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.
- Related: Plus Therapeutics’ Targeted Radiotherapy Shows Encouraging Overall Survival In Brain Tumour Trial.
- 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.
- Price Action: PSTV shares are up 48.50% at $1.62 during the premarket session on the last check Tuesday.
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