FLORHAM PARK, N.J. - Cellectar Biosciences, Inc. (NASDAQ: NASDAQ:CLRB), a late-stage clinical biopharmaceutical company, today revealed significant outcomes from its CLOVER WaM pivotal study.
The study evaluated iopofosine I 131, a targeted radiotherapeutic candidate for relapsed/refractory Waldenstrom’s macroglobulinemia (WM). The study reported an overall response rate (ORR) of 80% and a major response rate (MRR) of 56.4%, surpassing the study’s primary endpoint of a 20% MRR.
The CLOVER WaM study has been noted as the first and largest of its kind, focusing on a patient population that has shown resistance to all available treatment options. As of May 31, 2024, the study, which included patients who had undergone at least two prior lines of therapy, reported no median duration of response (DoR) reached, with a majority of patients remaining progression-free at 18 months.
Lead investigator Sikander Ailawadhi, M.D., from the Mayo Clinic, highlighted the limited treatment options for WM patients, especially those who do not respond to salvage therapy. The study demonstrated a 98% disease control rate and impressive ORR, suggesting that iopofosine I 131 could become a standard-of-care therapy for this patient group.
The company plans to submit a New Drug Application (NDA) for iopofosine I 131 in the fourth quarter of 2024 and will seek priority review. James Caruso, president and CEO of Cellectar, expressed the company's commitment to making iopofosine available to patients in need of new treatment options.
Iopofosine I 131's safety profile was consistent with prior data, showing no cardiovascular, renal, or liver toxicities, and no significant peripheral neuropathy or bleeding. The most common treatment-related adverse events were hematologic but were manageable and reversible.
WM is an incurable B-cell malignancy with a US prevalence of approximately 26,000 cases, with 1,500-1,900 new diagnoses each year. The unmet need for novel, FDA-approved treatments with durable responses and time-limited treatment is significant, particularly for heavily pretreated patients.
This news is based on a press release statement from Cellectar Biosciences.
InvestingPro Insights
Cellectar Biosciences, Inc. (NASDAQ: CLRB) has shared promising results from its pivotal CLOVER WaM study, which could potentially shift the treatment paradigm for Waldenstrom’s macroglobulinemia. As the company prepares for a New Drug Application, investors are closely monitoring Cellectar's financial health and market performance. Here are some key insights from InvestingPro:
InvestingPro Data for Cellectar Biosciences highlights a market capitalization of $108.26 million. Despite a negative P/E Ratio of -1, reflecting challenges in profitability, the company has seen an impressive one-week price total return of 8.24% as of the latest data. This recent uptick in share price performance aligns with the positive clinical trial outcomes reported, suggesting investor confidence may be growing in anticipation of potential FDA approval and market entry.
Two notable InvestingPro Tips for Cellectar include analysts revising their earnings upwards for the upcoming period, which could signal expectation of improved financial performance. Additionally, although the company is not expected to be profitable this year and is quickly burning through cash, it holds more cash than debt on its balance sheet, which could provide some financial cushioning as it advances its clinical programs.
Investors interested in a deeper dive into Cellectar's financials and market prospects can find a wealth of additional InvestingPro Tips at https://www.investing.com/pro/CLRB. For those looking to subscribe to InvestingPro for further insights, use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. With 12 additional tips listed on InvestingPro, subscribers can gain a comprehensive understanding of Cellectar's investment potential.
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