Plus Therapeutics Inc. (NASDAQ: PSTV) has announced that it has attained two significant milestones as it advances towards current Good Manufacturing Practices (cGMP) production of Rhenium-186 NanoLiposome (186RNL). The company’s nanotech platform focuses on delivering various drugs through the proprietary liposomal encapsulation tech.
Plus Therapeutics enters master service contract for 186RNL production
For the development, production, and distribution of cGMP standard Rhenium-186 isotope for Plus Therapeutics’ 186RNL experimental radiotherapeutic, the company has entered into a master service contract with IsoTherapeutics Group LLC. The contract will help guarantee Rhenium-186 meets FDA standards for utilization in late-stage clinical studies in the United States. In addition, IsoTherapeutics will design a method for the synthesis and in-process production controls, as well as create and validate test methods, conduct stability studies, and manufacture cGMP Rhenium-186 under the MSA.
At the relevant stage of development, the company expects that the MSA will result in commercial supply and clinical contracts for the drug candidate with IsoTherapeutics. In addition, the company’s long-term cGMP supply sustainability plan will be strengthened by this arrangement since it will own the IP rights for the Rhenium-186 product candidate’s production and testing.
CEO and President of Plus Therapeutics, Marc Hedrick, said, “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 cycle management trials. We are delighted to develop a strong, effective collaboration with IsoTherapeutics, a company with extensive capabilities in radiopharmaceuticals technology and development. Their demonstrated expertise is precisely what we are looking for in a manufacturing partner.”
Plus Therapeutics concluded analytical testing tech transfer for 186RNL
Plus Therapeutics also concluded the tech transfer of analytical testing methods for the 186RNL medicinal product intermediate with Piramal Pharma Solutions (PPS). This is a significant milestone because it comes before the technology transfer and the production of cGMP drug candidate intermediates. Plus Therapeutics and PPS signed a Memorandum of Understanding (MSA) in early last year for the development, production, and distribution of Plus Therapeutics’ 186RNL intermediate drug substance, as previously revealed.
