Cellectar Biosciences, Inc., a clinical-stage biopharmaceutical company specializing in developing and marketing innovative cancer therapeutics, has unveiled an update on its clinical development efforts surrounding its exclusive phospholipid ether drug conjugate platform. This technology facilitates the delivery of diverse therapeutic agents towards cancerous targets.
Recently, following discussions with the U.S. Food and Drug Administration (FDA) about a confirmatory study and regulatory submission for iopofosine I 131 aiming for accelerated approval, the company is exploring strategic pathways for advancing and commercializing this potential treatment. The CLOVER-WaM study was carried out per previous FDA dialogue following a phase 2 conclusion meeting and a session in early 2024, indicating that favorable major response rate (MRR) results could support the fast-track approval for iopofosine I 131 as a treatment option for Waldenstrom’s macroglobulinemia (WM).
It is assessing strategic avenues for iopofosine I 131, a program in advanced clinical stages with strong phase 2 findings and significant market prospects.
Their focus has shifted towards advancing radiotherapeutic ventures, including alpha- and Auger-emitting radioconjugates, into phase 1 studies aimed at solid tumors.
After a recent Type-C meeting with the FDA, Cellectar recognizes that any accelerated approval bid would require MRR data from CLOVER-WaM and participant recruitment in a randomized, controlled study designed to establish progression-free survival (PFS) metrics.
“As much as iopofosine I 131’s promising WM data and the immense unmet medical need warrant additional investment, we believe the program could reach the market more effectively through collaboration with a larger organization capable of tapping into greater resources. Importantly, collaborating or divesting this initiative aligns with our drive to hasten access for patients who need this potentially life-saving treatment,” stated James Caruso, Cellectar’s president and CEO. “We see iopofosine I 131 as a promising prospect, having exhibited strong efficacy and tolerability according to clinical findings. Additionally, our commercial insights envisage a substantial market opportunity driven by the product’s profile, including globally accessible distribution, orphan drug pricing, and existing unmet needs.”
Cellectar remains confident in the capabilities of its phospholipid ether drug conjugate platform and its trajectory of targeted radiotherapies under development. The clinical success of iopofosine I 131 reaffirms the platform’s efficacy in cancer targeting, prompting Cellectar to channel its know-how into amplifying its earlier-stage projects.
The company plans to concentrate on assets identified as holding the most significant therapeutic potential and ability to generate value. Considering recent developments and alliances in the radiopharmaceutical space, precision radioisotopes such as alpha- and Auger-emitters are increasingly recognized as pivotal. Cellectar intends to allocate resources towards combating solid tumors by driving its actinium-225 program, CLR 121225, and its iodine-125 Auger-emitter, CLR 121125, into clinical phases.
The corporation plans to submit Investigational NDAs for CLR-121225 and CLR-121125 in the first half of 2025, allowing phase 1 clinical trials for solid tumor treatment to commence. Both programs have displayed consistent in vivo effectiveness, tolerability, and exceptional targeting and uptake within preclinical solid tumor models. Cellectar anticipates this strategic approach will promptly yield safety and proof-of-concept data for patients.
As part of its strategic realignment, the company expects a complete 60% workforce reduction by the fourth quarter of 2024, extending its cash runway to the third quarter of 2025.
“We are approaching the company’s reorganization carefully to conserve funds while retaining the flexibility to address present priorities, ensuring long-term success and value creation. Though difficult, this restructuring is paramount for Cellectar’s future growth,” commented Caruso. “I would like to express my sincere appreciation to our departing staff for their outstanding contributions and dedication to impacting patient care.”