- AtomVie Global Radiopharma supplied the first patient dose in Radiopharm Theranostics’ Phase 1/2a clinical study of 177Lu-BetaBart (RV-01).
- The company provided GMP manufacturing and distribution services and supported radiolabeling process development and IND-enabling activities.
AtomVie Global Radiopharma, a radiopharmaceutical contract development and manufacturing organization (CDMO), announced that it has supplied the first patient dose in Radiopharm Theranostics’ First-in-Human Phase 1/2a clinical study of 177Lu-BetaBart (RV-01). AtomVie provided GMP manufacturing and distribution services for the radiotherapeutic drug product after developing and qualifying the radiolabeling process and analytical methods using a phase-appropriate approach that supported expedited IND filing.
The Phase 1/2a study is structured as a dose-escalation and expansion trial. It is evaluating the safety, biodistribution, radiation dosimetry, and preliminary anti-tumor activity of 177Lu-BetaBart, as well as determining a recommended dose for future studies. The trial aims to enroll 61 participants across multiple solid tumor indications, including castrate resistant prostate cancer, colorectal cancer, lung cancers, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer, and esophageal squamous cell carcinoma.
“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.”
Bruno Paquin, Chief Executive Officer of AtomVie
177Lu-BetaBart 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. Radiopharm Ventures, a joint venture between Radiopharm Theranostics and The University of Texas MD Anderson Cancer Center, are developing the therapeutic. AtomVie stated that its integrated development and GMP contract manufacturing services are designed to support partners from early clinical development through global supply.
