Cellectar reports iopofosine 83.6% ORR in WM; plans confirmatory study for accelerated approval

Cellectar Biosciences, Inc.

Iopofosine I 131 achieved 83.6% ORR and 58.2% MRR in Phase 2 CLOVER-WaM for Waldenstrom's Macroglobulinemia; primary endpoint of 20% MRR exceeded.
Company expects confirmatory randomized study (40-60 patients/arm) with FDA alignment in H1 2025; cash runway through Q4 2025.
Advancing alpha-emitting PRC CLR 121225 into Phase 1/2a solid tumor studies; IND filing expected Q1 2025.
Auger-emitting PRC CLR 121125 IND cleared; Phase 1b/2a dose finding study in triple-negative breast cancer planned.
Company pursuing partnerships for iopofosine; presentation at Biotech Showcase on Jan 14, 2025.

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