Today, SAGEbio LLC received a very favourable and supportive response from the US-FDA as the regulatory agency in charge of the approval process of SAGEbio's vaccine development. Our thanks goe to the hard working experts at the FDA, which provide a very clear, helpful and encouraging guidance for the way forward.
Committing to its roots, SAGEbio is now also incorporated in the Kingdom. Transfer of Saudi-developed technologies to the KAUST-based biotech start-up SAGEbio, which will take over responsibilities and operations from first in-human administration onwards will enable a rapid development to market strategy.
The team has secured support from GenScript-ProBio as a co-developer to advance its vaccine-candidate into the clinical stage. GenScript-ProBio will contribute international experience from related projects and utilize its network to facilitate pre-clinical development and to enable fast entry into clinical studies. Within the frame of a strategic partnership, GenScript-ProBio may provide knowledge and training for the localization of a respective vaccine production facility.
SAGEbio is now open for business after incorporation as an LLC in the United States. The company secured a presence right in the heart of the world’s most prolific biotechnology and health tech hub. The office located in the CIC building in Cambridge, Massachusetts is in walking distance to Boston’s the world leading universities and hospitals.
The KAUST team filed two US Provisional Patent Applications to strengthen the protection of the proprietary composition of its pan-Betacoronavirus vaccine, whcih is currently under development.
Today, the KAUST team lead by Prof. Magnus Rueping, Associate Director of the KAUST Catalysis Center was awarded a $2.5M Near Term Grand Challenge award to advance a pan-Betacoronavirus vaccine towards a pre-IND submission with the US FDA.
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