AtomVie Global Radiopharma (AtomVie), a global leading radiopharmaceutical CDMO, announced that it has supplied the successful dosing of the first patient in Radiopharm Theranostics' First-in-Human Phase 1/2a clinical study of 177Lu‑BetaBart (RV‑01) by providing GMP manufacturing and distribution services for the radiotherapeutic drug product, after successfully developing and qualifying the radiolabeling process and analytical methods using a phase-appropriate approach that expedited IND filing.

The Phase 1/2a clinical study is designed as a dose-escalation and expansion trial evaluating the safety, biodistribution, radiation dosimetry, and preliminary anti-tumor activity of 177Lu‑BetaBart, while also determining the recommended dose for future studies. 177Lu-BetaBart (RV‑01) is a 177Lutetium‑conjugated monoclonal antibody engineered to target the 4Ig isoform of B7‑H3, an immune checkpoint molecule overexpressed across multiple solid tumor types.

"Enabling the first patient dose of 177Lu-BetaBart reflects what matters most to us, ensuring that high‑quality radiopharmaceuticals are manufactured, released, and delivered on time so patients can access innovative therapies without delay," said Bruno Paquin, Chief Executive Officer of AtomVie. "Our team is deeply focused on operational excellence and reliability, supporting our partners from early clinical development through global supply."

"Dosing the first patient in the Phase 1/2a clinical study of 177Lu‑BetaBart represents an important milestone for Radiopharm Theranostics," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We appreciate AtomVie's manufacturing expertise and commitment to quality as we advance BetaBart for patients with aggressive and difficult‑to‑treat solid tumors."