Curia Supports Replicate Bioscience’s Phase 1 Trial of RNA Vax

Replicate Bioscience has received IND clearance from the FDA and has dosed the first participant with RBI-4000, a self-replicating (srRNA) rabies vaccine, in a Phase 1 trial using clinical material developed as part of the collaboration with Curia, a contract research, development and manufacturing organization.
 
Curia conducted process development, scale-up and cGMP manufacture of srRNA RBI-4000 drug substance. At approximately 10,000 bases, this srRNA is significantly larger than a conventional linear mRNA and has been historically difficult to manufacture at the scales required for clinical development. Curia’s analytical method development and qualification of the assays were also critical to the release of this srRNA molecule.   
 
“Curia is proud to be a pioneer in manufacturing this new class of srRNA technology by delivering RBI-4000 srRNA drug substance to our partner Replicate in support of their Phase 1 clinical trial,” said Christopher Conway, President, Research & Development, Curia. “We are dedicated to providing advantaged solutions from development to cGMP manufacture for our customers in the mRNA field.”
 
This new class of srRNA vaccine offers a number of potential improvements to existing mRNA vaccines, including lower dosage requirements and improved tolerability. The advancement also opens the door for further RNA innovation for use in vaccines and therapeutics with fewer constraints on molecule size.
 
“Our collaboration with Curia helped us manufacture a new class of self-replicating RNAs which have the potential to deliver improved bioactivity, tolerability and efficacy profiles as compared to other RNA technologies,” said Nathaniel Wang, Ph.D., founder and CEO of Replicate. “Curia scaled up a process for longer RNAs that enabled large-scale production at yields, purity and potency to support Replicate’s Phase 1 clinical trial.”