#USA #Hamilton #AtomVie #Radiopharm #177Lu-BetaBart

AtomVie Global Radiopharma Supplies First Patient Dose in Clinical Study of 177Lu-BetaBart

In a significant step forward for cancer treatment, AtomVie Global Radiopharma, a leading global contract development and manufacturing organization (CDMO) in the radiopharmaceutical sector, has successfully administered the first dose to a patient participating in the Phase 1/2a clinical study of 177Lu-BetaBart (RV-01). This initiative marks a crucial milestone within the innovative field of targeted cancer therapies.

Overview of the Study and Product

The ongoing Phase 1/2a clinical trial aims to assess the safety, biodistribution, radiation dosimetry, and preliminary anti-tumor activity of 177Lu-BetaBart. Utilizing a monoclonal antibody conjugated with lutetium, the treatment specifically targets the 4Ig isoform of B7-H3, an immune checkpoint molecule known to be overexpressed in various solid tumors. The study serves to evaluate optimized dosage to guide future research.

Bruno Paquin, the CEO of AtomVie, expressed pride in this achievement, noting that it is pivotal for ensuring that high-quality radiopharmaceutical products are developed and delivered in a timely manner. His statement underscores the company's commitment to operational excellence and its role in supporting partners throughout the clinical development stages and global supply chain.

Riccardo Canevari, CEO of Radiopharm Theranostics, also highlighted the importance of this milestone, recognizing AtomVie’s expertise in manufacturing and quality assurance. As they progress BetaBart to treat patients with aggressive and hard-to-treat solid tumors, collaboration remains a vital factor.

About BetaBart (RV-01)

BetaBart, known scientifically as RV-01, is distinguished as the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, a partnership between Radiopharm Theranostics and the MD Anderson Cancer Center from the University of Texas. Initial preclinical studies with BetaBart have demonstrated significant reductions in tumor size and increased survivability in treated animals, showcasing the therapy’s potential effectiveness.

Clinical Trial Details

This First-in-Human (FIH) trial is designed to gather information on the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of 177Lu-BetaBart. The study is set to enroll 61 eligible participants with documented histories of various cancers, including castration-resistant prostate cancer, colorectal cancer, and non-small cell lung cancer, among others. Each participant's eligibility is confirmed through histopathological examination.

About Radiopharm Theranostics

Radiopharm Theranostics operates within the field of radiotherapy, developing innovative radiopharmaceutical products that meet unfulfilled medical needs, particularly in diagnostics and therapeutic applications. The company is publicly listed on both the ASX and NASDAQ under the ticker symbols RAD and RADX, respectively. Its diverse portfolio covers advanced technologies encompassing peptides, small molecules, and monoclonal antibodies tailored for cancer treatment. The clinical program currently involves multiple Phase 1 and Phase 2 trials across various solid tumor types, showing promising applications for lung and breast cancers, as well as brain metastases.

For further information regarding Radiopharm Theranostics, please visit their website at radiopharmtheranostics.com.

About AtomVie

AtomVie is recognized as a premier CDMO specializing in Good Manufacturing Practices (GMP) for the clinical and commercial supply of radiopharmaceuticals. Offering comprehensive scientific, technical, regulatory, logistical, and quality assurance services, AtomVie supports the entire pipeline from clinical trials (Phases I to III) to commercial market entry. The organization currently caters to international clients engaged in clinical trials across over 28 countries worldwide. Furthermore, AtomVie is set to enhance its capabilities with a state-of-the-art 72,300-square-foot facility expected to become operational in the second half of 2026.

For inquiries about AtomVie, contact Tina Chainani, Business Development Manager, at +1 437 239 1288 or via email at [email protected].