Plus Therapeutics Successfully Completes Key Milestone for cGMP Manufacture of Lead Investigational Radiotherapeutic

On July 12, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it has reached a key milestone on the path to commercialization of Rhenium-186 NanoLiposome (186RNL) as the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions (PPS) (Press release, Cytori Therapeutics, JUL 12, 2022, View Source [SID1234616607]). Additionally, the intermediate drug product is in stability testing and compliant with U.S. Food and Drug Administration (FDA) guidance for manufacture of liposomal products for use in late-stage clinical trials and commercialization.

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In early 2021, Plus Therapeutics entered into a master services agreement with PPS for the development, manufacture and supply of the Company’s 186RNL drug intermediate product and has now completed the associated technology transfer of analytical test methods and development activities with PPS.

"The Company has met another significant CMC milestone by having fully compliant 186RNL intermediate, and is on time and on budget to have GMP drug availability in the second half of 2022 for ongoing and planned clinical trials in adults with recurrent glioblastoma, leptomeningeal metastases and future disease targets," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Furthermore, in the third quarter of 2022, we plan to issue specific guidance on feedback obtained from two FDA meetings, one based on potential acceptability of Plus Therapeutics’ CMC package and one for feedback on our future plans for clinical development of 186RNL for recurrent glioblastoma."