Clinical Trial Results - Iopofosine I 131 demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% in the CLOVER-WaM study, exceeding the primary endpoint of a 20% MRR [1] - The results were presented at the 66th Annual American Society of Hematology Conference in December 2024 [1] Product Pipeline - The company's lead asset is iopofosine I 131, a Phospholipid Drug Conjugate (PDC) designed for targeted delivery of iodine-131 [7] - Other pipeline assets include CLR 121225 (actinium-225 based program) and CLR 121125 (iodine-125 Auger-emitting program) targeting solid tumors [7] - The company is advancing radioconjugate PDC programs, including alpha- and Auger-emitting radioconjugates, into Phase 1/2a solid tumor studies [8] Regulatory and Market Strategy - Iopofosine I 131 has received six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA [4] - The company is pursuing conditional U.S. market approval through the FDA's accelerated approval process and aligning with the European Medicines Agency for global approval [5] - A confirmatory study with 40-60 patients per arm is expected to be completed within 18 months of the first patient enrollment [5] Strategic Initiatives - The company plans to advance iopofosine I 131 through internal development, strategic partnerships, and other approaches [8] - CLR 121225, an alpha-emitting actinium-225 radioconjugate, has shown activity in pancreatic, colorectal, and breast cancer animal models, with an IND application planned for Q1 2025 [9] - The company is evaluating the timing of study initiation for both CLR 121225 and CLR 121125 [6] Corporate Updates - The company will present its 2025 strategic initiatives at the Biotech Showcase during the 43rd Annual JP Morgan Healthcare Conference in January 2025 [8] - A live webcast and replay of the presentation will be available on the company's investor relations website [10]
Cellectar Biosciences to Highlight 2025 Strategic Initiatives at Upcoming Biotech Showcase during the JP Morgan Healthcare Conference