Designation could ac­cel­er­ate CLR 131 devel­op­ment and underscores the need for new treat­ments

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 U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track Desig­na­tion for CLR 131 in fourth line or later re­lapsed / re­frac­tory mul­ti­ple myeloma. CLR 131 is the com­pany’s small-molecule radiotherapeutic phos­pho­lipid drug con­ju­gate (PDC™) de­signed to de­liver cytotoxic radi­a­tion directly and sel­ectively to cancer cells and cancer stem cells. It is cur­rently being eval­u­ated in Cellectar’s on­go­ing CLOVER-1 Phase 2 clin­i­cal study in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma and other select B-Cell lym­phomas.

“Fast Track Desig­na­tion fur­thers our efforts to expeditiously de­vel­op CLR 131 as a new, inno­va­tive ther­apy for patients with relapse/refractory mul­ti­ple myeloma,” said James Caruso, pres­i­dent and CEO of Cellectar. “Patients with third line or later re­lapsed / re­frac­tory mul­ti­ple myeloma have a poor prog­nosis and low rates of sur­vival as a result of limited ef­fec­tive treat­ment op­tions. Based on data in the initial patient cohort from our on­go­ing CLOVER-1 trial where patients showed a 30% re­sponse rate after re­ceiv­ing a single 25.0 mCi/m² dose as a seventh line of ther­apy on average, we are op­ti­mis­tic that CLR 131 has the poten­tial to provide a meaningful treat­ment op­tion for these patients.”

Fast Track Desig­na­tion

Fast Track Desig­na­tion is granted to drugs being devel­oped for the treat­ment of serious or life-threatening dis­eases or con­di­tions where there is an unmet med­i­cal need. The pur­pose of the Fast Track Desig­na­tion provision is to help facilitate devel­op­ment and expedite the review of drugs to treat serious and life-threatening con­di­tions.

Sponsors of drugs that re­ceive Fast Track Desig­na­tion have the oppor­tu­ni­ty for more fre­quent inter­actions with the FDA review team through­out the devel­op­ment pro­gram. These inter­actions may in­clude meetings to discuss study design, data re­quired to sup­port ap­prov­al, or other as­pects of the clin­i­cal pro­gram. Addi­tionally, prod­ucts that have been granted Fast Track Desig­na­tion may be eli­gible for priority review of a New Drug Appli­ca­tion (NDA) and the FDA may con­sider reviewing portions of an NDA before the sponsor submits the com­plete appli­ca­tion (Rolling Review).

About the Phase 2 CLOVER-1 Trial

CLOVER-1 is a Phase 2 study of CLR 131 being con­ducted in approx­i­mately 10 lead­ing cancer centers in the United States in patients with re­lapsed or re­frac­tory B-cell hema­to­logic cancers. The hema­to­logic cancers being studied in the trial in­clude 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 study's pri­mary end­point is clin­i­cal benefit re­sponse (CBR), with addi­tional end­points of over­all re­sponse rate (ORR), pro­gres­sion free sur­vival (PFS), median over­all sur­vival (OS) and other markers of ef­fi­cacy fol­low­ing a frac­tion­ated dose of 15.625 mCi/m2 dose of CLR 131 admin­istered on day 1 and day 8, with the op­tion for a sec­ond dose cycle approx­i­mately 75-180 days later.

In addi­tion to re­ceiv­ing the two frac­tion­ated doses of CLR 131, MM patients will re­ceive 40 mg oral dexa­meth­a­sone weekly for up to 12 weeks. Efficacy re­sponses will be de­ter­mined by the latest Inter­na­tional Multiple Myeloma Work­ing Group criteria. Efficacy for all lym­phoma patients will be de­ter­mined ac­cord­ing to Lugano criteria. Cellectar was awarded approx­i­mately $2 million in non-dilutive grant funding from the National Cancer In­sti­tute to help fund the trial. More in­for­ma­tion about the trial, in­­clud­ing eligibility re­quire­ments, can be found at www.clinicaltrials.gov, reference NCT02952508.

About CLR 131

CLR 131 is a small-molecule, cancer-targeting radiotherapeutic 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. In De­cem­ber 2014, the FDA granted orphan drug desig­na­tion for CLR 131 for the treat­ment of mul­ti­ple myeloma. In 2018, the FDA granted 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 plans to de­vel­op pro­pri­e­tary drugs in­de­pen­dent­ly and through re­search and devel­op­ment (R&D) col­lab­o­rations. The core drug devel­op­ment strat­e­gy is to leverage its PDC plat­form to de­vel­op thera­peutics that spe­cif­i­cally target treat­ment to cancer cells. Through R&D col­lab­o­rations, Cellectar seeks 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 2 clin­i­cal study (CLOVER-1) in R/R MM and select B-cell malig­nan­cies, as well as a dose escalation Phase 1 study in patients with R/R MM. The com­pany has ini­ti­ated a Phase 1 study with CLR 131 in pedi­atric solid tumors and lym­phoma.

Cellectar’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 quarter ended March 31, 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.