Clinical-stage biopharmaceutical company Radiopharm Theranostics (ASX:RAD), has entered into an agreement with Radiopharm Ventures (RV) to develop and manufacture 177Lu-BetaBart, a 177Lutetium-conjugated B7-H3 targeting radioantibody.
RV is a Joint Venture between Radiopharm Theranostics (RAD) and MD Anderson Cancer Center (MDACC),
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 tumours.
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 and 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 commercialisation.”