U.S. Food and Drug Administration grants Investigational New Drug authorization to Radiopharm Theranostics, allowing them to initiate a Phase I therapeutic clinical trial, focusing on the bekitzumab (B7H3) targeted treatment using Betabart.
Radiopharm Theranostics, a clinical stage radiotherapeutics company listed on ASX (RAD) and NASDAQ (RADX), has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for RV-01, also known as Betabart. This clearance paves the way for the initiation of a first-in-human Phase 1 clinical trial planned to start in the fourth quarter of 2025.
RV-01 is a monoclonal antibody therapeutic targeting the immune checkpoint molecule B7H3, which is highly expressed in aggressive solid tumors. The radiotherapeutic agent is designed to deliver targeted radiation via its strong affinity for B7H3, playing a significant role in tumor development and progression.
Preclinical studies have demonstrated tumor shrinkage and prolonged survival in animal models, indicating promising antitumor activity. One of the key advantages of RV-01 is its liver clearance, in contrast to renal clearance common in other radiotherapeutics, and its shortened half-life. These factors may offer advantages by reducing radiation damage to non-target tissues and improving treatment tolerability.
RV-01 is a radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, a joint venture between Radiopharm Theranostics and MD Anderson Cancer Center. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain.
Financially, Radiopharm Theranostics is well-positioned with over $29 million in cash as of mid-2025, supporting multiple early-phase clinical trials, including the RV-01 program. The company views RV-01 as a key part of its expanding radiopharmaceutical pipeline for hard-to-treat cancers.
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. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver—an organ known for its radio-resistance.
For investor inquiries, contact Riccardo Canevari, CEO & Managing Director at +1 862 309 0293 or [email protected]. For media inquiries, contact Matt Wright at +61 451 896 420 or [email protected]. To learn more about Radiopharm Theranostics, visit their website at https://radiopharmtheranostics.com/. You can also connect with the company on LinkedIn at https://www.linkedin.com/company/radiopharm-theranostics/ or InvestorHub at https://investorhub.radiopharmtheranostics.com/.
[1] GlobeNewswire via QuoteMedia [2] Radiopharm Theranostics Limited 2025 Annual Report [3] MD Anderson Cancer Center News Release [4] ClinicalTrials.gov Identifier: NCT05609118
- The upcoming clinical trial for RV-01, a radiotherapeutic agent designed totarget aggressive solid tumors, is significant in the field of health-and-wellness, as it may offer improved treatment tolerability and reduced radiation damage to non-target tissues.
- In the realm of finance, Radiopharm Theranostics, a company focused on developing radiopharmaceutical therapeutics for hard-to-treat cancers, boasts a strong financial position with over $29 million in cash, supporting multiple early-phase clinical trials.
- The potential medical-conditions applications of RV-01 extend beyond lung, breast, and brain cancers, as its high affinity for the 4Ig isoform of B7H3 allows it to bypass soluble isoforms in the blood and bind effectively to tumor targets, a significant advancement in the science and technology of cancer treatment.
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