Radiopharm Theranostics Doses First Patient in Phase 1/2a Clinical Study of BetaBart (RV-01)
MWN-AI** Summary
Radiopharm Theranostics (ASX:RAD) has reached a significant milestone by dosing the first patient in its Phase 1/2a clinical trial of 177Lu-BetaBart (RV-01), a promising radiotherapeutic agent developed in partnership with the University of Texas MD Anderson Cancer Center. This trial aims to evaluate the safety, biodistribution, radiation dosimetry, and preliminary anti-tumor efficacy of BetaBart, an innovative treatment targeting the overexpressed B7-H3 immune checkpoint molecule found in various aggressive tumors.
The Phase 1/2a trial is a dose escalation study intended to establish the recommended dose for future clinical evaluations, enrolling 61 patients with confirmed advanced solid tumors such as castrate-resistant prostate cancer, lung cancer, and triple-negative breast cancer, among others. Preclinical studies have already demonstrated that 177Lu-BetaBart can shrink tumors and prolong survival rates in treated animal models, indicating its potential effectiveness across multiple oncological indications.
Riccardo Canevari, CEO of Radiopharm Theranostics, emphasized the significance of this project as the first radiotherapeutic from the joint venture to enter clinical testing, underscoring its potential as a differentiated treatment option for patients with resistant tumors. Dr. Brandon Mancini from BAMF Health expressed pride in being part of this pioneering trial that could revolutionize treatment protocols for advanced solid tumors.
As a clinical-stage biopharmaceutical company, Radiopharm Theranostics is focused on addressing unmet medical needs through innovative cancer therapeutics. With a variety of ongoing clinical trials and a strong pipeline of unique radiopharmaceuticals, the company aims to transform cancer treatment and improve patient outcomes significantly. For more information about this trial and its developments, you can visit their website at radiopharmtheranostics.com.
MWN-AI** Analysis
Radiopharm Theranostics (ASX:RAD) recently marked an important milestone by dosing the first patient in its Phase 1/2a clinical trial for 177Lu-BetaBart (RV-01), the company’s first radiotherapeutic agent developed in conjunction with the MD Anderson Cancer Center. Given the promising preclinical data showing tumor shrinkage and prolonged survival in animal studies, investors should consider this as a significant leap forward for the company.
177Lu-BetaBart targets the B7-H3 immune checkpoint molecule, which is overexpressed in various solid tumors including prostate and breast cancer. The differentiation of BetaBart as a radiotherapeutic agent offers a novel approach in the battle against aggressive tumors, especially those resistant to conventional therapies. The trial aims to not only assess safety but also establish optimal dosing, a critical factor in determining its market viability moving forward.
From an investment standpoint, Radiopharm's current phase presents a unique opportunity. Early-phase clinical studies bear inherent risks; however, the potential upside also promises substantial rewards if BetaBart shows encouraging results. Investors should keep a close watch on subsequent updates from the clinical trial, as successful outcomes could lead to increased market confidence and a potential rise in share value.
Moreover, as the demand for innovative cancer treatments continues to grow, Radiopharm's commitment to developing a diverse pipeline of radiopharmaceuticals positions the company well within the industry. Given their other clinical trials and robust collaboration with a prestigious institute, the outlook for Radiopharm looks promising.
In conclusion, while there are risks linked with clinical trials, the strong preclinical foundation and strategic partnerships suggest that Radiopharm Theranostics could provide compelling investment opportunities in the biopharmaceutical market. Investors may want to consider taking a position, keeping an eye on trial results and market movements.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
First radiotherapeutic agent developed by Radiopharm Ventures, the joint venture between Radiopharm Theranostics and MD Anderson Cancer Center
Preclinical animal studies of BetaBart (RV-01) have demonstrated tumor shrinkage and prolonged survival
SYDNEY, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its First-In-Human (FIH) Phase 1/2a clinical trial of 177Lu-Betabart (RV-01).
The Phase 1/2a clinical trial is a dose escalation and expansion trial of 177Lu-BetaBart, designed to evaluate its safety, biodistribution and radiation dosimetry of 177Lu-BetaBart, along with its preliminary anti-tumor activity. The trial will also determine the recommended dose of 177Lu-BetaBart for future studies. This agent was developed by Radiopharm Ventures, a joint venture between Radiopharm and The University of Texas MD Anderson Cancer Center.
177Lu-Betabart is a Lu177-tagged engineered monoclonal antibody, designed with a strong affinity for the 4Ig isoform of B7-H3. 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.
“Dosing of the first patient in the Phase 1/2a trial of 177Lu-BetaBart marks an important milestone for Radiopharm, as this is the first radiotherapeutic agent from our joint venture to enter the clinic,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “177Lu-BetaBart has the potential to become a highly differentiated radiotherapeutic for patients with aggressive advanced solid tumors, and we are grateful to our collaborators and participants in this Phase 1/2a trial.”
"We are honored to administer the first dose of 177Lu-BetaBart in this Phase 1/2a clinical trial,” noted Brandon Mancini, MD, MBA, FACRO, Medical Director at BAMF Health. “As a leading center for radiopharmaceutical therapeutic trials, we appreciate the opportunity to provide this novel, first-in-class radiotherapeutic for the treatment of a variety of advanced refractory solid tumors, while offering exceptional care to our clinical trial participants.”
In preclinical studies, 177Lu-BetaBart has shown evidence of efficacy and targeting of the specific 4Ig isoform of B7-H3, supporting its potential use in multiple indications, including prostate, pancreatic, breast and other solid tumors.
About RV-01
RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and The University of Texas MD Anderson Cancer Center. 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.
About the Phase 1/2a Clinical Trial
The FIH Phase 1/2a study (NCT07189871) is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of 177Lu-Betabart (RV-01). The study aims to enroll 61 eligible participants who have a documented history of histopathologically confirmed castrate resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma.
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 four Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com.
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
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
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
FAQ**
How does Radiopharm Theranostics Limited RADX plan to expand the indication range for 177Lu-BetaBart beyond the currently targeted advanced solid tumors outlined in the Phase 1/2a trial?
What specific measures will Radiopharm Theranostics Limited RADX implement to ensure patient safety throughout the ongoing Phase 1/clinical trial of 177Lu-BetaBart?
How does the partnership between Radiopharm Theranostics Limited RADX and the MD Anderson Cancer Center enhance the development and clinical application of 177Lu-BetaBart?
What are the key milestones Radiopharm Theranostics Limited RADX anticipates achieving during the Phase 1/2a trial of 177Lu-BetaBart, and how will they impact future studies?
**MWN-AI FAQ is based on asking OpenAI questions about Radiopharm Theranostics Limited (NASDAQ: RADX).
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