Patent covers composition of mat­ter and use in solid and liquid tumor cancer indi­ca­tions

Florham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of targeted treat­ments for cancer, an­nounces that the Japan Patent Office has granted the pat­ent titled “Phos­pho­lipid Analogs as Diapeutic Agents and Methods of Use Thereof” with appli­ca­tion num­ber 2016135920. The pat­ent provides composition of mat­ter and use pro­tec­tion for the com­pany’s pro­pri­e­tary phos­pho­lipid ether (PLE) analogs and spe­cif­i­cally CLR 131 in breast, brain, leukemias and a variety of other cancers.

“Certain cancers such as pedi­atric lym­phomas and leukemias have a higher prev­a­lence in Asia and rep­re­sent unmet need both within and outside the region,” said Jim Caruso, pres­i­dent and chief exec­u­tive officer of Cellectar Biosciences. “The issuance of this pat­ent en­hances our grow­ing in­tel­lec­tual property port­folio in this stra­te­gically im­por­tant mar­ket and provides incremental value to CLR 131 and our PLE de­livery fran­chise.”

About Phospholipid Drug Conjugates™

Cellectar's prod­uct can­di­dates are built upon a pat­ented de­livery and retention 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’ thera­peutic window to be modified, which may main­tain or en­hance drug potency while reducing the num­ber and severity of adverse events. This plat­form takes ad­van­tage of a metabolic path­way uti­lized by all tumor cell types in all cell cycle stages. Compared with other targeted de­livery plat­forms, the PDC plat­form’s mech­a­nism of entry does not rely upon spe­cif­ic cell surface epitopes or an­ti­gens. In addi­tion, PDCs can be con­ju­gated to mol­e­cules in nu­mer­ous ways, thereby in­creas­ing the types of mol­e­cules 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 Cellectar’s inves­ti­ga­tional radioiodinated PDC ther­apy that exploits the tumor-targeting properties of the com­pany's pro­pri­e­tary PLE and PLE analogs to selec­tively de­liver radi­a­tion to malignant tumor cells, thus minimizing radi­a­tion exposure to nor­mal tissues. CLR 131 is in a Phase 2 clin­i­cal study in re­lapsed / re­frac­tory mul­ti­ple myeloma (R/R MM) and a range of B-cell malig­nan­cies, and a Phase 1b clin­i­cal study in patients with R/R MM exploring frac­tion­ated dosing. The objective of the multi­center, open-label, Phase 1b dose-escalation study is the char­ac­ter­i­za­tion of safety and tol­er­a­bil­ity of CLR 131 in patients with R/R MM. Patients in Cohorts 1-4 re­ceived single doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2 as well as a frac­tion­ated dose of 15.625 mCi/m2 given twice over seven days in Cohort 5. All study doses and regi­mens have been deemed safe and well tol­er­ated by an in­de­pen­dent Data Monitoring Com­mit­tee. The com­pany plans to ini­ti­ate a Phase 1 study with CLR 131 in pedi­atric solid tumors and lym­phoma as well as a sec­ond Phase 1 study in com­bi­na­tion with ex­ternal beam radi­a­tion for head and neck cancer.

About Cellectar Biosciences, Inc.

Cellectar Biosciences is focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer. The com­pany plans to de­vel­op pro­pri­e­tary drugs in­de­pen­dent­ly and through re­search and devel­op­ment (R&D) col­lab­o­rations. The core drug devel­op­ment strat­e­gy is to leverage our PDC plat­form to de­vel­op thera­peutics that spe­cif­i­cally target treat­ment to cancer cells. Through R&D col­lab­o­rations, the com­pany’s strat­e­gy is to gen­er­ate near-term capital, supple­ment in­ternal resources, gain access to novel mol­e­cules or pay­loads, ac­cel­er­ate prod­uct can­di­date devel­op­ment and broaden our pro­pri­e­tary and part­nered prod­uct pipe­lines.

The com­pany's lead PDC thera­peutic, CLR 131, is in a Phase 1 clin­i­cal study in patients with R/R MM and a Phase 2 clin­i­cal study in R/R MM and a range of B-cell malig­nan­cies. The com­pany plans to ini­ti­ate a Phase 1 study with CLR 131 in pedi­atric solid tumors and lym­phoma as well as a sec­ond Phase 1 study in com­bi­na­tion with ex­ternal beam radi­a­tion for head and neck cancer. The com­pany’s prod­uct pipe­line also in­cludes one pre­clin­i­cal PDC chemo­ther­a­peu­tic pro­gram (CLR 1900) and part­nered assets in­­clud­ing PDCs from mul­ti­ple R&D col­lab­o­rations.

For more in­for­ma­tion please visit www.cellectar.com.

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. 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, the com­ple­tion of clin­i­cal trials, the FDA review process and other gov­ern­ment reg­u­la­tion, 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, 2017 and our Form 10-Q for the quar­ter­ly period ended Sep­tem­ber 30, 2018. 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 Biosciences.