Nouscom Reaches Clinical Phase II Using ProBioGen’s AGE1.CR.pIX® Production Platform
Berlin, Germany – May 4, 2023
ProBioGen announces that their proprietary vaccine production cell line AGE1.CR.pIX® has been successfully used to manufacture a viral vector product that has advanced into a randomized phase II clinical trial. Nouscom has in-licensed ProBioGen's platform technology for the GMP production of a component of their neoantigen targeting cancer vaccine, Nous-209 targeting Microsatellite Instable High (MSI-H) solid tumors.
Nous-209 has been developed using the Nouscom's viral vector platform, which includes adenoviral and Modified Vaccinia Ankara (MVA) vectors, with MVA vectors manufactured using ProBioGen's AGE1.CR.pIX. This is Nouscom's third and most advanced clinical candidate benefitting from ProBioGen's production cell platform. The milestone represents a significant step towards bringing new, innovative products to patients and further underscores ProBioGen's commitment to supporting the development of life-changing treatments. Significant undisclosed milestone payments have been received by ProBioGen.
Dr. Richard Davis, Chief Operating Officer at Nouscom said: "Based on compelling early clinical and translational data, we are delighted with the progression of NOUS-209 into randomized global phase 2 clinical trials. ProBioGen's AGE1.CR.pIX cell line has allowed us to develop a reproduceable and scalable process for MVA manufacture, and we look forward to furthering our close relationship as we continue to progress our pipeline through clinical trials."
"We commend Nouscom for achieving this important milestone with this prime-boost vaccine approach addressing a clear unmet need.", stated ProBioGen's Chief Scientific Officer, Dr. Volker Sandig. "In this case it is also a testament to our AGE1.CR.pIX production technology as a most advanced solution to manufacture a potent viral vector."
The AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and was designed to comply with health authority guidelines and the concept of "defined risk". It was developed as an alternative to the use of chicken eggs for large-scale vaccine production. The AGE1.CR.pIX cell line grows in true suspension and has been optimized for viral vaccine production and stability. It grows in a commercially available, chemically defined medium without animal components and is an excellent host for a variety of different virus strains.
ProBioGen is a Berlin-based specialist for developing and manufacturing biopharmaceutical active ingredients, viral vectors and vaccines with applying proprietary technologies to improve product quality and features.
Combining both state-of-the-art development services, based on ProBioGen's CHO.RiGHT® expression and manufacturing platform, together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).
ProBioGen has been operational for more than 25 years. At three locations in Berlin, over 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen's growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisition. Diversification is a complement driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.
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Dr. Gabriele Schneider
Chief Business Officer