On September 13, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported the publication of a paper highlighting data from an expansion cohort of the ongoing Phase 2 CLOVER-1 study of iopofosine I-131 ("iopofosine") in relapsed/refractory B-cell malignancies in the September issue of Blood Cancer Journal, a peer-reviewed Nature journal (Press release, Cellectar Biosciences, SEP 13, 2022, View Source [SID1234619494]).

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The paper, entitled "Iopofosine I-131 treatment in late-line patients with relapsed/refractory multiple myeloma post anti-BCMA immunotherapy," showed initial results from the expansion cohort of seven post anti-BCMA immunotherapy quad-class refractory relapsed/refractory multiple myeloma patients with a median of 9 prior therapies. For inclusion in the analysis, patients had to receive a prior anti-BCMA CAR-T, antibody drug conjugate or bispecific antibody therapy. Six participants received the target of ≥60 mCi total administered dose of iopofosine, given as 4 doses over 71 days, while one patient received a total administered dose <60 mCi, and was not included in the analysis.

Initial findings in the population receiving ≥60 mCi total administered dose showed an overall response rate (ORR) of 50% and a minimum of stable disease for all treated patients. At the time of data cutoff, while median overall survival had not been reached, the mean overall survival was 9.1 months. The safety was manageable, with no dosing delays, dose reductions, or treatment discontinuations caused by adverse events. The most common grade 3/4 adverse events were cytopenias (thrombocytopenia (75%) and neutropenia (57%)), which is consistent with previous studies. None of the patients experienced febrile neutropenia, and all cytopenias resolved within the study period.

"The 50% overall response rate in patients from this expansion cohort who had received and failed an average of 9 lines of prior treatment, including many of the newer anti-BCMA therapies, CAR T-cell therapies, bispecific antibodies and antibody drug conjugates is impressive," said James Caruso, president and CEO of Cellectar. "We believe these findings along with data from previous clinical studies demonstrate the potential of iopofosine to broadly treat patients with aggressive hematologic cancers, like multiple myeloma, and less aggressive cancers, like Waldenstrom’s macroglobulinemia, which is currently under evaluation in our WAM Clover-1 pivotal study."

About iopofosine I-131

Iopofosine is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted ODDs for r/r MM and WM.