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 Com­mis­sion has awarded CLR 131 orphan desig­na­tion for the treat­ment of mul­ti­ple myeloma.

Orphan desig­na­tion is given to medicinal prod­ucts that rep­re­sent a sig­nif­i­cant benefit over existing treat­ments; are in­tended for the treat­ment, prevention or diag­nosis of a dis­ease that is life-threatening or chronically debilitating; and where prev­a­lence of the con­di­tion in the EU is less than 5 in 10,000 persons.

“We are very pleased to re­ceive Orphan Drug Desig­na­tion from the Euro­pean Com­mis­sion as it is another im­por­tant acknowledgement of the poten­tial benefits of CLR 131 in mul­ti­ple myeloma,” said James Caruso, pres­i­dent and CEO of Cellectar Biosciences. “This desig­na­tion com­ple­ments our U.S. orphan drug desig­na­tion and U.S. fast track desig­na­tion already granted by the FDA. CLR 131 has shown en­cour­ag­ing results to date in the treat­ment of late line re­lapsed / re­frac­tory mul­ti­ple myeloma as dem­onstrated in our recent pre­sen­ta­tion at the Inter­na­tional Myeloma Workshop. We look for­ward to sharing addi­tional data from our clin­i­cal trials later this year.”

The Euro­pean Medicines Agency (EMA) plays a central role in facilitating the devel­op­ment and authori­za­tion of med­i­cines for rare dis­eases. Orphan desig­na­tion benefits in­clude protocol assistance, reduced EU regu­la­tory filing fees and 10 years of mar­ket exclusivity. Designated orphan med­i­cines are also eli­gible for con­di­tional mar­ket­ing authori­za­tion. Detailed in­for­ma­tion on orphan desig­na­tion can be found here.

About CLR 131

CLR 131 is a small-molecule, cancer-targeting radiotherapeutic Phospholipid Drug ConjugateTM (PDC) de­signed to de­liver cytotoxic radi­a­tion directly and sel­ectively to cancer cells and cancer stem cells. CLR 131 is the com­pany’s lead thera­peutic PDC prod­uct can­di­date and is cur­rently being eval­u­ated in both Phase 2 and Phase 1 clin­i­cal stud­ies. The FDA granted orphan drug desig­na­tion for CLR 131 for the treat­ment of mul­ti­ple myeloma as well as orphan drug and rare pedi­atric dis­ease desig­na­tions for CLR 131 for the treat­ment of neu­ro­blas­toma, rhab­do­myo­sar­coma, Ewing’s sarcoma and osteo­sar­coma. In addi­tion to the on­go­ing Phase 1 dose-escalation study and the Phase 2 (CLOVER-1) trial, the com­pany recently ini­ti­ated a Phase 1 open-label, dose-escalating study in pedi­atric solid tumors and lym­phoma to eval­u­ate the safety and tol­er­a­bil­ity of a single in­tra­venous admin­istra­tion of CLR 131 in up to 30 chil­dren and adolescents with cancers in­clud­ing neu­ro­blas­toma, sarcomas, lym­phomas (including Hodgkin’s lym­phoma) and malignant brain tumors.

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 (R&D) col­lab­o­rations. The com­pany’s core objective is to leverage its pro­pri­e­tary Phospholipid Drug ConjugateTM (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 cur­rently in three clin­i­cal stud­ies – a Phase 2 study, and two Phase 1 stud­ies. The Phase 2 clin­i­cal study (CLOVER-1) is in re­lapsed / re­frac­tory (R/R) B-cell malig­nan­cies, in­clud­ing mul­ti­ple myeloma (MM), chronic lym­pho­cytic leukemia/small lym­pho­cytic lym­phoma (CLL/SLL), lym­pho­plas­ma­­cytic lym­phoma (LPL), marginal zone lym­phoma (MZL), mantle cell lym­phoma (MCL), and diffuse large B-cell lym­phoma (DLBCL). The com­pany is also con­ducting a Phase 1 dose escalation study in patients with R/R mul­ti­ple myeloma (MM) and a Phase 1 study in pedi­atric solid tumors and lym­phoma.

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

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, 2018 and Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019. 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.