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AdaptVac announces a collaboration with GTP Bioways to manufacture its cVLP based placental malaria vaccine

 

Copenhagen, Toulouse – June 20, 2024. AdaptVac, a Danish clinical-stage biotech company, is announcing a collaboration with GTP Bioways, a leading French CDMO, for the production of a GMP batch of a placental malaria vaccine (PAMVAC) that will be used for a phase 1 clinical trial.  This innovative vaccine aims at reducing the number of doses needed and improving the longevity of the vaccine-induced immune response for placental malaria.

AdaptVac was founded on a ground-breaking capsid Virus-like Particle (cVLP) platform technology invented at the University of Copenhagen. The company aims to accelerate the development of long-lasting, highly efficient therapeutic and prophylactic vaccines. By presenting antigens in a repetitive, unidirectional manner on a capsid particle, the antibody response is focused towards the functional epitopes of the antigen. The technology can leverage many sub-unit antigens. An initial proof of concept was achieved with a SARS-CoV-2 RBD vaccine (NCT05329220), and the PAMVAC candidate is poised to build upon this success. The antigen is composed of the functional domain of the placental malaria antigen VAR2CSA.

After successful development of the bioprocess by AdaptVac, the industrial manufacturing process is currently being transferred to GTP Bioways’ GMP facilities. Right after, the manufacturing of the drug substance followed by aseptic filling of the final product into vials will be performed.

Morten Agertoug Nielsen COO of AdaptVac: “GTP Bioways is a key partner in enabling us to get to the clinic meeting a significant unmet need. With the hope that the vaccine will be subject to further evaluation in phase 2 and beyond, we believe this will become a long-term partnership. With the hope that the vaccine will be subject to further evaluation in phase 2 and beyond, we believe this will become a long-term partnership.”

Alain Sainsot, president of GTP Bioways CDMO declared: “GTP Bioways is proud to support the advancement of innovative therapies, such as this vaccine, into the clinical stage through its cGMP production capabilities. This partnership underscores the French industry’s capacity to offer solutions to address unmet global health needs, like placental malaria.”

Co-funding from the European Union (under the Horizon Union project ADVANCE_VAC4PM – N° 101057882), the Japanese Global Health Innovative Technology (GHIT) Fund and The Netherlands Enterprise Agency -Rijksdienst voor Ondernemend Nederland (RVO) were successfully mobilised by AdaptVac and its collaborator, the European Vaccine Initiative (EVI), to ensure the GMP manufacturing of the PAMVAC-cVLP vaccine candidate. The forthcoming vaccine batch will be used in clinical studies, scheduled in 2025, to be conducted in The Netherlands (Radboud UMC), Benin (FORS) and Burkina Faso (GRAS), within the ADVANCE_VAC4PM project and under the EVI’s sponsorship .

About AdaptVac

AdaptVac was founded in 2017. Based on a ground-breaking capsid Virus-like Particle (cVLP) platform technology invented at the University of Copenhagen, we aim to accelerate the development of long-lasting, highly efficient therapeutic and prophylactic vaccines within high value segments of oncology, infectious diseases, and immunological disorders. Apart from high commercial value assets, we are also involved in equitable access vaccine development. The company is owned by NextGen Vaccines ApS (66%) and ExpreS2ion Biotechnologies ApS (34%).

About GTP Bioways CDMO

GTP Bioways is a Contract Development and Manufacturing Organisation (CDMO) offering comprehensive manufacturing services to support biopharmaceutical companies from pre-clinical trials to commercial production of their innovative therapies.
GTP Bioways’ expertise spans the development of industrial processes and the manufacturing of biological molecules using both mammalian and microbial hosts, as well as bioconjugates and nanoformulated drugs. GTP Bioways is one of the few CDMOs to cover the entire biotherapeutics development value chain with integrated services that range from cell line/strain development to aseptic filling.
GTP Bioways operates four sites in France and employs 150 people. The company expects to generate a turnover of 23 million euros in 2024.
For further information: www.gtp-bioways.com | LinkedIn: @GTP-Bioways-CDMO