CLR-121225 / Cellectar - LARVOL DELTA

2026 Strategic Initiatives (Cellectar Biosciences Press Release) - "Enroll patients in the Phase 1b study of CLR 125 in TNBC with interim data expected in mid-2026...Prepare actinium-based CLR 225 for first-in-human trials in pancreatic cancer....Progress additional PDC-based radiotherapeutics into preclinical and IND-enabling studies."

Enrollment status • First-in-human • New trial • P1 data • Pipeline update • Pancreatic Cancer • Triple Negative Breast Cancer

Preclinical Data in Poster Presentation at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer Research (GlobeNewswire) - "The poster highlighted preclinical data from CLR 121225 (CLR 225), the Company’s novel actinium-based radio conjugate alpha-emitter for treatment in pancreatic ductal adenocarcinoma (PDAC)....CLR 225 (225Ac-phospholipid ether) demonstrates meaningful inhibition of tumor growth and potential survival benefit in three pancreatic cancer xenograft models."

Preclinical • Pancreatic Ductal Adenocarcinoma

Targeting Lipid Rafts in Hypoxic Pancreatic Ductal Adenocarcinoma: Preclinical Evaluation of [225Ac]CLR 121225, a Novel Actinium-Based Radio-Conjugate Free (AACRPanCa 2025) - "Unlabeled CLR 225 exhibited predictable PK and safety in all species, including multiple doses in dogs. These preclinical results support further development."

Preclinical • Fibrosis • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Cellectar Biosciences and ITM Enter Supply Agreement for GMP-Grade Actinium-225 (GlobeNewswire) - "The agreement will support the clinical development of Cellectar’s actinium-labeled phospholipid ether (PLE) radiopharmaceutical candidates, including its Phase 1-ready compound, CLR 121225, for the treatment of solid tumors...Under the terms of the agreement, ITM will supply Cellectar with the required quantities to facilitate the clinical development of its therapeutic medical grade radioisotope, Ac-225, produced by Actineer Inc., the joint venture between ITM and Canadian Nuclear Laboratories."

Commercial • Solid Tumor

Cellectar Biosciences to Present Data in Poster Presentation at the American Association for Cancer Research Special Conference on Advances in Pancreatic Cancer Research (GlobeNewswire) - "The poster presentation will highlight preclinical data from CLR 121225, the Company’s novel actinium-based radio conjugate alpha-emitter for treatment in hypoxic pancreatic ductal adenocarcinoma."

Preclinical • Pancreatic Cancer

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 Reports First Quarter 2025 Financial Results and Provides a Corporate Update (GlobeNewswire) - "In a series of pre-clinical studies evaluating CLR 121225, the company’s lead alpha-emitting actinium-225 PRC in refractory pancreatic models, desired pharmacokinetics, biodistribution and activity were observed, further supporting future clinical development."

Preclinical • Pancreatic Cancer

NorthStar Medical Radioisotopes Executes Supply Agreement With Cellectar Biosciences for Therapeutic Radioisotope Actinium-225 (Ac-225) (Businesswire) - "NorthStar to provide non-carrier added actinium-225 (n.c.a Ac-225) to Cellectar for use in its expanded portfolio of clinical programs; This includes CLR 121225 an actinium-labeled phospholipid ether (PLE), expected to enter a Phase 1 study in pancreatic cancer in 2025."

Commercial • New P1 trial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Cellectar Biosciences and NorthStar Medical Radioisotopes Announce Partnership for Supply of Actinium-225 (GlobeNewswire) - "Cellectar Biosciences...announced the signing of a strategic supply agreement with NorthStar Medical Radioisotopes, LLC, for the procurement of NorthStar’s non-carrier added (n.c.a.) Ac-225. The Company’s CLR 121225 development program combines its proprietary Phospholipid Ether (PLE) delivery platform and actinium 225 for the treatment of solid tumors...'We plan to advance CLR 121225 into human clinical trials in 2025 as part of a broader strategy to bring first-and best-in-class radiotherapeutics to market. This agreement with NorthStar provides a reliable source of Ac-225, which is a critical to our clinical development strategy.'....The agreement provides supply of Ac-225 from NorthStar for 10 years, and initiation is expected to occur in 2025."

Commercial • New trial • Oncology • Solid Tumor