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CLRB-News
CLRB-Events
Cellectar Advances Regulatory Strategy for iopofosine I 131
"Our second quarter marked another period of significant execution as we continued to advance multiple programs across our oncology pipeline while laying the foundation for several important near-term catalysts," said James Caruso, president and chief executive officer of Cellectar. "Most notably, we progressed our regulatory strategy for iopofosine I 131 in Waldenstrom macroglobulinemia, including initiation of site activation activities for our confirmatory Phase 3 trial, which is an important first step toward our accelerated approval application in the U.S., which we plan to submit in mid-2027. The compelling data we continue to generate from the Phase 2b CLOVER WaM study reinforce our belief that iopofosine has the potential to address a critical unmet need for WM patients, including those previously treated with BTK inhibitors and prior to off-label salvage therapies."
Cellectar Publishes Results of iopofosine I 131 Study
Cellectar Biosciences announced the publication of results from a Phase 1 dose-escalation study evaluating iopofosine I 131 in combination with low-dose dexamethasone in 31 patients with heavily pretreated relapsed/refractory multiple myeloma. The manuscript was published in the peer-reviewed journal, Cancers. The study evaluated both single-dose and fractionated-dose regimens of iopofosine I 131 in 31 heavily pretreated r/r MM patients, many of whom had exhausted available treatment options. Among 26 efficacy-evaluable patients: clinical activity appeared more pronounced in patients receiving higher total administered doses; 84.6% achieved stable disease or better following treatment; 30% overall response rate observed among evaluable patients receiving at least 60 mCi of iopofosine I 131; the overall response rate was 15.4%, with four patients achieving partial responses; investigators reported a favorable and manageable safety profile, with adverse events primarily consisting of predictable and reversible hematologic toxicities and no new safety signals were identified, and non-hematologic adverse events were generally low grade.
Cellectar Biosciences Files to Sell 51.21M Shares of Common Stock
Cellectar Biosciences files to sell 51.21M shares of common stock for holders
Cellectar Completes Up to $140 Million Financing
"The first part of 2026 was a pivotal period for Cellectar as we executed across our pipeline and capital strategies to position the company for value creation," said James Caruso, president and chief executive officer of Cellectar. "With the support of industry-leading healthcare focused investors, we successfully completed a financing of up to $140 million, providing the necessary resources to advance iopofosine through key U.S. regulatory milestones and potential commercialization. The recently reported positive 12-month follow-on data from our CLOVER WaM study reinforce our confidence that iopofosine can provide meaningful patient benefits and meet regulatory expectations, supporting our plans to initiate a Phase 3 confirmatory study and file for accelerated approval with the FDA," Caruso continued.
Cellectar Updates iopofosine I 131 Clinical Trial Data
Cellectar Biosciences announced updated and mature 12-month follow-up data from its Phase 2b CLOVER WaM clinical trial evaluating iopofosine I 131 in patients with relapsed or refractory Waldenstrom macroglobulinemia. The updated dataset includes a minimum of 12 months of follow-up for all enrolled patients, as requested by the FDA, and the durability data presented here, further strengthen the previously reported efficacy results. The company also reports subset analyses from CLOVER WaM showing iopofosine I 131 demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients. Patients enrolled in the CLOVER WaM clinical trial had a median of four prior lines of therapy, with refractory rates running from 77% in Bruton tyrosine kinase inhibitors-exposed patients to 60% in chemotherapy-exposed patients and 58% in patients exposed to both BTKi and rituximab, making this one of the most heavily pretreated and refractory WM populations studied to date. Updated 12-month data demonstrated high response rates and sustained durability, supporting its accelerated regulatory pathway and potential role as a differentiated treatment option. During the follow-up period, responses deepened and remained durable, especially considering that treatment with iopofosine I 131 is a fixed-dosed regimen containing four 30-minute infusions. Adverse events were transient and unlike other therapies approved for WM there were no significant bleeding events and low rates of infection. Cytopenias were the most common treatment-emergent adverse events. Non-hematologic toxicities were primarily low grade Iopofosine I 131 demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients, populations that are among the most difficult to treat. These results demonstrate durability and depth of response comparable to, or exceeding, the overall study population, reinforcing the consistency of iopofosine's activity across treatment-resistant subgroups. Furthermore, comparative assessments with published datasets suggest that iopofosine I 131 delivers superior efficacy across key endpoints relative to currently available salvage therapies in similar patient populations.
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