Clinical Trials to Advance Across Multiple He­ma­tol­ogy Programs

{{image}}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, an­nounces to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has granted an exemption to the Import Alert placed on the Centre for Probe De­vel­op­ment and Com­mer­cial­i­za­tion (CPDC), the sole supplier of the CLR 131. The exemption for CLR 131 is ef­fec­tive im­medi­ately for all he­ma­tol­ogy stud­ies and, in re­sponse, Cellectar is preparing to dose patients in the sec­ond frac­tion­ated dose cohort of the Phase 1 re­lapsed re­frac­tory (R/R) mul­ti­ple myeloma study and the Phase 2 study for R/R hema­to­logic malig­nan­cies. The com­pany awaits authori­za­tion from the FDA for any future shipments in con­nec­tion with its Phase 1 study of pedi­atric patients with neu­ro­blas­toma, sarcomas, lym­phomas (including Hodgkin’s lym­phoma) and malignant brain tumors.

“We thank the FDA for their diligence and for providing this exemption for CLR 131 he­ma­tol­ogy stud­ies. Our ability to ad­vance our clin­i­cal trials and achieve stated business objectives remains our top priority,” said James Caruso, pres­i­dent and CEO of Cellectar Biosciences. “I also want to recog­nize our team for their out­stand­ing execution in sup­port of a rapid resolution.”

In its efforts to obtain an exemption for CLR 131 from the Import Alert in he­ma­tol­ogy and pedi­atrics, Cellectar has col­lab­o­rated with the var­i­ous divisions within the FDA that oversee the com­pany’s inves­ti­ga­tional new drug appli­ca­tions eval­u­ating CLR 131 in mul­ti­ple indi­ca­tions. Cellectar executed a series of actions re­quested by the FDA to obtain an exemption to the Import Alert for its he­ma­tol­ogy pro­grams. Similarly, the com­pany con­tinues to work with the appro­pri­ate division of the FDA to secure an exemption for the pedi­atric pro­gram.

As back­ground, on August 10, 2018, Cellectar an­nounced that CPDC was in­formed of an FDA Import Alert that prohibited CPDC from supplying CLR 131. While the Import Alert disrupted CLR 131 supply, the basis of the Import Alert was not re­lated to CLR 131 spe­cif­i­cally, or to CPDC’s pro­duc­tion facility asso­ci­ated with CLR 131. The com­pany actively sup­ported CPDC’s efforts to have the Import Alert lifted as quickly as possible. The FDA sub­se­quently ini­ti­ated direct talks with Cellectar con­cern­ing a possible exemption for CLR 131 from the Import Alert. Those dis­cus­sions and sub­se­quent actions resulted in the exemption Cellectar is announcing to­day.

About CLR 131

CLR 131 is Cellectar’s inves­ti­ga­tional radioiodinated PDC ther­apy that exploits the tumor-targeting properties of the com­pany's pro­pri­e­tary phos­pho­lipid ether (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 two pre­clin­i­cal PDC chemo­ther­a­peu­tic pro­grams (CLR 1700 and 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 June 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.