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Plus Therapeutics Announces Key RNL Development and cGMP Drug Manufacturing Collaboration Agreements

Nachrichtenquelle: globenewswire
04.05.2021, 13:30  |  105   |   |   

– Agreements are a major step for ongoing clinical trials and future commercial drug supply

AUSTIN, Texas, May 04, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced two collaboration agreements to support its process development and analytical chemistry activities for the cGMP manufacturing of Rhenium NanoLiposome (RNL), the Company’s lead investigational asset in clinical development for recurrent glioblastoma.

Plus Therapeutics signed a pre-clinical, clinical, and process development agreement with Invicro LLC (Invicro), a Konica Minolta company, a global provider of imaging biomarkers, core lab services, advanced analytics and software solutions for drug discovery and development with best-in-class expertise in radiochemistry. Under this agreement, Invicro will characterize the current manufacturing process and develop in-process manufacturing controls for the RNL active pharmaceutical ingredient (API) and final drug product and provide future clinical trial imaging support and drug development consulting.

In addition, Plus Therapeutics entered into an agreement with Eurofins BioPharma Inc. (“Eurofins”), a market leader in analytical chemistry for discovery pharmacology and advanced materials sciences. Eurofins will develop and validate test methods for purity, composition, and identity of Re-BMEDA, the API in RNL. These test methods will support release testing and compliance with cGMP requirements for new drug substances.

“Process optimization and appropriate quality controls of investigational compounds are very critical aspects in bringing novel drugs to markets,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “We have identified two best-in-class partners in Invicro and Eurofins to help us get one step further in bringing RNL to a registrational clinical trial and ultimately commercial supply.”

As previously disclosed, Plus Therapeutics entered into a master services agreement with Piramal Pharma Solutions for the development, manufacture, and supply of RNL intermediate of the drug product.

About Plus Therapeutics, Inc.

Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

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Plus Therapeutics Announces Key RNL Development and cGMP Drug Manufacturing Collaboration Agreements – Agreements are a major step for ongoing clinical trials and future commercial drug supplyAUSTIN, Texas, May 04, 2021 (GLOBE NEWSWIRE) - Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing …

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