Technology transfer for Corallopyronin A successfully completed with Phyton Biotech
This achievement exemplifies Phyton’s broad fermentation capabilities across different classes of microorganism.
Bioreactors for the production of Corallopyronin A at the HZI's Biotechnikum in Braunschweig. At Phyton Biotech, Corallopyronin A is now being produced on an industrial scale under Good Manufacturing Practice conditions for direct use in first-in-human clinical trials.
Phyton Biotech has successfully transferred the manufacturing process for the microbial production of Corallopyronin A (CorA). CorA is a novel anti-infective agent with the potential to address neglected tropical diseases. This achievement marks a significant step forward in the Company’s specialty GMP fermentation capabilities and supports the broader clinical development program led by the University Hospital Bonn (UKB), the Helmholtz Centre for Infection Research (HZI) and the German Center for Infection Research (DZIF).
CorA is a natural product anti-infective with a unique mechanism of action, showing potent activity against filarial infections such as river blindness (onchocerciasis) and lymphatic filariasis (LF), as well as against Staphylococci and the bacteria that cause community acquired pneumonia (CAP). The filarial infections are predominantly found in Africa (and in the case of LF, also in Asia), affect millions of people and are caused by parasitic worms that depend on bacterial symbionts. CorA selectively targets these symbionts, offering a promising therapeutic approach.
The technology transfer was successfully completed at the 1,500 L scale at Phyton Biotech’s GMP facilities near Hamburg, Germany (Fermentation) and in Vancouver, Canada (Purification). Key outcomes include:
• Robust fermentation of the genetically engineered Myxococcus xanthus strain.
• Efficient cell separation using tangential flow filtration (TFF).
• High-yield resin capture and purification of CorA, meeting all critical quality attributes.
"Completing the Corallopyronin A technology transfer marks an important milestone for Phyton Biotech and our partners," said Colin Marr, President of Phyton Biotech. "It highlights our comprehensive fermentation expertise including organism classes not broadly used in industry and our ability to support the scale-up of this novel therapy for clinical evaluation."
With the initial transfer process now complete, Phyton Biotech is preparing to demonstrate scalability and process performance at the 7,500 L scale to supply GMP quality CorA for upcoming clinical trials.
This project is part of a broader international collaboration supported by the DZIF and the Global Health Innovative Technology (GHIT) Fund from Japan through collaboration with the Japanese pharmaceutical company, Eisai Co. Ltd., aiming to advance CorA as a new treatment option for diseases that disproportionately affect underserved populations. Prof. Achim Hoerauf, principal investigator of the CorA development consortium and Director of the Institute of Medical Microbiology, Immunology and Parasitology at the University Hospital Bonn, emphasizes the importance of the DZIF and GHIT Fund in enabling the project to meet high international standards in preclinical development. "Through the DZIF and GHIT Fund, we were able to implement these standards within a consortium of academic institutions working alongside industrial partners—an achievement that would normally take many years," says Hoerauf, who is also deputy coordinator of the DZIF research area Malaria and Neglected Tropical Diseases.
The DZIF’s broad spectrum of expertise was key to the project’s success: the optimized heterologous production strain was developed at HZI under the leadership of DZIF scientist Prof. Rolf Müller. The production process, consisting of fermentation and purification, was also established at the HZI in the working group of Prof. Marc Stadler, deputy coordinator of the DZIF research area Novel Antibiotics, and accompanied during the technology transfer. The orally administered formulations were developed in Bonn under the direction of DZIF scientist Prof. Karl Wagner (with support from ForTra gGmbH for Research Transfer of the Else Kröner Fresenius Foundation). The formulations will now be used in upcoming clinical trials.
Source: Press release of Phyton Biotech
Information about the involved institutions/companies
- About Phyton Biotech
Phyton Biotech is a global leader in specialty fermentation, renowned for its expertise in Plant Cell Fermentation (PCF®), which derives important phytochemicals used in pharmaceuticals, cosmetics, and food industries at commercial scale. This technology serves an important role in securing at-risk supply chains, and in the preservation of our planet’s endangered plants. With over 200 m³ of installed capacity and certified GMP facilities in Germany and Canada, Phyton provides comprehensive services to support the development and commercialization of natural molecules by fermentation. Phyton Biotech has a proven track record of delivering innovative solutions for clients worldwide and is the world’s largest producer of Paclitaxel and Docetaxel via PCF®.
For more information, please visit phytonbiotech.com.
- About University Hospital Bonn (UKB)
For more information on the Institute for Medical Microbiology, Immunology and Parasitology at the University Hospital Bonn, please visit https://www.microbiology-bonn.de/en
- About Helmholtz Centre for Infection Research (HZI)
Scientists at the Helmholtz Centre for Infection Research (HZI) in Braunschweig and other partner sites in Germany investigate bacterial and viral infections and the body's defense mechanisms. They have in-depth expertise in natural product research and its use as a valuable source for novel anti-infectives. As a member of the Helmholtz Association and the German Center for Infection Research (DZIF), the HZI conducts translational research to lay the foundations for the development of novel therapies and vaccines against infectious diseases.
Further information is available at:
https://www.helmholtz-hzi.de/en/media-center/newsroom/news-detail/new-antibiotic-against-river-blindness-and-lymphatic-filariasis-pathogens/
https://www.helmholtz-hzi.de/en/research/research-groups/details/microbial-drugs/
https://www.helmholtz-hips.de/en/research/teams/team/microbial-natural-products/- About the German Center for Infection Research (DZIF)
At the German Center for Infection Research (DZIF), more than 700 researchers from 35 institutions across Germany are working together to develop new approaches to the prevention, diagnosis, and treatment of infectious diseases. The goal is translation: the rapid, effective implementation of research results in clinical practice. In this way, the DZIF is paving the way for the development of new vaccines, diagnostics, and drugs against infections. The DZIF is one of eight centers in the German Centers of Health Research (DZG) network.
For more information about the DZIF, visit www.dzif.de.
For more information about the DZG, visit deutschezentren.de/en/.
- About Global Health Innovative Technology (GHIT) Fund
The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Gates Foundation, Wellcome, and the United Nations Development Program (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world’s vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics.
https://www.ghitfund.org/