#Canada #Hamilton #AtomVie #Radiopharm #BetaBart

AtomVie Global Radiopharma Achieves Milestone in Cancer Therapy

In a significant development in the field of cancer treatment, AtomVie Global Radiopharma has successfully delivered the first dose of the 177Lu-BetaBart radiopharmaceutical to a patient enrolled in the first-ever Phase 1/2a clinical study. This study is being conducted by Radiopharm Theranostics and marks a pivotal step forward in the advancement of innovative therapies aimed at combating aggressive solid tumors.

AtomVie, a top-tier Contract Development and Manufacturing Organization (CDMO) specializing in radiopharmaceuticals, has been instrumental in providing Good Manufacturing Practice (GMP) services for the production and distribution of the therapeutic drug product. The company also played a crucial role in developing and validating the radiolabeling processes and analytical methodologies necessary to facilitate the expedited filing of the Investigational New Drug (IND) application.

The objective of the Phase 1/2a clinical trial is to assess the safety, biodistribution, and radiation dosimetry of 177Lu-BetaBart, as well as its preliminary antitumor efficacy. This clinical trial is designed as a dose-escalation and expansion study, which will ultimately help establish the optimal recommended dosage for ongoing and future studies. 177Lu-BetaBart is a monoclonal antibody conjugated with 177Lutetium, specifically engineered to target the 4Ig isoform of B7-H3, a critical immune checkpoint molecule that is often overexpressed in various solid tumors.

Bruno Paquin, the Chief Executive Officer of AtomVie, stated, "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." He emphasized AtomVie’s commitment to operational excellence and reliability, as it provides support to its partners throughout the entire clinical development journey and into global commercialization.

Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics, highlighted the importance of this achievement: "Dosing the first patient in the Phase 1/2a clinical study of 177Lu-BetaBart represents an important milestone for 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."

Understanding 177Lu-BetaBart (RV-01)

177Lu-BetaBart is not just another radiopharmaceutical; it is a groundbreaking therapeutic agent developed as part of a joint venture between Radiopharm Theranostics and The University of Texas MD Anderson Cancer Center. This innovative treatment targets B7-H3, which is prevalent in various tumor types and has shown promise in shrinking tumors and extending survival in preclinical studies involving animal models.

The ongoing Phase 1/2a clinical trial, listed under NCT07189871, aspires to enroll 61 participants with confirmed diagnoses of several cancers, including castrate-resistant prostate cancer, colorectal cancer, non-small cell lung cancer, and others. This investigative study aims to gather vital data regarding the pharmacokinetics of 177Lu-BetaBart, while also shedding light on its potential role in the treatment landscape of specific solid tumors.

The Future of Radiopharmaceuticals

In a rapidly evolving therapeutic landscape, Radiopharm Theranostics aims to establish itself as a leader in developing advanced radiopharmaceuticals for diagnostic and therapeutic purposes tailored to unmet medical needs. They have crafted an impressive pipeline of technologies that differ markedly from others in the industry, including peptides, small molecules, and monoclonal antibodies targeting a range of malignancies.

With the backing of a strong clinical program encompassing multiple Phase 1 and Phase 2 trials, Radiopharm is poised to make a significant impact on the treatment of solid tumors, including those affecting the lung, breast, and other vital organs.

As AtomVie continues investing in state-of-the-art facilities, including a new facility set to commence operations in late 2026, the future looks promising for the development and commercialization of radiopharmaceuticals that can save lives and enhance patient care globally.