Plus Therapeutics, Inc. (PSTV) stock soared 35.66% in the current-market trading session at the price of $1.48 after it achieved two significant milestones toward cGMP manufacture of its Rhenium-186 NanoLiposome. PSTV is a clinical-stage pharmaceutical firm that develops and commercializes innovative therapeutics to treat cancer and other life-threatening diseases.
PSTV Achieved Significant Milestones Regarding Rhenium-186
On 4th January 2022, PSTV reported achieving two notable milestones as it advances toward the cGMP manufacture of its Rhenium-186 NanoLiposome. Let’s discuss both of the developments one by one.
MSA with IsoTherapeutics
Firstly, the company has signed a master services agreement with IsoTherapeutics Group LLC. The agreement aims to develop and deliver cGMP grade Rhenium-186 isotope for PSTV’s Rhenium-186 investigational radiotherapeutic. This deal will ensure Rhenium-186 meets U.S. FDA provisions for use in late-stage clinical trials.
Under the contract, IsoTherapeutics will devise a synthesis methodology, stability studies, and test method development as well as synthesize cGMP Rhenium-186. PSTV expects this MSA leads to commercial supply agreements with IsoTherapeutics for the drug development stage. This deal will also support PSTV’s cGMP supply sustainability scheme.
Completion of Analytical Test Method
Additionally, the company has completed the transfer of analytical test methods with PPS for the Rhenium-186 intermediate drug product. The agreement aimed to manufacture and supply the Rhenium-186 intermediate drug product. It is a notable juncture as the company advances towards the process transfer of cGMP intermediate drug products. As earlier announced, PSTV joined a master services agreement with Piramal Pharma Solutions in early 2021.
President and Chief Executive Officer of PSTV, Marc Hedrick, commented that this is a significant step towards their goal to ensure the availability of Rhenium-186 by mid-2022. It will help them achieve their continued clinical trials in patients with recurrent glioblastoma or leptomeningeal metastases. They are excited to have a strategic partnership with a proficient radiopharmaceuticals technology, IsoTherapeutics. Their comprehensive expertise matches what PSTV was looking for in a manufacturing partner.