AtomVie Global Radiopharma and Radiopharm Theranostics Partner to Develop and Manufacture 177Lu-BetaBart Radioantibody for Treatment of Multiple Solid Tumors

HAMILTON, ON, Oct. 16, 2024 /PRNewswire/ -- AtomVie Global Radiopharma (AtomVie), a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), has entered into an agreement with Radiopharm Ventures (RV), a Joint Venture between Radiopharm Theranostics (RAD) and MD Anderson Cancer Center (MDACC), to develop and manufacture ¹⁷⁷Lu-BetaBart, a 177Lutetium-conjugated B7-H3 targeting radioantibody. This partnership leverages both companies' expertise to advance novel radiotherapeutic solutions in areas of high unmet medical needs.

B7-H3 is an immune checkpoint molecule that is overexpressed in several tumor types and represents a highly attractive target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is linked with tumor aggressiveness and poor outcomes. ¹⁷⁷Lu-BetaBart is the first targeted radiopharmaceutical in development against the 4Ig subtype of B7-H3, which is the most common subtype expressed on human tumors. The monoclonal antibody, invented at MDACC, has been specifically engineered with a shorter blood circulation time and reduced affinity for on-target off-tissue toxicity, leading to a final molecule that is highly promising for human use in clinical settings. Phase I/II First-In-Human therapeutic trial with ¹⁷⁷Lu-BetaBart in multiple tumor types in the US, is expected for mid-2025

This collaboration brings together RAD's world-class platform of radiotherapeutic products and AtomVie's leading in manufacturing and distributing radiopharmaceuticals globally. ¹⁷⁷Lu-BetaBart is part of a broader pipeline of distinct, highly differentiated technologies developed by RAD and RV. These span peptides, small molecules, and monoclonal antibodies for use in cancer, sourced from top-tier universities and institutes globally. The pipeline is designed with the strong potential to be either first-to-market or best-in-class.

AtomVie's extensive expertise in clinical development, including technology transfer, process and method development, clinical supply and global distribution, provides a reliable foundation for advancing ¹⁷⁷Lu-BetaBart from the clinic towards commercialization. With its new state-of-the-art, scalable 72,300 sq ft facility, set to open in early 2025, AtomVie is the partner of choice to support the growing global pipeline of radiotherapeutics.

"Our collaboration with AtomVie is a significant step forward in our mission to bring innovative radiopharmaceutical therapies to patients," said Riccardo Canevari, Managing Director & CEO of RAD. "Their proven track record in manufacturing and global distribution assures us that we are in capable hands as we progress through the clinical stages and prepare for potential commercialization."

Bruno Paquin, CEO of AtomVie, commented, "We are thrilled to partner with RAD on such an important project. With our expertise in radiopharmaceutical manufacturing, we are confident that we can support RAD in advancing their innovative pipeline. This partnership reinforces our commitment to transforming patients' lives with high-quality radiopharmaceuticals, as we continue to expand our capabilities in our new facility and empower novel radiotherapeutics to market."

About AtomVie Global Radiopharma Inc. (AtomVie)

AtomVie is a global leading CDMO for the GMP manufacturing and worldwide distribution of clinical and commercial radiopharmaceuticals. AtomVie offers the full range of scientific, technical, regulatory, quality, logistics, and business expertise combined with a specialized infrastructure for the development of radiopharmaceuticals from clinical studies to the commercial marketplace. AtomVie currently serves international clients conducting studies in over 25 countries worldwide. For more information, visit https://www.atomvie.com/

About Radiopharm Theranostics (RAD) and Radiopharm Ventures (RV)

RAD is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need. RAD has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules, and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world's leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. RV is a Joint Venture between RAD and MDACC. Radiopharm Ventures brings together MDACC's proprietary technologies in antigen discover and molecular imaging, with RAD's expertise in developing radiopharmaceuticals. Learn more at https://www.radiopharmtheranostics.com/

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SOURCE AtomVie Global Radiopharma Inc.