Iopofosine I-131: Beta Emitter

About Iopofosine I 131: Beta Emitter

Iopofosine I-131 is Cellectar’s lead investigational Phospholipid Drug Conjugate (PDC)™ radiotherapeutic, designed to deliver iodine-131 directly to tumor cells while minimizing exposure to healthy tissue.

Iopofosine I-131 has been evaluated in the completed CLOVER-WaM Phase 2 pivotal study for patients with relapsed or refractory Waldenström macroglobulinemia (WM) and continues to be studied in a Phase 2b trial in relapsed or refractory multiple myeloma and CNS lymphoma, as well as the CLOVER-2 Phase 1b study in pediatric patients with high-grade glioma.

FDA Regulatory and
European Achievements

Cellectar has received multiple regulatory designations in both the United States and Europe for Iopofosine I-131, reflecting its potential to address serious and rare diseases across hematologic malignancies and pediatric cancers. These designations do not imply approval or established efficacy.

Indication United States FDA European EMA
Breakthrough Therapy Designation Orphan Drug Designation Fast Track Designation Rare Pediatric Disease Designation PRIME Designation Orphan Drug Designation
Adult Waldenström Macroglobulinemia completed completed completed completed completed
Multiple Myeloma completed completed completed
Diffuse large b-cell lymphoma completed
Pediatric Ewing’s Sarcoma completed completed
Neuroblastoma completed completed
Osteosarcoma completed completed
Rhabdomyosarcoma completed completed

Waldenstrom macroglobulinemia U.S. Market Size

Upon potential FDA approval, iopofosine a novel, targeted radiotherapeutic may provide a meaningful treatment option for relapsed and/or refractory patients.

approximately ~11,500

Relapsed refractory patients 1

approximately ~4,700

3rd-line or greater patients1

approximately ~1,000

Patients exhausting treatment options by the 3rd-line1

Later-Line Patients Have High Unmet Need

approximately ~80%

Of patients will receive 3rd-line treatment 2

approximately ~50%

Of patients are retreated with the same or similar treatment from prior lines of therapy3

>60%

Of therapies utilized are not FDA-approved and cannot be promoted4

Patients are Concentrated Geographically
in Large Community and Academic Accounts5

~80%
Of WM patients reside in 15 states3

No Established Standard of Care
Across All Lines of Therapy

Market Shares by Line of Therapy4

Year Other BCL-2 BTKi + Rituximab BTKi Mono Rituximab Mono Bendamustine +/- Rituximab
1st Line 12% -- 3% 22% 28% 35%
1st Line 13% 1% 3% 29% 40% 14%
3rd Line 17% 1% 4% 32% 36% 11%
4th Line + 18% 4% 4% 32% 35% 8%

  1. Internal claims analysis for Waldenström’s macroglobulinemia (January 2019–October 2023).

  2. Putnam Market Sizing 2023.

  3. Putnam Quantitative Research 1Q 2023 (n=102 MDs); Putnam Analysis and WM Advisory Boards.

  4. Komodo Claims Data.

  5. Real-world data – large community oncology network.

Manufacturing
& Logistics

Convenient Patient-Centric Treatment
With Pipeline Redundancy

Multi-colored wheel displaying the 5 stages of Cellectar's manufacturing and distribution process. Patient centric is in dark blue with icon of patient laying in bed and a heart rate monitor displaying a heart beat. Logistics and stability is in light blue with icon of a dolly carrying a box. Manufacturing is in green with icon of a manufacturing plant. Radiopharmacy is in dark grey with icon of opened pill capsule. Radio Isotop Supply is in light grey with icon of hazard.

Compliance Statement


  • Iopofosine I-131 is an investigational agent and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.