On Tuesday, Cellectar Biosciences, Inc. (NASDAQ:CLRB) unveiled a strategic update on its clinical development programs for its proprietary phospholipid ether drug conjugate platform, which targets cancer.
Due to recent communications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the company has decided to pursue strategic options for the further development and commercialization of this product candidate.
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The CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end-of-Phase 2 meeting and from a meeting in early 2024, during which the company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 for Waldenstrom's macroglobulinemia (WM).
Based on a recent Type-C meeting with the FDA, the company says that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS).
Cellectar will focus on those assets it believes have the highest therapeutic potential and opportunity for value creation.
As highlighted by recent acquisitions and collaborations within the radiopharmaceutical sector, precision isotopes like alpha- and Auger-emitters have emerged as the leading therapeutics of interest.
Consequently, the company will focus its resources on targeting solid tumors by advancing CLR 121225, its actinium-225-based program, and CLR 121125, its iodine-125 Auger-emitting program, into the clinic.
Cellectar expects to file Investigational New Drug applications in the first half of 2025 for both CLR-121225 and CLR-121125, which will allow the initiation of Phase 1 clinical studies in solid tumor cancers.
The company will reduce its headcount by approximately 60%, which should be complete by the end of the fourth quarter 2024. The company anticipates that the implementation of the restructuring will extend its cash runway into the third quarter of 2025.
Price Action: CLRB stock is down 73.40% at $0.34 at the last check on Wednesday.
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