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Tuesday, January 4, 2022

Plus Hits Two Milestones To Manufacture Its Lead Radiotherapeutic

 Plus Therapeutics Inc (NASDAQ: PSTV) 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 to develop, manufacture, and supply Rhenium-186 isotope for its 186RNL investigational radiotherapeutic.

  • The agreement will help ensure Rhenium-186 meets FDA 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, and manufacture Rhenium-186.

  • Additionally, Plus Therapeutics completed the technology transfer of analytical test methods with Piramal Pharma Solutions (PPS) for 186RNL drug product intermediate.

  • As previously disclosed, Plus Therapeutics entered into an MSA with PPS in early 2021 to develop, manufacture, and supply Plus Therapeutics' 186RNL intermediate drug product.

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