Cellectar Biosciences, Inc. provided an update for its iopofosine I 131 clinical program and guidance related to its Waldenstrom's macroglobulinemia (WM) CLOVER-WaM pivotal trial, as well as preclinical advancements to its proprietary phospholipid ether drug conjugate platform. WM CLOVER-WaM pivotal study The company now expects to release top-line data from the WM CLOVER-WaM trial in the second half of 2023 and assuming FDA approval, remains on target for a 2024 product launch. Cellectar experienced delays with trial start-up activities, such as site contracting and country regulatory responses, which slowed the initial pace of site initiations resulting in lower-than-expected patient enrollment.

The company now has all 49 sites up and running and patient enrollment rates have accelerated. As has been previously reported, and in agreement with the FDA, WM CLOVER-WaM is a single arm, open label trial with a target enrollment of 50 patients. The company's COO, Jarrod Longcor, will deliver an oral presentation of iopofosine I131 in multiple myeloma at the Society of Nuclear Medicine and Molecular Imaging Annual Conference.

The presentation is on June 26(th) (#P1243, Using targeted radiotherapy in highly refractory multiple myeloma). Phospholipid ether cancer targeting platform Development of the company's phospholipid ether cancer targeting platforms continues to demonstrate its broad utility to provide targeted intracellular delivery of multiple cancer treatment modalities. Preclinical data recently presented at several conferences demonstrate the broad utility of the platform, including: multip e alpha-emitter radiotherapeutic programs targeting solid tumor; the activity of multiple cytotoxic smamall molecule payloads in triple negative breast cancer mouse models including eradication of the tumors with no subsequent regrowth; the successful delivery, uptake, and gene knockdown in a mouse model of pancreatic cancer with siRNA-phospholipid ether when given intravenously; and the conjugation and use of peptides against intracellular targets where small molecules may not be effective.