The clinical-stage pharma company, Plus Therapeutics Inc (NASDAQ: PSTV), is known for developing targeted and innovative radiotherapeutics for complex and rare cancers. Last week, the company announced signing an exclusive agreement with ABX Advanced Biochemical Compounds GmbH. According to the agreement, the deal facilitates supplying critical components used in manufacturing drug substances in its lead radiotherapeutic product, 186RNL or Rhenium-186 NanoLiposome.
Clinical and commercial strength tightening
The CEO and President of the company, Marc H. Hedrick M.D., stated that apart from the clinical progress, the company is also parallelly strengthening its supply chain for commercial RNL. This is done in light of long-term success. The CEO also mentioned that ABX has extensive experience in supplying chemical components and manufacturing for the radiopharmaceutical industry. Exclusivity for Plus enables getting additional protection for the company’s RNL portfolio.
What’s the agreement?
As per the agreed terms, ABX is supposed to produce a purity precursor of the highest quality, which stands up to the Good Manufacturing Practices or cGMP. The same should also be relevant as per the U.S. Food and Drug Administration requirements, apart from global regulations. The company will have about a decade of exclusive rights for this cGMP precursor. In addition, the strategic partnership enables the company to secure 186RNL’s supply chain for ten years, which is extendable for future products as per the RNL platform.
186RNL is developed for the treatment of rare and challenging treatment cancers, including recurrent glioblastoma. The company is presently undertaking a clinical trial for ReSPECT™-GBM Phase 1 dose-finding and enrolling patients with recurrent glioblastoma cancer. The purpose of this clinical trial is to understand the convenience, efficiency, and safety of high doses of radiation that are directly given to the brain tumor site.
The company’s radiotherapeutic portfolio concentrates on nanoliposome-encapsulated radionuclides, which target a range of cancers.