NewBiologix SA has emerged from the shadows as a technology innovation company developing proprietary and breakthrough platforms for the advanced engineering of cell lines used to manufacture gene and cell therapies.
The company’s DNA-based platform is being developed to address key manufacturing challenges associated with the production of recombinant adeno-associated virus (rAAV) vectors used to manufacture advanced therapeutic drug products (ATMPs). NewBiologix’s $50 million Series A is led by Recipharm A/S with additional funding from company co-founders Igor Fisch and Nicolas Mermod.
“As the number of gene and cell therapies in clinics and markets continues to grow, there is a need for better manufacturing solutions for viral vectors,” said NewBiologix co-founder and CEO Igor Fisch, who has more than 20 years of experience in biotech and cell line development. to a new entity.
“Our mission is to help biopharmaceutical companies treat some of the most lethal diseases by providing them with innovative technologies and solutions to increase the production and efficacy of viral vectors, quickly and more cost-effectively.”
NewBiologix focuses on adeno-associated virus vectors
NewBiologix is currently focused on the recombinant adeno-associated virus (rAAV) vector, the delivery vehicle of choice for gene therapy. The company’s technology will be applied to human (HEK-293) and mammalian (CHO) cell lines. These cell lines will be engineered to be adaptable to meet the demand for viral vectors and the need for multiple therapeutic indications to help couples cope with rare, chronic and currently incurable diseases. Cell lines engineered with the innovative NewBiologix platform will enable more stable rAAV production, higher quality and predictable expression levels, fewer empty capsids, and better batch-to-batch production reproducibility.
“Current gene and cell therapy is primarily focused on rare diseases. We believe our approach to generating rAAV vectors will help biopharmaceutical companies advance to emerging therapies that target larger patient populations with chronic conditions,” said NewBiologix co-founder and senior vice president of research and development, Nicolas Mermod, also a long-time biotech veteran. 20 years. with expertise in molecular biotechnology.
“The NewBiologix platform is a quantum leap forward. Our approach will have a significant impact on cost of goods sold (COG), making gene therapy more feasible for rare diseases.”
NewBiologix leverages next-generation sequencing-based genomic characterization (NGS) to develop a proprietary bioinformatics platform designed to enhance the ability of cell lines for ATMP expression and production. By incorporating NGS-based technology throughout the cell line development process, NewBiologix says it can make data-driven decisions about the stability, integrity and biosafety of cell banks while providing strong supporting data for regulatory submissions.
The Swiss-based company Health Valley will begin beta testing of the cell line prototype with key collaborators in 2024 and anticipates making the virus-produced cell line commercially available in 2026.