Cellectar Biosciences reports strategic reprioritization, reduces headcount 60%

Cellectar Biosciences (CLRB) announces a strategic update on its clinical development programs for its proprietary phospholipid ether drug conjugate platform that delivers a broad array of therapeutic modalities to target cancers. Due to recent communications with the U.S. 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. 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 as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 as a treatment for Waldenstrom’s macroglobulinemia. Based upon a recent Type-C meeting with the FDA, the company now believes 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. “While iopofosine I 131’s positive WM data along with the high unmet medical need for these patients support further investment, we have determined that such a program may best be brought to market by a larger organization with greater resources. Importantly, partnering or divesting this program supports our commitment to providing this potentially life-saving drug to the patients who need it as quickly as possible,” stated James Caruso, president and CEO of Cellectar. “We believe iopofosine I 131 represents a compelling opportunity as it has shown strong efficacy and good tolerability based on our clinical studies. Moreover, the commercial work we conducted demonstrates iopofosine I 131’s substantial market opportunity based upon the product profile, which includes off-the-shelf global distribution, orphan pricing and existing unmet medical need.” Cellectar remains confident in the potential of its phospholipid ether drug conjugate platform and the targeted radiotherapies in its development pipeline. Iopofosine I 131’s clinical success validates the platform’s ability to target cancers and Cellectar will leverage its experience to focus on the development of its earlier clinical programs. Specifically, 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 now 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. Both programs have demonstrated robust in vivo activity, tolerability, excellent targeting and uptake in preclinical solid tumor models. The company believes this approach will provide an expedited timeframe to achieve safety and proof-of-concept data in patients. The company’s strategic reprioritization will impact all departments and result in an immediate reduction in headcount of 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. “We are being methodical in our efforts to reorganize the company with the goal of conserving cash while maintaining the flexibility to execute immediate priorities and build for long-term growth and value creation. This reorganization is difficult but necessary for the future growth potential of Cellectar,” said Caruso. “I want to extend my deepest gratitude to our departing employees for their significant contributions to our work and their dedication to making a difference in the lives of patients.”