CLR-121125 / Cellectar - LARVOL DELTA

Cellectar Biosciences, Inc. Enters Into Agreements to Raise $5.8 Million (Cellectar Biosciences Press Release) - "The company intends to use the net proceeds from the offering for working capital and general corporate purposes, its Phase 1b clinical study of our compound CLR 121125 (CLR 125) in triple-negative breast cancer, and the preparation and filing for a Conditional Marketing Authorization (CMA) with the European Medicines Agency."

Financing • Triple Negative Breast Cancer

Cellectar and Evestia Clinical Announce Partnership to Support Auger-Emitting Radiopharmaceutical Clinical Trial in Triple-Negative Breast Cancer (TNBC) (GlobeNewswire) - "Intends to Initiate Phase 1b Clinical Trial in TNBC at Mayo Clinic in Fourth Quarter 2025."

Commercial • New P1 trial • Triple Negative Breast Cancer

Oppenheimer 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit (GlobeNewswire) - "Provided data to EMA data from the Phase 2b CLOVER WaM clinical trial....Initiation of Phase 1b Dose Finding study of the company’s Auger-emitting radiopharmaceutical, CLR 125, for the treatment of relapsed triple-negative breast cancer (TNBC), planned for the fourth quarter 2025."

New P1 trial • Trial status • Triple Negative Breast Cancer • Waldenstrom Macroglobulinemia

Cellectar Biosciences Provides Strategic Update on Clinical Development, Pipeline Programs and Corporate Restructuring (GlobeNewswire) - "Due to recent communications with the...FDA...regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the Company has decided to pursue strategic options for the further development and commercialization of this product candidate....Based upon a recent Type-C meeting with the FDA, the Company now believes that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on PFS....The Company will now focus its resources on targeting solid tumors by advancing CLR 121225...and CLR 121125, its iodine-125 Auger-emitting program into the clinic. Cellectar expects to file Investigational New Drug applications in the first half of 2025 for both CLR-121225 and CLR-121125, which will allow the initiation of Phase 1 clinical studies in solid tumor cancers."

FDA event • IND • Pipeline update • Hematological Malignancies • Oncology • Solid Tumor

Cellectar Biosciences to Highlight 2025 Strategic Initiatives at Upcoming Biotech Showcase during the JP Morgan Healthcare Conference (GlobeNewswire) - "CLR 121225 is Cellectar’s lead alpha-emitting actinium-225 radioconjugate PRC...The Company plans to file an Investigational New Drug (IND) application in the first quarter of 2025....CLR121125 has received IND clearance and a Phase 1b/2a dose finding study in triple-negative breast cancer is planned."

IND • New P1/2 trial • Solid Tumor • Triple Negative Breast Cancer

Cellectar Biosciences Submits Phase 1b Clinical Trial Protocol to US Food and Drug Administration for CLR 125 to Treat Triple-Negative Breast Cancer (TNBC) (GlobeNewswire) - "Cellectar Biosciences...announced that the company has submitted a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1b Dose Finding study of its Auger emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC....The proposed Phase 1b dose finding study in relapsed TNBC will utilize imaging to determine tumor uptake to evaluate three doses of CLR 125 (32.75 mCi for 4 cycles, 62.5 mCi for 3 cycles, and 95 mCi for 2 cycles) with four doses per cycle in 15 patients per arm. The primary endpoint of the study will be to determine the recommended Phase 2 dose and dosing regimen and will also evaluate safety and tolerability, as well as initial response assessment (RECIST and progression-free survival)."

IND • New P1 trial • Triple Negative Breast Cancer

Cellectar Biosciences and U.S.-based Nusano Enter Into Multi-Isotope Supply Agreement (Cellectar Biosciences Press Release) - "Cellectar Biosciences...and Nusano...announced the signing of a multi-year supply agreement in which Nusano will provide Cellectar with iodine-125 (I-125) and actinium-225 (Ac-225) for its clinical studies and future commercial needs....'This agreement ensures uninterrupted access to these essential isotopes, providing the necessary clinical development supply for our innovative clinical stage programs, including CLR 125 for triple negative breast cancer and CLR 225 for pancreatic cancer.'"

Commercial • Pancreatic Cancer • Triple Negative Breast Cancer