Full Press Release Details
Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)
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, Australia - 28 July 2025 - 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
"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.
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.
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
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:
CEO & Managing Director
Precision AQ (formerly Stern IR)
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Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia