Patent covers the phos­pho­lipid ether (PLE) de­livery vehicle com­bined with I-131 and I-125

Florham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, de­vel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day an­nounced that the Euro­pean Patent Office has granted pat­ent num­ber EP 2440253 titled “Ether and Alkyl Phospholipid Compounds for Treating Cancer and Imaging and Detection of Cancer Stem Cells." The pat­ent provides composition of mat­ter and use pro­tec­tion for the treat­ment and/or diag­nosis of cancer and cancer stem cells for the com­pany’s Phase 2 lead asset CLR 131 and the pro­pri­e­tary PLE analogs com­bined with I-125 (CLR 125).

“Few drugs have shown the capacity to target and ef­fec­tively treat highly resistant cancer stem cells. We be­lieve CLR 131’s dem­onstrated ability to kill both con­ven­tional cancer cells as well as dif­fi­cult-to-treat cancer stem cells is a unique treat­ment benefit of this drug,” stated Jim Caruso CEO & pres­i­dent of Cellectar Biosciences. “Importantly, this pat­ent provides addi­tional long-term pro­tec­tion for our lead com­pound CLR 131 in the sec­ond largest global mar­ket and rep­re­sents an im­por­tant ex­pan­sion of our in­tel­lec­tual property pro­tec­tions for our port­folio of targeted on­col­ogy prod­uct can­di­dates.”

About Phospholipid Drug Conjugates™

Cellectar's prod­uct can­di­dates are built upon a pat­ented de­livery plat­form that uti­lizes op­ti­mized phos­pho­lipid ether-drug con­ju­gates (PDCs™) to target cancer cells. The PDC plat­form sel­ectively de­livers diverse onco­logic pay­loads to can­cer­ous cells and cancer stem cells, in­clud­ing hema­to­logic cancers and solid tumors. This sel­ective de­livery allows the pay­loads’ con­cen­tra­tion within tumor cells to be in­creased while reducing the con­cen­tra­tion in nor­mal tissue, which may en­hance drug potency while reducing adverse events. This plat­form takes ad­van­tage of a metabolic path­way uti­lized by all tumor cell types. Compared with other targeted de­livery plat­forms, the PDC plat­form’s mech­a­nism of entry does not rely upon spe­cif­ic cell surface epitopes or an­ti­gens which can be modified or removed by tumor cells re­sult­ing in re­sis­tance to the treat­ment. In addi­tion, PDCs can be con­ju­gated to mol­e­cules in nu­mer­ous ways, thereby in­creas­ing the types or classes of mol­e­cules that can be sel­ectively de­liv­ered. Cellectar be­lieves the PDC plat­form holds poten­tial for the discovery and de­vel­op­ment of the next gen­er­a­tion of cancer-targeting agents.

About CLR 131

CLR 131 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 unlike many traditional on-market treat­ment op­tions. CLR 131 is the com­pany’s lead prod­uct can­di­date and is cur­rent being eval­u­ated in a Phase 2 study in B-cell lym­phomas, and a Phase 1 dose-escalating clin­i­cal study in pedi­atric solid tumors and lym­phomas. The com­pany recently com­pleted a Phase 1 dose-escalation clin­i­cal study in r/r mul­ti­ple myeloma. The FDA granted CLR 131 Fast Track Desig­na­tion for both r/r mul­ti­ple myeloma and r/r diffuse large b-cell lym­phoma and Orphan Drug Desig­na­tion (ODD) for the treat­ment of mul­ti­ple myeloma, lym­pho­plas­ma­­cytic lym­phoma / Waldenstrom’s macro­glob­u­lin­emia, neu­ro­blas­toma, rhab­do­myo­sar­coma, Ewing’s sarcoma and osteo­sar­coma. CLR 131 was also granted Rare Pediatric Disease Desig­na­tions for the treat­ment of neu­ro­blas­toma, rhab­do­myo­sar­coma, Ewing’s sarcoma and osteo­sar­coma. Most recently, the Euro­pean Com­mis­sion granted an ODD for r/r mul­ti­ple myeloma.

About Cellectar Biosciences, Inc.

Cellectar Biosciences is focused on the discovery, de­vel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer. The com­pany is devel­op­ing pro­pri­e­tary drugs in­de­pen­dent­ly and through re­search and de­vel­op­ment col­lab­o­rations. The com­pany’s core objective is to leverage its pro­pri­e­tary Phospholipid Drug Conjugate™ (PDC) de­livery plat­form to de­vel­op PDCs that spe­cif­i­cally target cancer cells, de­livering im­proved ef­fi­cacy and better safety as a result of fewer off-target effects. The com­pany’s PDC plat­form possesses the poten­tial for the discovery and de­vel­op­ment of the next-gener­a­tion of cancer-targeting treat­ments, and it plans to de­vel­op PDCs in­de­pen­dent­ly and through re­search and de­vel­op­ment col­lab­o­rations.

The com­pany’s lead PDC thera­peutic, CLR 131, is cur­rent in two clin­i­cal stud­ies. The CLOVER-1 Phase 2 study com­pleted the Part A dose-exploration portion con­ducted in re­lapsed / re­frac­tory (r/r) B-cell malig­nan­cies and is now en­rolling in the Part B ex­pan­sion cohorts eval­u­ating an approx­i­mate 100mCi total body dose of CLR 131 in re­lapsed / re­frac­tory (r/r) mul­ti­ple myeloma (MM) and lym­pho­plas­ma­­cytic lym­phoma / Waldenstrom’s macro­glob­u­lin­emia (LPL / WM). The data from the Part A portion was an­nounced on Feb­ru­ary 20, 2020. The com­pany is also con­ducting a Phase 1 dose-escalation study in pedi­atric solid tumors and lym­phomas.

The com­pany’s prod­uct pipe­line in­cludes one pre­clin­i­cal PDC chemo­ther­a­peu­tic pro­gram (CLR 1900) and sev­er­al part­nered PDC assets.

For more in­for­ma­tion, please visit www.cellectar.com or join the conversation by liking and fol­low­ing us on the com­pany’s social media channels: Twitter, LinkedIn, and Face­book.

Forward-Looking State­ment Disclaimer

This news re­lease con­tains for­ward-looking state­ments. You can identify these state­ments by our use of words such as "may," "expect," "be­lieve," "antic­i­pate," "intend," "could," "esti­mate," "con­tinue," "plans," or their neg­a­tives or cognates. These state­ments are only esti­mates and predictions and are subject to known and unknown risks and un­cer­tainties that may cause actual future ex­peri­ence and results to differ ma­teri­ally from the state­ments made. These state­ments are based on our cur­rent beliefs and ex­pec­ta­tions as to such future out­comes in­clud­ing our ex­pec­ta­tions of the impact of the recent COVID-19 pan­dem­ic. Drug discovery and de­vel­op­ment in­volve­ a high degree of risk. Factors that might cause such a ma­teri­al dif­fer­ence in­clude, among others, un­cer­tainties re­lated to the ability to raise addi­tional capital, un­cer­tainties re­lated to the disruptions at our sole source supplier of CLR 131, the ability to attract and retain part­ners for our tech­nolo­gies, the identi­fi­ca­tion of lead com­pounds, the suc­cess­ful pre­clin­i­cal de­vel­op­ment thereof, patient en­roll­ment and the com­ple­tion of clin­i­cal stud­ies, the FDA review process and other gov­ern­ment reg­u­la­tion, our ability to main­tain orphan drug desig­na­tion in the United States for CLR 131, the volatile mar­ket for priority review vouchers, our pharma­ceu­tical col­lab­o­rators' ability to suc­cess­fully de­vel­op and com­mer­cialize drug can­di­dates, com­pe­ti­tion from other pharma­ceu­tical com­pa­nies, prod­uct pricing and third-party reim­burse­ment. A com­plete description of risks and un­cer­tainties re­lated to our business is con­tained in our periodic reports filed with the Se­cu­ri­ties and Ex­change Com­mis­sion in­clud­ing our Form 10-K for the year ended De­cem­ber 31, 2019 and our Form 10-Q for the quarter ended March 31, 2020. These for­ward-looking state­ments are made only as of the date hereof, and we disclaim any obli­ga­tion to up­date any such for­ward-looking state­ments. These for­ward looking state­ments are made only as of the date hereof, and we disclaim any obli­ga­tion to up­date any such for­ward-looking state­ments.

Source: Cellectar.