Sirnaomics and Precision NanoSystems Inc. (PNI) jointly announced a partnership on the development and manufacture of Sirnaomics polypeptide nanoparticle-based RNAi therapeutic product. This strategic joint effort includes the execution of a NanoAssemblr® platform license and supply agreement, plus successful production of multiple batches of Sirnaomics drug product candidates, STP705 and STP707, for ongoing IND enabling safety and toxicity studies, as well as several clinical studies.
Sirnaomics is a clinical stage biopharmaceutical company specialized in RNAi-based therapeutics for addressing the unmet needs in treatment of cancers and fibrosis diseases. The company has developed proprietary polypeptide nanoparticle carriers for efficient siRNA delivery, to advance an enriched drug product pipeline. Sirnaomics' lead product candidate, STP705, is an siRNA (small interfering RNA) therapeutic which takes advantage of a dual-targeted inhibitory property together with a polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of Cholangiocarcinoma, Non-Melanoma skin cancer and Hypertrophic Scar. STP705 has also received Orphan Drug Designation for treatment of Cholangiocarcinoma, Primary Sclerosing Cholangitis and Hepatocellular Carcinoma. A recent interim analysis report of a phase IIa clinical study on STP705 for treatment of Squamous Cell Carcinoma in situ indicated the topline therapeutic results with complete histological clearance tumor cell on treated sites. Using the same dual targets design, Sirnaomics has further developed STP707, a systemic formulation with broader application potential.
"As the leader in RNAi therapeutics specialized in polypeptide nanoparticle formulation, we are so excited to see the further advancement of our process development and large scale product manufacturing, using PNI's NxGen™ microfluidic technology. In working with PNI's team and the NanoAssemblr platform, we were able to establish a robust manufacturing process from a nominated drug candidate to GMP manufacturing in just a few months, greatly accelerating our drug development process". Sirnaomics is currently using these batches produced with NxGen™ for non-human primate safety toxicity studies and clinical studies," Sirnaomics' founder, president and CEO, Dr. Patrick Lu said.
"We are pleased to support Sirnaomics, an innovative RNAi therapeutics company, with our NanoAssemblr platform and Clinical Solutions Team that helped take their drug program to a successful GMP batch manufacture. We believe the NanoAssemblr microfluidic technology enables exquisite control over the particle size, charge and encapsulation efficiency which was important for the performance of Sirnaomics' drug product candidates," Dr. James Taylor, co-founder and CEO of PNI said.
PNI's NanoAssemblr platform, with over 400 systems placed worldwide, is designed to enable drug developers to rapidly progress from R&D to industrial-scale nanomedicine manufacture.