Naobios, a CDMO (Contract Development and Manufacturing Organisation) providing GMP production of clinical batches of virus-based products, has announced the signing of a partnership with Sumagen, a Korean-Canadian biotechnology company developing an HIV-1 vaccine candidate, to manage the manufacturing process during its phase II clinical trials.
At the end of 2022, the World Health Organization (WHO) reported that approximately 39 million people were living with HIV.
Developing an HIV vaccine has been one of the most difficult challenges in medical research, as it requires blocking a huge number of genetically variable forms.
Naobios will manage the manufacturing process of Sumagen’s whole-inactivated HIV vaccine candidate to confirm its safety and efficacy in a Phase I clinical trial and perform further process development to prepare the HIV-1 vaccine for phase II clinical trials.
With its BioSafety Level 3 (BSL3) production site, Naobios has the capability to support the development and production of vaccines for highly pathogenic viruses such as HIV, where no vaccine has yet been identified.
It will manage process development and optimisation activities for one year, after which it will support the launch of cGMP manufacturing for phase II clinical trials.
“As our AIDS vaccine requires very sophisticated technology and a high biosafety level facility, it was very difficult to find a company that could produce it,” said Dr Sangkyun Lee, in charge of research and development at Sumagen. “With Sumagen’s know-how and Naobios’ experience, I am confident that we will be successful in clinical sample production. I am highly encouraged by the resumption of the project and the partnership with Naobios.”
