Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX), a clinical-stage biopharma company specializing in radiopharmaceuticals, has announced a major milestone in the development of its novel therapeutic, 177Lu-RAD204. The company received the green light from its independent Data and Safety Monitoring Committee (DSMC) to proceed to the next dose escalation in its ongoing Phase 1 trial for patients with PD-L1-positive advanced cancers.

177Lu-RAD204 is a radiolabeled single-domain antibody (sdAb) that specifically targets PD-L1, a checkpoint protein commonly overexpressed in a wide range of aggressive tumors. The approach holds promise for overcoming immune resistance seen in standard cancer therapies.

The DSMC's positive recommendation follows their review of data from the first patient cohort, who received 30mCi of 177Lu-RAD204. Safety, pharmacokinetics, and biodistribution metrics were all deemed favorable. The next cohort will now begin at 60mCi, skipping the originally proposed 40mCi step—a testament to early signs of safety and tolerability.

The trial will now expand to include patients with NSCLC, SCLC, triple-negative breast cancer (TNBC), cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC), and endometrial cancer. With four sites in Australia actively enrolling, Radiopharm anticipates completing this next cohort by mid-2025.

"With the DSMC's support, increased site activation, and broadened cancer types, we're moving with urgency toward demonstrating 177Lu-RAD204's potential in solid tumors driven by PD-L1," said Riccardo Canevari, CEO and Managing Director of Radiopharm.

The expansion is also supported by previous success with 99Tc-RAD204, a diagnostic version of the sdAb, which showed safe and targeted imaging in NSCLC patients.

By combining targeted delivery and radiation, RAD204 exemplifies a new generation of sdAb-based theranostics—compact, precise, and powerful tools in the fight against cancer.

Source: GlobeNewswire