Thursday, September 14, 2023
Curia, a leading company specializing in contract research, development, and manufacturing, has announced that its collaborator, Replicate Bioscience, has received FDA clearance for Investigational New Drug (IND) status for RBI-4000, a self-replicating (srRNA) rabies vaccine. Replicate Bioscience is the inaugural participant in a Phase 1 clinical trial utilizing clinical material developed through a partnership with Curia.
Curia played a pivotal role in the development, scale-up, and cGMP manufacturing of the active ingredient srRNA RBI-4000. This srRNA consists of approximately 10,000 bases, making it notably larger than traditional linear mRNA, and has presented historical challenges when it comes to scaling up for clinical development. Curia's development of the analytical method and qualification of the assays were crucial for the release of this srRNA molecule.
Christopher Conway, President of Research & Development at Curia, expressed pride in their pioneering role in producing this new class of srRNA technology and supplying the drug substance RBI-4000 srRNA to support Replicate's Phase 1 clinical trial. He emphasized Curia's commitment to offering advantageous solutions in the mRNA space, encompassing development through cGMP manufacturing.
This innovative class of srRNA vaccines offers several potential advantages compared to existing mRNA vaccines, including reduced dosage and enhanced tolerability. Furthermore, it opens doors for further RNA innovations in vaccines and therapeutics with fewer size-related restrictions.
Nathaniel Wang, Ph.D., Founder and CEO of Replicate, acknowledged the instrumental role of Curia in the development of a new class of self-replicating RNAs, which have the potential to deliver superior bioactivity, tolerability, and potency compared to other RNA technologies. He noted Curia's ability to develop a process for longer RNAs, enabling large-scale production with optimal yield, purity, and potency in support of Replicate's Phase 1 clinical trial.
Curia remains dedicated to being the partner of choice throughout the drug development lifecycle, offering a comprehensive range of services, including research and development, manufacturing, and commercialization support for small and large molecules, APIs, aseptic fill & finish, and laboratory tests.