AtomVie Global Radiopharma and Radiopharm Ventures (RV) are collaborating to develop and manufacture 177Lu-BetaBart, a 177Lutetium-conjugated radioantibody targeting the B7-H3 immune checkpoint molecule, which is overexpressed in various tumor types. This partnership aims to advance the novel radiopharmaceutical through clinical trials, with a Phase I study expected to commence in mid-2025.
Targeting B7-H3 for Cancer Therapy
The B7-H3 molecule has been identified as a promising target due to its involvement in tumor cell proliferation, metastasis, and therapeutic resistance. According to research published in Molecular Cancer Journal, B7-H3 plays a significant role in cancer progression, making it an attractive target for therapeutic intervention. 177Lu-BetaBart is designed to target the 4Ig subtype of B7-H3, representing a novel approach in radiopharmaceutical therapy.
Manufacturing and Production
AtomVie will produce 177Lu-BetaBart for upcoming US clinical trials. The monoclonal antibody (mAb) component of 177Lu-BetaBart was engineered at MD Anderson Cancer Center (MDACC) to exhibit a short blood circulation time and reduced affinity for on-target off-tissue toxicity, enhancing its suitability for human trials. Production will initially take place at McMaster University in Hamilton, Ontario, Canada, where AtomVie has been producing therapeutics for approximately ten years. Subsequently, production will transition to AtomVie's new Hamilton facility, expected to be operational by March 2025.
Clinical Trial Preparations
AtomVie plans to scale up the manufacturing process based on the clinical trial phase. Initial Phase I batches will consist of one to two doses, with Phase II potentially involving five doses per batch. Phase III production could reach up to 30 doses per batch, contingent on the specific process requirements. Key considerations in manufacturing include fine-tuning the formulation to achieve optimal yield and stability, as well as addressing logistical challenges related to shipping temperature, quality control, and the short shelf life of radiopharmaceuticals.
Expert Perspectives
"We are thrilled to partner with RAD on such an important project," said Bruno Paquin, CEO of AtomVie. "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."
Riccardo Canevari, managing director and CEO of RAD, added, "Our collaboration with AtomVie is a significant step forward in our mission to bring innovative radiopharmaceutical therapies to patients. 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."
