Company: Forge Genetics
Location: Nottingham, England
Founded: 2023
Written by: Ariyana Rayatt
Edited by: Natasha Barrow & Caroline Babisz
Genetic engineering is a fast-paced field and biotech Forge Genetics, offers a unique technology called Forge Editing, to catapult the industry further. We have covered Forge Genetics in a previous Start-up Spotlight, where you can read a more in-depth summary of their background. But here we will discuss Forge Genetics' vision for the future and how they look to tackle their upcoming challenges.
The start-up is very much still in its early days and is currently using its Forge Editing technology solely in bacterial cells. With their eyes on the gene therapy market, the next step is to prove that the technology works safely in mammalian cells. This work is expected to be fuelled by future investments as they aim for £2 million in their next funding round. Optimism within the team is contagious, the team expects that proof of successfully editing mammalian cells with Forge Editing will be achieved by 2025. After reaching this goal post, the next step is collecting safety data. Following guidance from both the Food and Drug Administration (FDA) and European Medicines Authority (EMA) surrounding gene editing and gene therapies, Forge aims to collect data on the genomic integrity, immunogenicity and clonal expansion capabilities of Forge Edited cells by 2027. Armed with this knowledge, Forge Genetics hopes to establish Forge Editing as a simpler and safer option for cell and gene therapies, compared to other gene editing technologies on the market.
Unlike many biotechnology start-ups, in less than two years, Forge Genetics is already generating income. How? They have leveraged their technology's success in bacteria to offer clients strain development services. Leading pharmaceutical and industrial players have partnered with Forge in deals worth in excess of £1.3 million in their first year of trading. This strategic move will enable the biotechnology company to build a portfolio of real-world applications as well as create the option for Forge to invest in themselves - a rare position for the start-up world. Beyond acting as a contract research organisation (CRO), the longer-term vision is to move towards a more typical licensing model of Forge Editing. The pricing model would reflect the development of the technology through the regulatory stages; for instance, those who obtain licences for preclinical stages would receive a lower rate than licences distributed after clinical approval.
Genetic editing is not a new concept and with CRISPR already having made waves in the field, Forge Genetics aims to benefit from its second-mover advantage. The primary advantages are that the regulatory field has already been navigated and it is clear that the potential of the gene therapy market is still yet to be realised, with the only one CRISPR-approved drug on the market. In the case of gene therapies, Forge Genetics is exploring the regulatory grounds for existing therapeutics to make a switch from CRISPR to Forge Editing, and whether this would affect approvals. If not, does this offer a feasible door for potential clients? Dr Craig Woods, (CEO, Forge Genetics) explained that Forge Editing has a unique ability to screen edited cells which results in safer gene-edited therapies. Supporting Forge Genetics through this regulatory minefield, is their advisor, Dr Sophie Dale-Black. Woods described Dale-Black, as a "source of wisdom on many fronts", which they hope will guide them with her broad experience across investments, communications and science. With the focus on expansion, they are considering bringing more regulatory and gene therapy expertise onto the team as they look to the most efficient way to reach their 2027 goal.
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