Cellectar Biosciences, Inc. (NASDAQ:CLRB) shares are up during Tuesday’s trading session as the company announced promising results from its Phase 2b CLOVER WaM clinical trial.
Trial Data Shows High Response Rates And Durability
The positive data highlight an overall response rate of 83.6% and a median duration of response of 17.8 months, suggesting strong efficacy for its treatment in heavily pretreated patients.
The trial evaluated iopofosine I 131 in patients with relapsed or refractory (r/r) Waldenström macroglobulinemia (WM), a rare, slow-growing blood cancer where abnormal B lymphocytes in the bone marrow produce excess immunoglobulin M protein.
CLOVER WaM Data Drives Stock Momentum
The clinical-stage biopharmaceutical company reported compelling follow-up data from its Phase 2b CLOVER WaM study, showing a 61.8% major response rate in patients with r/r Waldenström macroglobulinemia.
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.
Cellectar is advancing plans to initiate a confirmatory randomized study in a post-first-line, post-BTKi population. The study is expected to evaluate progression-free survival as the primary endpoint, consistent with regulatory guidance.
The company is also preparing for potential regulatory submissions in the United States and Europe, supported by the strength and maturity of the CLOVER WaM dataset.
Financing To Support Development And Filing
Concurrently on Tuesday, Cellectar Biosciences announced financing of up to $140 million, including approximately $35 million upfront and $105 million in milestone-based securities.
The financing will support the confirmatory study and the FDA filing for accelerated approval of Iopofosine I 131 in waldenström macroglobulinemia.
CLRB Price Action: Cellectar Biosciences shares were up 46.64% at $4.15 at the time of publication on Tuesday, according to Benzinga Pro data.
Image via Shutterstock
Login to comment