MinervaX and Wacker Biotech partner to scale up GBS vaccine production

The Danish biotech company MinervaX and the German contract development and manufacturing organization (CDMO) Wacker Biotech will be working together on MinervaX’s prophylactic vaccine against Group B Streptococcus (GBS) infections. Under the collaboration agreement, Wacker Biotech will be responsible for manufacturing the active protein ingredients of the vaccine, while also taking over key functions to ensure supply for late-stage clinical trials and a potential commercial launch.

GBS is a type of bacteria commonly found in the gastrointestinal and genital tracts of humans. While the bacteria are usually not harmful, they can cause life-threatening infections in newborns and older adults. Colonization by GBS in pregnant persons can result in premature delivery, stillbirth, or other adverse pregnancy outcomes when the bacteria are passed on to the fetus in the womb.

GBS can also be transferred to the newborn during delivery or in the first three months of life and can cause life-threatening infections, such as sepsis, pneumonia, and meningitis. Children who have suffered from a GBS infection may develop severe morbidity or long-term disability.

In many countries, pregnant persons are screened for GBS bacteria and treated with antibiotics before the baby is delivered. However, there is currently no vaccine to prevent GBS infections in newborns or older people.

“GBS can be life-threatening for newborn babies and is linked to over half a million preterm births annually,” said Per Fischer, CEO of MinervaX in a press statement.

“[...] Our team is advancing the development of our novel prophylactic vaccine against GBS for the benefit of all populations at risk, worldwide. Wacker Biotech is a robust manufacturing partner with a strong track record in late clinical and commercial supply and we look forward to collaborating with the team…”

The manufacturing collaboration comes ahead of preparations to begin phase 3 clinical trials for the AlpN GBS vaccine in pregnant women after MinervaX raised €54 million in financing last year. As the company’s new manufacturing partner, Wacker Biotech has experience in late-stage clinical and commercial manufacturing.

In a statement to BioPharma Reporter, Guido Seidel, managing director at Wacker Biotech said of the collaboration: “We are pleased to contribute to this important program and support MinervaX in bringing their lead prophylactic vaccine targeting Group B Streptococcus to the market.”

“With our new 350L and 1500L production line in Amsterdam and our highly experienced team, we will ensure that the necessary CMC activities, like process transfer, scale up, process characterization and analytical as well as process validation, will be successful. We work efficiently together with our client by using agile project management tools and a project core team which ensures that major milestones are met. As an experienced CDMO, we’ve supported the transition from clinical to commercial phase many times - MinervaX can rely on this expertise to bring their new drug to the market safely, effectively, and as quickly as possible.”

The vaccine is a protein-only vaccine that is based on the fusion of two Alp protein domains called GBS-NN and GBS-NN2. Alp proteins (Alpha-like proteins) are found on the surface of GBS, which makes them promising vaccine candidates. The two domains used in MinervaX’s vaccine are the most common Alp serotypes and are found in 99% of clinical GBS cases.

Data from previous studies shows that the AlpN GBS vaccine has a promising safety profile in pregnant people and their newborns with high immunogenicity and active, protective antibodies. If successful, the vaccine would greatly reduce the need for antibiotics.

In addition to the phase 3 study in pregnant people, MinervaX is also conducting a phase 1 study to test the GBS vaccine in older persons.