Covers composition of mat­ter and method of use into 2036 for pro­pri­e­tary PLE analogs in com­bi­na­tion with var­i­ous small mol­e­cule chemo­ther­a­peu­tics

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 an­nounced the intent to grant pat­ent num­ber EP3229810 (B1) titled “Phospholipid Ether Analogs as Cancer-Targeting Drug Vehicles.” The pat­ent provides composition of mat­ter and use pro­tec­tion for the com­pany’s pro­pri­e­tary PLE, targeted de­livery vehicle analogs in com­bi­na­tion with a broad range of chemo­ther­a­peu­tics such as paclitaxel, gemcitabine, and other classes of small mol­e­cule chemo­ther­a­peu­tic agents. The cancer-targeting PLE de­livery vehicle serves as the foundation for the com­pany’s lead prod­uct can­di­date CLR 131, which con­tinues to ad­vance through clin­i­cal stud­ies in both adult and pedi­atric cancer in­di­ca­tions.

“This pat­ent rep­re­sents a key step to­wards the ex­pan­sion of our PDC fran­chise into the Euro­pean and the rest of the world mar­kets. It provides in­tel­lec­tual property pro­tec­tion for many of our on­go­ing pre­clin­i­cal pro­grams, similar to the pre­vi­ously granted U.S. pat­ent,” stated James Caruso pres­i­dent and chief exec­u­tive officer of Cellectar Bio­sciences. “We plan to explore other thera­peutic modalities with the PLE and seek part­ner­ships with pharma­ceu­tical and bio­technol­ogy com­pa­nies interested in uti­liz­ing our tech­nology to poten­tially im­prove the de­livery and the ef­fi­cacy and tol­er­a­bil­ity of their drugs.”

The com­bi­na­tion of the PLE with a small mol­e­cule chemo­ther­a­peu­tic is known as a Phospholipid Drug Conjugate or PDC™. PDCs provide targeted de­livery and re­lease of thera­peutic pay­loads inside tumor cells in­clud­ing pri­mary and metastatic tumor sites as well as cancer stem cells and has also dem­onstrated the capacity to cross the blood-brain-barrier and target brain tumors.

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 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 cur­rently 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 19, 2020. The com­pany is also con­ducting a two-part Phase 1 dose-escalation with ex­pan­sion arms in pedi­atric solid tumors and lym­phomas.

The com­pany’s prod­uct pipe­line in­cludes one pre­clin­i­cal PDC chemo­ther­a­peu­tic pro­gram (CLR 1900) and mul­ti­ple 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 Bio­sciences.