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    • Dec 12, 2023

Production of PRIMVAC kicked off at GTP Bioways

Toulouse, October 2023

A face-to-face meeting was held in October in Toulouse, France, to kick-start the production of the VAR2CSA-based protein vaccine candidate, PRIMVAC, at GTP Bioways. The meeting brought together collaborators from INSERM (inventor of the vaccine), European Vaccine Initiative (EVI) and GTP Bioways to discuss project governance, work packages, ongoing activities, and plan for the next steps. The meeting ended with a tour of GTP Bioways’ facilities, including the brand-new manufacturing suite where PRIMVAC will be produced.

PRIMVAC is a prophylactic vaccine intended for prevention of placental malaria, a severe disease that affects pregnant women in malaria-endemic regions, leading to poor health outcomes in both mother and child. The vaccine was shown to be safe and immunogenic in a previous first-in-human, phase 1a/1b study conducted in 2016 in France and Burkina Faso, where up to 100 µg of the vaccine were tested in combination with two different adjuvants.

In the perspective of continuing the clinical development of this promising vaccine candidate, a new good manufacturing practice (GMP) lot will be manufactured in 2024, after completing the transfer of the current manufacturing process to GTP Bioways. The involvement of the contract manufacturing organisation with PRIMVAC dates back to 2013, with the initial development of the vaccine’s manufacturing process in Escherichia coli. With the opening of their new GMP manufacturing suite, the team is now committed to help move forward PRIMVAC to the next clinical stage. The upcoming vaccine lot will be used in several planned clinical studies that will be conducted in the Netherlands, Burkina Faso and Benin (see more: Advance_Vac4PM, Vac4PM), sponsored by both INSERM and EVI.

We are all looking forward to seeing the project unfold over the coming months, towards the start of the new clinical trials, bringing PRIMVAC one step closer to the women who need it and hopefully leading to an essential breakthrough in the fight against placental malaria, says Flavia D’Alessio, Senior Project Manager at EVI.

 

Contact details:

Dr. Flavia D’Alessio (Project Leader)

 

 

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.


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