Manufacturing Master Service Agreement signed to further development of a non-antiretroviral on- demand HIV prevention product.
GENT, Belgium — September 8, 2023 - SwiftPharma, a Belgium-based manufacturer, and the Population Council, a global nonprofit research organization, have signed a Manufacturing Master Service Agreement for the plant- based manufacture of Griffithsin to further the Council’s development of a Griffithsin fast-dissolving vaginal insert for protection against HIV.
The Population Council has been developing a non-antiretroviral HIV-prevention method containing Griffithsin (GRFT) in a fast-dissolving insert (FDI). This Griffithsin FDI is an on-demand, user-controlled, portable prevention technology in early development that is designed to be manufacturable in low- and middle-income countries.
A user would insert the FDI prior to sex, at which point the FDI would begin to quickly dissolve and blend with the vaginal fluids to coat the inside of the vagina with Griffithsin to provide protection against HIV infection for up to 12 hours. Griffithsin is a non-antiretroviral HIV entry inhibitor that binds to the HIV envelope glycoproteins and blocks virus entry into target cells. In addition to HIV prevention, preclinical studies have also shown effective prevention against HSV-2 and HPV, and early clinical evaluations have demonstrated an excellent safety profile when delivered as a gel, a precursor product to the FDI.
“This agreement will allow us to efficiently manufacture Griffithsin at the high level of quality needed for the clinical development of this innovative HIV prevention product,” said Dr. Lisa Haddad, Principal Investigator of the project and Medical Director at the Population Council Center for Biomedical Research. “On-demand methods of HIV and STI protection are limited to condoms, for which many people struggle with consistent use. To expand the HIV prevention landscape, more easy-to-use self-administered products are urgently needed.”
“Our HyperXpress manufacturing process signifies a pivotal leap in sustainable biomanufacturing. The utilization of Nicotiana benthamiana plants offers a remarkably efficient and scalable solution for low-cost biomanufacturing. This development holds immense promise in the fight against the HIV epidemic, especially for regions with limited resources, and underscores our unwavering dedication to innovation, sustainability, accessibility, and global health improvement,” said Jeroen Hofenk, SwiftPharma’s Founder and Chief Science Officer.
This work is funded by the German Federal Ministry of Education and Research through the KfW Development Bank and MATRIX, a United States Agency for International Development (USAID) Project to Advance the Research and Development of Innovative HIV Prevention Products for Women. Building on favorable outcomes in in vivo models, the current funding will support research to advance the FDI through preclinical studies for its primary indication for HIV prevention, development of a final formulation, and evaluation in Phase 1 trials.
MATRIX is made possible by the generous support of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID). The contents in this press release are those of the Population Council and SwiftPharma and do not necessarily reflect the view of the U.S. President’s Emergency Plan for AIDS Relief, the U.S. Agency for International Development or the U.S. Government.
About SwiftPharma SwiftPharma is a Belgium-based privately held biotechnology company dedicated to developing next generation, animal-free, and affordable recombinant proteins by transforming plants into mini bioreactors. The company is on a mission to bring a paradigm shift to multiple industries by serving as a bridge between high unmet industry needs and the significant advances being made in sustainable biomanufacturing. For more information, visit www.swiftpharma.eu.
About the Population Council The Population Council is a leading research organization dedicated to building an equitable and sustainable world that enhances the health and well-being of current and future generations. We generate ideas, produce evidence, and design solutions to improve the lives of underserved populations around the world. Learn more at www.popcouncil.org.