Cellectar Shares Surge On FDA Breakthrough Therapy Designation For Cancer Drug Iopofosine I 131

(RTTNews) - Shares of Cellectar Biosciences, Inc. (CLRB) were gaining around 71 percent in the pre-market activity on the Nasdaq after the company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for iopofosine I 131 for the treatment of relapsed/refractory Waldenstrom macroglobulinemia or r/r WM.

The designation has been supported by CLOVER WaM Phase 2 Study data, which reported an 83.6% overall response rate.

Separately, the company announced that it has provided the European Medicines Agency or EMA with a data package that includes extensive supportive preclinical, regulatory and manufacturing data, as well as safety and efficacy data from the CLOVER WaM Phase 2b clinical trial.

The EMA will review the package to decide whether there is enough clinical evidence to address the required criteria for Cellectar to apply for a fast-track, conditional marketing authorization approval. The company expects a recommendation from the EMA in late July on whether Cellectar should file a Medical Authorization Application or MAA.

The late-stage clinical biopharmaceutical company focused on cancer drugs noted that iopofosine I 131 is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy.

According to the International Waldenstroms Macroglobulinemia Foundation, WM, the dominant subtype of lymphoplasmacytic lymphoma, remains incurable with available therapies, and approved WM treatment options are limited.

James Caruso, president and chief executive officer of Cellectar, said, "The FDAs Breakthrough Therapy Designation underscores the potential of iopofosine I 131 as it may offer substantial improvement on at least one clinically significant endpoint over available therapies to address the substantial unmet medical need in this life-threatening cancer. With robust clinical data, a favorable safety profile, expedited review designations in the United States and Europe and a compelling commercial market potential, we believe iopofosine I 131 represents an attractive candidate for potential collaborations or partners seeking impactful innovation and accelerated development pathways."

The company noted that data from the Phase 2 CLOVER WaM study (NCT02952508), including the overall response rate of 83.6% and a major response rate of 58.2%, which exceeded the agreed-upon primary endpoint of a 20% MRR, during the 66th Annual American Society of Hematology Conference in December 2024.

As previously announced, the FDA also granted iopofosine I 131 Fast Track Designation and Orphan Drug Designation. The EMA granted Orphan Drug Designation to iopofosine I131 for treatment of r/r WM, as well as PRIME Designation for WM.

On the Nasdaq, Cellectar Biosciences shares were gaining around 71 percent in the pre-market activity, after closing Tuesday's regular trading 6% higher.

For More Such Health News, visit rttnews.com