On July 27, 2021 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 entered into an exclusivity agreement with ABX Advanced Biochemical Compounds GmbH (ABX) for the supply of a key component required to manufacture the drug substance in Rhenium-186 NanoLiposome (186RNL), the Company’s lead radiotherapeutic (Press release, Cytori Therapeutics, JUL 27, 2021, View Source [SID1234585439]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In parallel to our clinical progress, we are simultaneously strengthening our commercial RNL supply chain for long-term success", said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "ABX has extensive experience manufacturing and supplying chemical components for the radiopharmaceutical industry and exclusivity provides us an additional layer of market protection around our RNL portfolio."
As part of the agreement, ABX will produce a high purity precursor that meets current Good Manufacturing Practices (cGMP) and all relevant requirements of the U.S. Food and Drug Administration and other similar global regulatory entities. Plus Therapeutics will have up to 10 years of exclusive access to the cGMP precursor. This strategic partnership secures the commercial supply chain for 186RNL and extends to future products under the RNL platform.
186RNL is being developed to potentially treat recurrent glioblastoma and other rare and difficult-to-treat cancers. Plus Therapeutics is currently enrolling patients with recurrent glioblastoma in the U.S. multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial which is designed to safely, effectively and conveniently deliver high doses of radiation directly to brain tumors.