HAMILTON, ON – In a significant step forward for precision medicine, AtomVie Global Radiopharma has successfully manufactured and supplied the first patient dose for Radiopharm Theranostics’ Phase 1/2a clinical study of 177Lu-BetaBart (RV-01).
This First-in-Human study represents a new frontier in treating aggressive solid tumors by using “smart” radioactive molecules to deliver cell-killing radiation directly to cancer cells while sparing healthy tissue.
The Science: What is 177Lu-BetaBart?
177Lu-BetaBart is a radiotherapeutic drug that combines a potent radioactive isotope, Lutetium-177, with a monoclonal antibody.
- The Target: It specifically hunts for B7-H3, an immune checkpoint molecule.
- The Problem: B7-H3 is “overexpressed” (present in high amounts) in many difficult-to-treat cancers but is rarely found in healthy cells.
- The Goal: By targeting B7-H3, the drug delivers a concentrated dose of radiation directly into the tumor, causing it to shrink.
“Dosing the first patient… represents an important milestone. We appreciate AtomVie’s manufacturing expertise as we advance BetaBart for patients with aggressive and difficult-to-treat solid tumors.” — Riccardo Canevari, CEO of Radiopharm Theranostics
About the Phase 1/2a Clinical Trial (NCT07189871)
The study is designed to evaluate safety and determine the optimal dose for future treatments. Researchers are looking for 61 participants across several cancer types, including:
- Prostate & Lung Cancer (Small cell and Non-small cell)
- Breast Cancer (Specifically Triple-Negative)
- Gastrointestinal Cancers (Colorectal and Esophageal)
- Gynecological Cancers (Ovarian, Cervical, and Endometrial)
Why This Matters for Canada
The production of radiopharmaceuticals is incredibly complex because the medicine “decays” (loses potency) over time. AtomVie’s ability to manufacture and distribute this drug from their Hamilton facility ensures that patients can access these therapies without the delays typically caused by international shipping.
AtomVie’s Growth: To meet the rising global demand for these “cancer-seeking missiles,” AtomVie is currently commissioning a massive 72,300 sq ft state-of-the-art facility, set to be fully operational by the second half of 2026.
Key Takeaways for Patients and Investors
Strategic Partnership: This drug is a product of a joint venture with the world-renowned MD Anderson Cancer Center.
Targeted Approach: Unlike traditional chemotherapy, which affects the whole body, 177Lu-BetaBart is designed to be highly specific.
Preclinical Success: Early animal studies showed significant tumor shrinkage and prolonged survival rates.
