Radiopharm Theranostics (ASX:RAD) Advances Promising Radiotherapy Drug Toward Trials

October 03, 2024 11:26 AM AEST | By Sonal Goyal

Radiopharm Theranostics (ASX:RAD) Advances Promising Radiotherapy Drug Toward Trials — Image source: Company update

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Highlights

RAD is making significant regulatory and manufacturing progress with BetaBart, its B7-H3 targeting radio-antibody.

Preclinical data, combined with GMP-quality production, supported the pre-IND submission to the U.S. Food and Drug Administration (FDA).

Phase I/II First-In-Human (FIH) therapeutic trial with BetaBart, targeting multiple tumor types in the U.S., is expected to start by mid-2025.

BetaBart will be used in the planned clinical trial as a 177 Lutetium-conjugated therapeutic.

Radiopharm Theranostics Limited (ASX:RAD) has announced a significant update regarding the regulatory and manufacturing progress of its B7-H3 targeting radio-antibody, BetaBart. Supported by promising preclinical data and high-quality GMP production, the company has successfully completed its pre-IND submission to the U.S. FDA.

Preparations are well underway to submit the IND application to the FDA and begin the Phase I/II First-In-Human (FIH) trial for BetaBart, which aims to target multiple tumor types in the U.S. This trial is anticipated to start by mid-2025.

RAD shares jump

RAD shares jumped 3.57% to trade at AU$0.029 apiece at the time of writing on 3 October 2024.

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