Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of virus-based products, 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. Financial terms were not disclosed.
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 of HIV. 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, like HIV, where no vaccine has yet been identified. It will manage process development and optimization activities for one year, after which it will support the launch of cGMP manufacturing for phase II clinical trials.
“We are very happy that Sumagen’s HIV vaccine project, which had been delayed due to the COVID-19 pandemic, has resumed. As this is the long-awaited resumption of production, we will make every effort to initiate phase II clinical trials as soon as possible,” said Jung-Gee Cho, CEO of Sumagen.
“As Sumagen’s 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.”
“We are honored that Sumagen trusts us to develop and manufacture its HIV vaccine candidate, which has the potential to be the first HIV-1 vaccine to achieve market authorization,” said Eric Le Forestier, general manager of Naobios. “With our years of expertise in the development and production of viral vaccines, we are confident that we can support Sumagen through the next stages of its clinical development.”