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Highlights
- Radiopharm has secured IND approval from the US FDA for its αVβ6 Integrin (RAD301) technology.
- The IND approval enables the company to commence a Phase 1 imaging trial at the end of Q1 CY23.
- The company believes that the technology will deliver an encouraging result that RAD can push toward commercialisation.
Shares of Radiopharm Theranostics (ASX:RAD) are rallying on the ASX today with an uptick of around 5%. The trigger in the share price followed a company update regarding Investigational New Drug application (IND) approval for its αVβ6 Integrin (RAD301) technology.
Following the IND approval from the US Food and Drug Administration (FDA), Radiopharm can now commence a Phase 1 imaging trial. The Phase 1 trial on ambulatory patients with pancreatic cancer is targeted to start at the end of Q1 CY23 with an anticipated completion by Q3 CY23. To date, imaging options for pancreatic cancer have several limitations, and it presents a high unmet medical need.
Data and image source: Company update, © 2022 Kalkine Media®
Clinical site preparation underway
In August 2021, Radiopharm entered an exclusive licence agreement with TRIMT GmbH to develop radiopharmaceuticals, including Ga68-Integrin (RAD301). RAD301 technology has already delivered substantial clinical data from 88 patients dosed to date in several geographies. Radiopharm is now progressing with clinical site preparation for the trial. The company expects to dose the first subject at Montefiore Einstein Cancer Center (MECC) in New York.
Data source: Company update, Image source: © Katerynakon | Megapixl.com, © 2022 Kalkine Media®
Earlier this month, Radiopharm announced the publication of positive imaging data of its HER2 nanobody (RAD201) in the reputed European Journal of Nuclear Medicine & Molecular Imaging. The publication highlighted RAD201 as a promising non-invasive tool for differentiating HER2 status in metastatic (breast) cancer, irrespective of continuing HER2-targeted antibody treatment.
RAD shares were trading at AU$0.105 midday on 30 December 2022.