On September 22, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported it has been awarded $1.98 million in additional grant funding to expand its ongoing Phase 1 study of iopofosine I 131 (iopofosine) in children and adolescents with inoperable relapsed or refractory high grade gliomas (HGGs) (Press release, Cellectar Biosciences, SEP 22, 2022, View Source [SID1234621345]).
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The grant was awarded by the National Institute of Health’s National Cancer Institute (NCI) based upon the initial signals of efficacy in the Phase 1 study, which is an international, open-label, dose escalation, safety study. The funding allows for an expansion from the Part 1a into the Part 1b portion of the company’s ongoing Phase 1 pediatric study. To accelerate development, the study is designed as a two-part approach. The currently ongoing Phase 1a is designed to determine the safety, tolerability, and initial efficacy of iopofosine in pediatric brain tumors whereas the Phase 1b is designed to identify the dose and dosing regimen that results in optimal efficacy. Previously announced preliminary data demonstrated therapeutic responses to iopofosine as evidenced by changes in multiple tumor parameters and patients experiencing extended progression free survival.
"The approximately $2 million non-dilutive grant funding from the NCI’s peer reviewed process is additional validation that iopofosine has shown encouraging potential in this very difficult to treat patient population. Unfortunately, patients with HGGs often have very poor prognoses, with limited treatment options," said James Caruso, president and CEO of Cellectar. "We continue to be encouraged by the ability of iopofosine to cross the blood brain barrier, deliver sufficient radiation to the tumor and demonstrate early efficacy signals. We remain steadfastly committed to the thoughtful development of iopofosine in this devastating indication."
Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes including diffuse intrinsic pontine gliomas, glioblastomas, astrocytomas and ependymomas. Children with these tumors have very poor prognoses, with typical progression-free survival of only a few months and a 5-year survival of less than 30%.
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 an ODDs for r/r MM and WM.