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Sumagen Canada Inc, a biotech company based in both South Korea and Canada has partnered with CDMO Naobios to industrialise Sumagen’s human immunodeficiency virus (HIV)-1 vaccine candidate (SAV0001) at bench scale.
First of its kind in human vaccine trials, SAV001 is a whole-killed and genetically modified HIV vaccine. During phase 1 of the clinical trial, NCT01546818, the vaccine demonstrated safety for human use. The trial used 33 participants and results show that SAV001 triggered anti-HIV immune responses, which was reported back in 2016.
Dr Sangkyun Lee, president of Sumagen stated: “We are thrilled to have reached such a strategic industrial milestone within expected initial timelines, which is extremely significant due to the initial project delays resulting from the COVID-19 pandemic. This achievement solidifies our trust in Naobios to help our HIV-1 vaccine reach the crucial phase 2 trials, bringing us closer to delivering a vaccine to patients in need.”
The partnership agreement, which was signed in April earlier this year, stated terms of manufacturing that have been achieved by Naobios within the initial schedule. Both companies are focusing on industrial-scale up activities until mid 2025, which will be immediately followed by cyclic guanosine monophosphate (cGMP) production in order to support phase 2 of the trial, according to the press release.