BetaBart (RV01) / Radiopharm Theranostics - LARVOL DELTA

Radiopharm Theranostics Receives FDA Investigational New Drug Clearance for RV-01 Cancer Therapy (Small Caps) - "Radiopharm Theranostics...has received investigational new drug clearance from the US Food and Drug Administration (FDA) for therapeutic candidate Betabart (RV-01). RV-01 targets the B7H3 immune checkpoint molecule that plays a role in cancer development and progression. The FDA clearance will now allow the company to initiate a first-in-human Phase 1 clinical trial of RV-01, which it has developed in conjunction with the prestigious MD Anderson Cancer Centre at the University of Texas."

IND • New P1 trial • Oncology

Radiopharm Theranostics Reports Preclinical Lu177-B7H3-mAb Data Demonstrating Favourable Biodistribution and High Tumour Uptake (GlobeNewswire) - "Radiopharm Theranostics...announced that preclinical data from studies with the Lu177-B7H3-monoclonal antibody RV01 demonstrated favourable biodistribution and showed that RV01 maintained high tumour uptake. In addition, the Fc region modifications of the monoclonal antibody (mAb) confirm a shorter half-life, compared to traditional mAbs. The shorter half-life and other Fc modifications have the potential to limit off-target exposure to the isotope and mitigate toxicities associated with traditional monoclonal antibody therapies...These data allow us to confirm our guidance to file the IND-submission in mid-2025 and to initiate our first-in-human Phase 1 basket study by the end of this year"

IND • New P1 trial • Preclinical • Solid Tumor

ITM, Radiopharm ink Lu-177 supply agreement (AuntMinnie.com) - "ITM Isotope Technologies Munich SE (ITM) and Radiopharm Theranostics have entered into an agreement under which ITM will supply that company with non-carrier-added lutetium-177 (n.c.a. Lu-177) for Radiopharm Theranostics' radiopharmaceutical therapies pipeline. Radiopharm Theranostics will use ITM's n.c.a. Lu-177 in its development of RAD 204 (PD-L1-targeting nanobody, phase I), RAD 202 (HER2-targeting nanobody, phase I), and RV01 (B7-H3-targeting monoclonal antibody, preclinical), for the treatment of solid tumors, according to the two firms."

Licensing / partnership • Solid Tumor

Significant progress with B7-H3 targeting radio-antibody (BetaBart) (Radiopharm Theranostics Press Release) - "Radiopharm Theranostics...is pleased to announce regulatory and manufacturing progress for its B7-H3 targeting radio-antibody, BetaBart...The strong preclinical data package combined with GMP quality production, supported the pre-IND submission to the US Food and Drug Administration (FDA). Preparations are on track to prepare the IND submission with the FDA and subsequently start the Phase I/II First-In-Human (FIH) therapeutic trial with BetaBart in multiple tumour types in the US, expected for mid-2025."

IND • New P1/2 trial • Oncology • Solid Tumor

Radiopharm Theranostics (ASX:RAD) Boosts Stake to 75% in Joint Venture with MD Anderson (Kalkine Media) - "Radiopharm Theranostics Limited...has increased its stake in Radiopharm Ventures, LLC, a joint venture (JV) formed in 2022 with The University of Texas MD Anderson Cancer Center. Originally holding a 51% stake, RAD now owns 75%...The lead candidate, a B7H3 monoclonal antibody (mAb), is nearing the end of preclinical studies, with a Phase 1 therapeutic trial planned for the first half of 2025...In addition to the B7H3 candidate, RAD is advancing two other preclinical candidates with early positive results. These are approaching final candidate selection for potential use across various solid tumour types...To support these developments, RAD has committed an additional US$4.0 million to the JV. This funding will be used to cover clinical and preclinical expenses."

Financing • New P1 trial • Pipeline update • Oncology • Solid Tumor