Cerulean has created an extensive patent estate around its internally developed PNP technology with patent applications directed to multiple inventions in this area including, for example, inventions related to the composition and use of the PNPs and specialized apparatuses and methods for producing the PNPS.
Cerulean’s exclusive license to the patent estates of California Institute of Technology and Calando Pharmaceutical provides broad worldwide coverage of its CDP technology platform and various uses thereof. Additional Cerulean patent applications provide coverage related to improvements to and new applications of the CDP technology with a particular focus on IT-101, Cerulean’s lead product candidate and related inventions.
Nanopharmaceutical Development Capabilities
Cerulean has built a unique set of capabilities critical for nanopharmaceutical development. In its short history, the company has been able to generate a suite of homegrown technologies as well as in-licensed complementary technologies. These technologies have the capacity to incorporate different drug classes and have been validated in various pre-clinical cancer models. Cerulean has also generated a sophisticated set of analytical and bioanalytical tools critical for lead development and optimization of its nanoparticles.
Cerulean has developed robust clinical development experience by advancing one of the first nanoparticles into the clinic. IT-101 has shown to be safe in humans and has demonstrated that IT-101 overcomes the camptothecin toxicities and DMPK challenges which previously prevented the clinical development of free camptothecin. IT-101 has also demonstrated early evidence of clinical activity. The MTD will be established as part of the ongoing Phase 1b/2a clinical study.