bit.bio pursues global billions after winning key patent battle

Following an anonymous opposition filed on 5 January 2023, the European Patent Office (EPO) upheld bit.bio's European Patent (EP3545079), securing the broadest possible claims and protections in the field of transcription factor mediated forward programming of PSCs.

Following a public hearing on 25 September 2024, the EPO’s Opposition Division confirmed the patent's validity after a rigorous scientific and legal review, maintaining its broad claims and affirming its novelty and inventive step.

The EPO ruling reinforces bit.bio's position as the global market leader in scalable and consistent iPSC-derived cell manufacturing and demonstrates the strength of its intellectual property portfolio.

This decision builds on three key patents granted in 2023 across major markets, including United States Patent 11697823, Chinese Patent CN110249045 and South Korean Patent KR102500322.

With patents now secured in four major markets and applications pending in countries including Australia and Japan, bit.bio is strategically positioned to lead the next wave of innovation in iPSC-derived cells for R & D applications and cell-based therapies.

Mark Kotter, CEO of bit.bio, said: “This successful defence of our European patent is a significant milestone for bit.bio. Our unique ability to conduct multiplexed screens of over 2,300 transcription factors, combined with our AI platforms that rapidly predict and read out transcription factor combinations that define cell types, is driving the expansion of our cell type portfolio and IP.

“Our team’s dedication and expertise were instrumental in firmly establishing bit.bio as the global leader in cell programming technology.”

bit.bio’s opti-ox technology enables a paradigm shift in the manufacture of human cells from pluripotent stem cells, establishing iPSC-derived cell therapies as an emerging modality in medicine, much like the transformative impact CRISPR had on genome editing.

Using a dual genomic safe harbour (GSH) approach, opti-ox deterministically controls gene expression, allowing for the rapid and consistent conversion of induced pluripotent stem cells (iPSCs) into specific human cell types at an industrial scale.

The achieved consistency and scalability is unprecedented and is critical to industrialise human cells for both research and therapeutic applications in a cost-effective manner.

bit.bio's opti-ox technology is already playing a crucial role in providing off-the-shelf human cell models at scale for a variety of diseases, including Alzheimer's and Parkinson's. The company's ioCells™ for research and drug discovery are recognised for their functionality, consistency, and scalability.

According to stem cell research firm BioInformant, the global market for iPSC-derived biomedical research tools is currently valued at approximately $1.3 billion, though it remains in its early stages, limited by product breadth and quality.

bit.bio projects the addressable market for its ioCells to exceed $10 billion, considering significant opportunities in the $3 billion primary cells market (Precision Business Insights, Zion Market Research), the $25 billion high throughput screening market (Global Market Insights, Grand View Research, Markets and Markets), and the $25 billion in vitro toxicology market (Allied Market Research, Global Market Insights, Grand View Research, Markets and Markets, Precedence Research).

Dr Hermann Hauser, Chairman of the Board of bit.bio and co-founder of Arm and Amadeus Capital Partners, said: “Being at the forefront of cell programming with IP that protects indispensable technology gives bit.bio an opportunity to create a truly transformative business.

“The current market size for R & D grade cells is valued in the billions but our opportunity reaches far beyond that. Given the transformational potential of cell therapies, the market for iPSC-derived therapeutics is likely to exceed that of biologics. This opens up unprecedented opportunities for growth and innovation in personalised medicine and drug discovery."

Since spinning out from the University of Cambridge and launching in 2016, bit.bio has raised around $200m from leading investors, including Arch Venture, Blueyard Capital, Charles River Laboratories, Foresite Capital, Milky Way, National Resilience, and Tencent.

The company won the coveted Life Science Innovation prize, sponsored by AstraZeneca, at the recent Business Weekly Awards.