Radiopharm Secures FDA Nod to Launch First-in-Human Trial of RV-01 Targeting Aggressive Tumors
Radiopharm Theranostics has received FDA clearance to begin a Phase I clinical trial for RV-01, a novel radiopharmaceutical targeting the 4Ig isoform of B7-H3 in solid tumors, marking a significant step forward in cancer treatment innovation.
- FDA grants IND approval for RV-01 Phase I trial
- RV-01 targets 4Ig isoform of B7-H3, highly expressed in tumors
- First-in-human study planned for Q4 2025
- Collaboration with MD Anderson Cancer Center
- Potential safety advantage due to hepatic clearance
FDA Clearance Marks a Milestone for Radiopharm Theranostics
Radiopharm Theranostics, a clinical-stage biopharmaceutical company listed on both the ASX and Nasdaq, has announced a pivotal regulatory achievement – the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for RV-01. This clearance authorizes the company to initiate a first-in-human Phase I clinical trial targeting solid tumors with their innovative radiopharmaceutical, Betabart (RV-01).
A Novel Approach Targeting B7-H3 in Solid Tumors
RV-01 is a Lu177-conjugated monoclonal antibody designed to selectively bind the 4Ig isoform of B7-H3, an immune checkpoint molecule overexpressed in multiple aggressive tumor types but minimally present in healthy tissues. This selective targeting is critical because deregulated B7-H3 expression correlates with tumor aggressiveness and poor patient outcomes, making it a compelling therapeutic target.
Unlike many radiopharmaceuticals cleared through renal pathways, RV-01 is primarily cleared by the liver, an organ known for its radio-resistance. This hepatic clearance potentially reduces the risk of kidney toxicity, a common concern with other radiotherapeutics. Additionally, the antibody’s strong affinity and selectivity allow it to bypass soluble forms of B7-H3 in circulation, enhancing tumor targeting and minimizing immune complex formation.
Collaboration with MD Anderson Cancer Center
RV-01 is the first therapeutic agent developed through Radiopharm’s joint venture with the MD Anderson Cancer Center, a world-renowned oncology research institution. This partnership underscores the scientific rigor behind the program and the potential for RV-01 to become a differentiated treatment option for patients with refractory or high-risk solid tumors.
Looking Ahead to Clinical Trials
The company plans to commence dosing in the Phase I trial in the fourth quarter of 2025. Preclinical studies have demonstrated promising results, including tumor shrinkage and prolonged survival in animal models, setting a hopeful tone for the upcoming human trials. The Phase I study will primarily assess safety, dosing, and early signs of efficacy, laying the groundwork for subsequent clinical development stages.
Radiopharm’s CEO, Riccardo Canevari, emphasized the significance of this milestone, highlighting the potential of RV-01 to address unmet medical needs in oncology. Meanwhile, the company’s Chief Medical Officer noted the unique pharmacokinetic profile of RV-01 as a potential advantage over existing radiotherapeutics.
Bottom Line?
As Radiopharm prepares to translate promising preclinical data into clinical reality, the oncology community will be watching closely for RV-01’s impact on treating aggressive solid tumors.
Questions in the middle?
- How will RV-01’s safety profile compare to existing radiopharmaceuticals in human patients?
- What specific tumor types will be prioritized in the Phase I trial enrollment?
- How might RV-01’s hepatic clearance influence dosing schedules and patient tolerability?
