REC604b – Early-Stage HPV Vaccines
Formulated with Novel AdjuvantSupported by our strong technology platforms, we are exploring opportunities to develop HPV vaccines formulated with novel adjuvant, namely REC604a and REC604b. Unlike the traditional alum adjuvant we are currently using, we are conducting early-stage development of next-generation HPV 9-valent and quadrivalent vaccines formulated with a novel self-developed adjuvant, benchmarking AS04. Based on existing studies, compared to Merck’s Gardasil, GSK’s AS04-adjuvanted Cervarix has demonstrated strong cross-protection effectiveness with higher titers of neutralizing antibodies in clinical trials, suggesting that novel adjuvants can enhance the immunogenicity of HPV vaccines. As the introduction of novel adjuvant enhances immunogenicity profile of REC604a and REC604b, they are designed to adopt a two-shot regimen. In an animal study conducted in mice, REC604a with a two-shot dosing has demonstrated its non-inferiority in terms of GMT level and immune persistence of serum neutralizing antibody as compared to Gardasil with a three-shot dosing.
We are currently developing REC604a and REC604b. We plan to submit the IND application to the NMPA for REC604a in 2022 and REC604b in 2023, respectively.