Radiopharm (ASX: RAD) Advances 177Lu-RAD204 to Higher Dose in Phase 1 Trial

May 12, 2025 01:17 PM AEST | By Aditi Sarkar

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Radiopharm (ASX: RAD) Advances 177Lu-RAD204 to Higher Dose in Phase 1 Trial — Image source: Company update

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Highlights

Radiopharm shares rose ~5% to AUD 0.022 following a key clinical trial milestone.

The DSMC approved dose escalation in the Phase 1 trial of 177Lu-RAD204 for PD-L1-positive cancers.

Early data from the first cohort showed favorable safety, pharmacokinetics, and biodistribution.

The next cohort will receive a higher dose of 60mCi, up from the initially planned 40mCi.

Trial expansion will target multiple PD-L1-expressing cancers, including NSCLC, TNBC, and melanoma.

Four Australian clinical sites are actively screening and enrolling patients for the study.

Shares of Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX), a clinical-stage biopharmaceutical company, jumped by approximately 5% to AUD 0.022 during early trading hours on Monday. The rally followed the announcement of a significant milestone for the company’s clinical-stage radiotherapeutic candidate, 177Lu-RAD204.

Radiopharm has received approval from the Data and Safety Monitoring Committee (DSMC) to progress to the next dosing level in its ongoing Phase 1 clinical trial targeting patients with PD-L1-positive advanced cancers. This approval enables Radiopharm to advance to a higher dose cohort across a range of PD-L1-driven tumor types. The DSMC has reviewed the first patient cohort, which received 30mCi of 177Lu-RAD204. The next patient cohort will proceed with a higher dose of 60mCi of 177Lu-RAD204, an increase from the initially planned 40mCi.

Reflecting on the development, Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics said, “With this clearance from the DSMC, the increased number of active centers and expansion to multiple tumor types beyond Non-Small Cell Lung Cancer (NSCLC), we expect to accelerate our timelines for complete enrolment of the next cohort by mid-2025. We believe that RAD204 has the potential to strongly improve clinical outcomes for patients with PD-L1 positive advanced cancers, and we look forward to seeing data from the first two cohorts of patients later this year”.

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