Radiopharm Theranostics Limited (RADX), Monday announced pre-clinical data from studies with the Lu177-B7H3-monoclonal antibody RV01, a radiopharmaceutical therapy, which is being developed in partnership with MD Anderson Cancer Center.
The data demonstrated favourable biodistribution and showed that RV01 maintained high tumour uptake.
Chief Medical Officer Dimitris Voliotis stated that the pre-clinical data further validates earlier preclinical work that showed strong affinity to the target without the extensive circulation time of other monoclonal antibodies.
The biodistribution study is the last pre-clinical work needed to complete the pre-clinical package for submission of Investigational New Drug Application with the U.S. Food and Drug Administration in mid-2025, the company noted.
Moreover, Radiopharm intends to initiate first-in-human Phase 1 basket study in the fourth quarter of 2025.
Currently, RADX is trading at $5.16, up 7.76 percent on the Nasdaq.
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