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Plus Therapeutics Announces Two Significant Milestones Toward cGMP Manufacture of its Lead Investigational Radiotherapeutic
IsoTherapeutics Group LLC to develop and supply cGMP grade Rhenium-186 isotope for Plus Therapeutics’ Rhenium-186 NanoLiposome (186RNL) radiotherapeutic Plus
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"IsoTherapeutics Group LLC to develop and supply cGMP grade Rhenium-186 isotope for Plus Therapeutics’ Rhenium-186 NanoLiposome (186RNL) radiotherapeutic Plus Therapeutics completes technology transfer of analytical test methods with Piramal Pharma Solutions for 186RNL drug product intermediate AUSTIN, Texas, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it has met two significant milestones as it progresses toward cGMP manufacture of Rhenium-186 NanoLiposome (186RNL). The Company has entered into a master services agreement (MSA) with IsoTherapeutics Group LLC for the development, manufacture and supply of current Good Manufacturing Practices (cGMP) grade Rhenium-186 isotope for the Company’s 186RNL investigational radiotherapeutic. This agreement will help ensure Rhenium-186 meets U.S. Food and Drug Administration requirements for use in late-stage clinical trials. Under the MSA, IsoTherapeutics will develop a synthesis process and in-process manufacturing controls, test method development and validation, stability studies, as well as manufacture cGMP Rhenium-186. The Company anticipates that the MSA will lead to clinical and commercial supply agreements for the drug product with IsoTherapeutics at the appropriate stage of development. This agreement will strengthen the Company’s long term cGMP supply sustainability strategy, as it will own the intellectual property rights for the manufacturing and testing of the Rhenium-186 target. Additionally and importantly, Plus Therapeutics completed the technology transfer of analytical test methods with Piramal Pharma Solutions (PPS) for 186RNL drug product intermediate. This is an important milestone as it precedes the completion of the process transfer and the manufacturing of cGMP drug product intermediate. As previously disclosed, Plus Therapeutics entered into a MSA with PPS in early 2021 for the development, manufacture and supply of Plus Therapeutics’ 186RNL intermediate drug product. “These are important steps towards our goal to confirm fully compliant 186RNL available by mid-2022 for our ongoing clinical trials in adults with recurrent glioblastoma, leptomeningeal metastases and other life...