs. Under the agreement, Siemens will both manufacture and distribute doses of RAD101, supporting an upcoming Phase 3 trial in the U.S.
Radiopharm Theranostics’ new imaging small molecule is radiolabeled with Fluorine-18 and targeted for the diagnosis of suspected recurrent brain cancer that has metastasized.
“With our large national network of radiopharmacies in the U.S., we are uniquely qualified and well-equipped to deliver RAD101 as well as other novel PET biomarkers to assist in the fight against challenging diseases…,” Barry Scott, head of radiopharma at Siemens Healthineers, said in a statement April 7, estimating the drug addresses a potential market of over 300,000 individuals in the U.S. each year.
The U.S. Food and Drug Administration previously granted its Fast Track designation to RAD101 last June, expediting the review of new drugs meant to treat serious conditions. Positive data from early Phase 2 trials in patients with brain metastases showed significant tumor uptake, Radiopharm Theranostics reported previously. The study further indicated that PET-MRI may potentially represent a noninvasive method of predicting overall survival, “warranting larger studies.”
The Australian company also is publicly traded on the Nasdaq (RADX) and has a pipeline of other potential products aimed at diagnosing and treating cancer. Experts noted that a second interim analysis showed 90% (18/20) of patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary endpoint). Imaging confirmed metabolic activity in brain metastases compared to equivalent MRI findings. Plus, data from the first five patients at six-month follow-up showed positive trends for both sensitivity and specificity (a secondary endpoint).
“This partnership marks a milestone for Radiopharm, as we bring RAD101 closer to improving diagnostic precision for brain metastases,” Riccardo Canevari, CEO and managing director of Radiopharm Theranostics, said in a statement.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.