bit.bio has successfully defended the European patent for its opti-ox cell programming technology.
After a hearing held on 25 September 2024, the European Patent Office (EPO) affirmed bit.bio’s claim against an anonymous opposition filed on 5 January 2023. The company’s proprietary method for pluripotent stem cell (PSC) programming, opti-ox, was deemed a sufficiently novel and inventive step of innovation (EP3545079).
The European patent joins those secured in three other markets, the US (11697823), China (CN110249045), and South Korea (KR102500322), as bit.bio awaits rulings on similar applications in Australia and Japan. “opti-ox has the potential to revolutionise research and cell therapies on a global scale,” says Thomas Südhof, Nobel Laureate, adding that he believes the approach, “is currently the only way to ensure safe, consistent, and scalable forward programming of PSCs”.
The technology uses bit.bio’s dual genomic safe harbour approach to control gene expression and transform induced PSCs into several cell types. According to Mark Kotter, bit.bio CEO, the method relies on the company’s, “unique ability to conduct multiplexed screens of over 2,300 transcription factors, combined with AI platforms that rapidly predict and read out transcription factor combinations that define cell types”.
After forming out of the University of Cambridge in 2016, bit.bio has raised $41.6m and $103m in Series A and Series B financing, respectively. The company claims its approach could prove integral to research, drug discovery, and cell therapies. Its lead candidate, bbHEP01 (txHepatocytes), is currently in preclinical testing to treat acute liver diseases.
bit.bio has also fostered several partnerships to leverage its platform. In August 2023, the company collaborated with BlueRock Therapeutics to research T cell therapies; the jointly-developed txTreg cells are in preclinical study for autoimmune disorders. In April 2024 it partnered with Bi/ond to study Duchenne muscular dystrophy (DMD), and later in March collaborated with the Michael J. Fox Foundation to advance research and drug discovery for Parkinson’s disease.
Hermann Hauser, bit.bio board chairman, expressed the company’s ambition to establish itself in the cell therapy market, with emphasis on the commercial scalability of their technology. As per a March 2024 report from GlobalData, the global cell and gene therapy market is projected to reach $66bn by 2029; $12.2bn of this is estimated to derive from central nervous system disorders such as Alzheimer’s and Parkinson’s disease, indications on which bit.bio is focussed.
GlobalData is the parent company of Pharmaceutical Technology.
