Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)

Rhea-AI Summary

Radiopharm Theranostics (NASDAQ:RADX) has received FDA clearance for its Investigational New Drug (IND) application for Betabart (RV-01), a Lu177-B7H3 monoclonal antibody targeting aggressive solid tumors. The company plans to initiate its first-in-human Phase 1 clinical trial in Q4 2025.

RV-01, developed through a joint venture with MD Anderson Cancer Center, is designed with high affinity for the 4Ig isoform of B7H3, which is highly expressed in tumors but not in healthy tissues. The drug's hepatic clearance pathway and shortened half-life may offer advantages over other radiotherapeutics, potentially minimizing hematological toxicities and kidney-related side effects.

Positive

• FDA clearance received for Phase 1 clinical trial initiation
• First-in-class targeted radiopharmaceutical with unique hepatic clearance mechanism
• Strong affinity and selectivity for 4Ig isoform of B7H3, potentially improving tumor targeting
• Joint venture partnership with prestigious MD Anderson Cancer Center

Negative

• Early-stage development with no clinical data yet available
• Clinical trials not expected to begin until Q4 2025

News Market Reaction

+0.82% 2.8x vol

1 alert

+0.82% News Effect

-12.9% Trough Tracked

+$323K Valuation Impact

$40M Market Cap

2.8x Rel. Volume

On the day this news was published, RADX gained 0.82%, reflecting a mild positive market reaction. Argus tracked a trough of -12.9% from its starting point during tracking. This price movement added approximately $323K to the company's valuation, bringing the market cap to $40M at that time. Trading volume was elevated at 2.8x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3

On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25

SYDNEY, July 28, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company’s Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues.

“FDA clearance to initiate our first-in-human Phase 1 clinical trial of RV-01 represents a major milestone for Radiopharm Theranostics and our joint venture with MD Anderson Cancer Center,” said Riccardo Canevari, CEO and Managing Director. “RV-01 is the first monoclonal antibody developed through this collaboration, and we believe it has the potential to become a highly differentiated radiopharmaceutical for patients with aggressive solid tumors. We are excited to advance this program into the clinic and anticipate dosing the first patients later this year.”

“Recent reported preclinical studies demonstrated that RV-01 exhibits hepatic clearance, allowing the isotope sufficient time to effectively target tumors while potentially minimizing adverse effects such as hematological toxicities. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver—an organ known for its radio-resistance. This characteristic, combined with the shortened half-life of RV-01 and the strong affinity for the target make this agent stand out and may offer a significant advantage not just over other monoclonal antibodies but also targeted radiotherapeutics with renal excretion pathway, the latter of which are often associated with higher risk of radiopharmaceutical-induced kidney toxicity,” noted Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.

“The high affinity and selectivity of RV-01 for the 4Ig isoform of B7H3 allows the antibody to bypass the soluble 2Ig isoform in the blood, boost binding of the radiopharmaceutical to tumor targets and avoid the formation of immune complexes in circulation,” noted David Piwnica-Worms, M.D., Ph.D., Professor, MD Anderson Cancer Center, and scientific co-founder of Radiopharm Ventures.

B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is consistently correlated with enhanced tumor aggressiveness and poor clinical outcomes. Targeting the 4 Ig isoform of B7-H3 with a selective radioligand therapy may offer a novel strategy for treating refractory or high-risk tumors.

About RV-01

RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and MD Anderson Cancer Center (MDACC). RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. RV-01 has received IND-clearance from the U.S. FDA and plans to initiate a first-In-human Phase 1 study in the second half of 2025.

About Radiopharm Theranostics

Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com.

Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.

For more information:

Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com

Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com

Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au

Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/

FAQ

What is the significance of RADX's FDA IND approval for Betabart (RV-01)?

The FDA IND approval allows Radiopharm Theranostics to begin Phase 1 clinical trials for Betabart, their novel radiopharmaceutical targeting B7H3 in solid tumors, marking a significant milestone in the drug's development pathway.

How does Radiopharm's RV-01 differ from other cancer treatments?

RV-01 is unique as it's the first-in-class targeted radiopharmaceutical that specifically targets the 4Ig subtype of B7-H3, featuring hepatic clearance that may reduce toxicity compared to treatments with renal excretion.

When will RADX begin clinical trials for Betabart?

Radiopharm Theranostics plans to initiate first-in-human Phase 1 clinical trials and begin dosing patients in Q4 2025.

What types of cancer does RADX's Betabart target?

Betabart targets aggressive solid tumors that express B7-H3, an immune checkpoint molecule associated with enhanced tumor aggressiveness and poor clinical outcomes.

What is the partnership between RADX and MD Anderson Cancer Center?

Radiopharm Theranostics has a joint venture with MD Anderson Cancer Center, through which RV-01 was developed as their first monoclonal antibody collaboration.