#USA #Hamilton #AtomVie #Radiopharm Theranostics #BetaBart

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

On February 24, 2026, AtomVie Global Radiopharma, a leading global radio-pharmaceutical CDMO, achieved a major milestone by supplying the first successful dose to a patient in the Phase 1/2a clinical trial of Radiopharm Theranostics’ 177Lu-BetaBart (RV-01). This significant advancement in cancer treatment highlights AtomVie’s commitment to providing high-quality radiopharmaceuticals promptly for innovative therapies.

Bruno Paquin, CEO of AtomVie, expressed the importance of this achievement, stating, "Administering the first dose of 177Lu-BetaBart to patients underscores our primary focus on ensuring the timely manufacture, launch, and delivery of high-quality radio-pharmaceuticals, facilitating patient access to groundbreaking therapies without unnecessary delays. Our team is dedicated to operational excellence and reliability, supporting our partners from initial clinical development through global supply."

The Phase 1/2a clinical study is designed as a dose-escalation and expansion trial to evaluate the safety, biodistribution, radiation dosimetry, and preliminary anti-tumor activity of the 177Lu-BetaBart, with the aim of recommending a suitable dose for future studies. 177Lu-BetaBart (RV-01) is a monoclonal antibody conjugated with Lutetium-177, targeting the isoform 4Ig of B7-H3, a checkpoint molecule over-expressed in various solid tumor types.

Riccardo Canevari, CEO of Radiopharm Theranostics, noted the significance of the first patient dose in the Phase 1/2a study, saying, "The administration of BetaBart to the first patient represents a critical milestone for Radiopharm Theranostics. We appreciate AtomVie’s manufacturing expertise and commitment to quality as we develop BetaBart for patients with aggressive and hard-to-treat solid tumors."

About BetaBart (RV-01)

RV-01 is the first therapeutic radio-pharmaceutical agent developed by Radiopharm Ventures, a joint venture formed between Radiopharm Theranostics and the MD Anderson Cancer Center at the University of Texas. 177Lu-BetaBart is a therapeutic agent conjugated with Lutetium-177 that acts on B7-H3, an immune checkpoint molecule over-expressed in several tumor types. Preclinical studies with BetaBart have shown significant tumor reduction and improved survival rates in animals treated with this radiotherapeutic agent.

Phase 1/2a Clinical Trial Details

The First-In-Human (FIH) Phase 1/2a trial (NCT07189871) is structured to determine the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of 177Lu-BetaBart. The study plans to enroll 61 eligible participants with documented histories of various cancer types including prostate cancer resistant to castration, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, ovarian cancer, cervical cancer, endometrial cancer, triple-negative breast cancer, and squamous cell carcinoma of the esophagus, all histopathologically confirmed.

About Radiopharm Theranostics

Radiopharm Theranostics is a clinical-stage radiotherapy company focused on developing a leading pipeline of innovative radio-pharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. The company is publicly traded on the Australian Securities Exchange (RAD) and NASDAQ (RADX), offering a unique portfolio of differentiated platform technologies including peptides, small molecules, and monoclonal antibodies for cancer use. Their clinical program encompasses a Phase 2 trial and three Phase 1 trials across various types of solid tumors, including lung, breast, and brain metastases. For more information, visit radiopharmtheranostics.com.

About AtomVie Global Radiopharma

AtomVie is a world leader in the manufacturing and global distribution of GMP-compliant clinical and commercial radiopharmaceuticals. AtomVie provides a comprehensive range of scientific, technical, regulatory, quality, and logistical services, alongside specialized infrastructure for the development of radiopharmaceuticals from Phase I-III clinical studies to commercialization. AtomVie currently supports international clients conducting clinical studies in over 28 countries. The company is set to develop and commission new state-of-the-art facilities spanning 6,600 square meters, specifically designed for this purpose, expected to be operational in the second half of 2026. For more information, visit atomvie.com.