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Abera Bioscience AB. (3/29/22). "Press Release: Abera Bioscience Signs Agreement with NorthX Biologics for GMP Manufacturing".

Organisations Organisation Abera Bioscience AB
  Organisation 2 NorthX Biologics Matfors AB
Products Product contract manufacturing (biologicals)
  Product 2 vaccine
Persons Person Alriksson, Maria (Abera Bioscience 202203 CEO)
  Person 2 Gidlund, Eva-Karin (NorthX Biologics 202203 Head of Alliance + Innovation)
     


Abera Bioscience (“Abera” or “Company”) is now taking the next big step in development towards clinical trials for its vaccine candidate against pneumococcus, Ab-01.12, by signing a collaboration agreement with NorthX Biologics for upscaling and GMP manufacturing. NorthX Biologics (“NorthX”) is a Swedish company with a focus on process development and large-scale production of advanced biological drugs and has also recently established an innovation hub to be able to support partners in achieving their goals in a more long-term way.

Abera Bioscience is a biotechnology company that develops vaccine candidates based on its proprietary vaccine platforms. The company’s main candidate, Ab-01.12, is a universal vaccine against pneumococcus given as a nasal spray. According to previous communications, the company is preparing the vaccine candidate for clinical trials in humans, where scaling up the production process, manufacturing according to GMP (General Manufacturing Practices) and toxicological studies are important milestones.

Abera has now signed an agreement with NorthX Biologics for the manufacture of Ab-01.12 according to GMP for use in clinical studies. Verification of the process is planned in an innovative collaboration between Abera, NorthX and Testa Center in line with the vision for the NorthX innovation hub and the government investment made in Swedish Life Science, which is supported by Vinnova. Testa Center is a test bed in bioprocess technology created by the government, Cytiva and Vinnova in order to give innovative companies a physical opportunity to test their processes before GMP production.

– After evaluating a number of players, it seemed natural to choose the Swedish company NorthX Biologics. They have more than 30 years of experience in GMP and manufacturing and they best met the requirements for knowledge, flexibility and ability to deliver that Abera sought. They are fast and cost effective. Together with NorthX, we have prepared a plan for accelerated development of Ab-01.12 where we expect to be able to initiate toxicological studies during Q4 2022 and hope to be able to submit our dossier and application to begin clinical studies Phase 1 for Ab-01.12 during the first half of the year 2023. NorthX innovation hub for vaccine development is an exciting initiative where we as a vaccine platform company already see several opportunities for different collaborations, says Maria Alriksson, CEO of Abera Bioscience.

– We at NorthX are proud of this collaboration agreement. Abera is exactly the kind of player we have strived to work with in our innovation hub – innovation-driven vaccine companies with a high level of research and knowledge of their own process, while they already have several exciting projects in the pipeline. Abera shines with ambition and has clear goals we would like to help them achieve. Abera’s vaccine platform with its plug’n’play technology is exciting and creates opportunities for several new vaccine projects in the future, says Eva-karin Gidlund Head of Alliance and Innovation at NorthX Biologics.

Ab-01.12 is a vaccine candidate against pneumococcus that is designed using an innovative technology to protect against all variants of the bacterium. Pneumococcus is a bacterium that in mild form causes ear infection and sinusitis but which also causes severe pneumonia, sepsis and meningitis. Pneumococci mainly affect children and the elderly and cause 1.5–2 million deaths per year, making this bacterial infection one of the most common causes of death for children under five worldwide. There are almost a hundred variants of the bacterium where today’s vaccine only protects against about twenty of these. Abera’s candidate Ab-01.12 is based on Abera’s vaccine platform BERA, where OMV (Outer Membrane Vesicles) is decorated with universal antigens from pneumococcus, which provides broader protection against the disease. The vaccine will be given as a nasal spray and has shown strong effect in pre-clinical studies by reducing the presence of bacteria in the nasal mucosa to one thousandth compared to unvaccinated. This efficacy shown in pre-clinical data for Ab-01.12 means that the bacterium is stopped already before it enters the body and causes disease.

   
Record changed: 2022-04-28

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