Touchlight To Disrupt DNA Market With Synthetic Manufacturing

Touchlight has secured £42m ($60m) in funding to support efforts to triple its manufacturing capacity of synthetic DNA based on the company’s proprietary dbDNA platform – an enzyme made minimal linear DNA vector. The completed facility will have the capacity to produce 1kg of GMP DNA per month, enough for one billion COVID-19 vaccine doses.

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The Hampton, UK-based company has followed an unusual funding model to date. The latest financing of £42m was led by Bridford Investments and focused on “a network of ultra-high net worth individuals, family offices and specialist health care investors.”

Karen Fallen, CEO of Touchlight DNA Services, explained this was how the biotech had been financed from the beginning, following founder Jonny Ohlson's vision. “It's just been a very successful model for us so far.”

The company’s platform – named ‘doggybone’ DNA (dbDNA) after the shape of their schematic structure – enables faster, more reliable production and scalability than the incumbent plasmid DNA technology.

It was founded in 2008 by executive chair Ohlson, but its primary focus is now acting as a contract development and manufacturing organization through its DNA Services arm, producing dbDNA as a critical starting material for advanced therapy medicinal products (ATMP) production. Alongside this, the company is also working with partners to develop new therapeutics - DNA vaccines and non-viral gene therapies – and has two assets in the pipeline. The first, TGL-100, is targeting head and neck squamous cell carcinoma and other solid tumors in partnership with Cancer Research UK. The second, TGL-210, is targeting COVID-19. The biotech hopes to begin Phase I/II trials for both in Q2 2021.

Synthetic 'Doggybone' DNA

'We believe we have a superior value proposition' – Karen Fallen, CEO, Touchlight DNA Services

Fallen, CEO of the DNA Services division, explained to In Vivo more about the company's dbDNA platform. The technology is synthetically manufactured, allowing for faster production with a significantly reduced manufacturing footprint when compared with plasmid DNA production. The manufacturing process is five days, as opposed to weeks with a biological process, Fallen explained.

Alongside the manufacturing speed, Touchlight also believes its dbDNA is much easier to modify. Fallen notes that the speed with which COVID-19 variants appear and spread shows just how vital it is for DNA production to keep apace. “Because doggybone is so quick, you can modify and make new variants in a much faster setup than you can with plasmid. That's a real positive,” she said.

This also has applications outside of COVID. “If you take it one step further and you think of the flu market … [after] getting the sequence of next year's variants that you want to put into the flu vaccine, speed is of the essence. So, this type of technology from a speed perspective is fantastic,” Fallen added.

The CEO emphasized the smaller footprint of Touchlight’s technology compared with plasmid DNA production. While building a new biologics facility has a lead time of 24 months, Fallen said that with synthetic manufacturing the ”time to actually kit out a new facility is dramatically reduced … within a few months you can kit out a facility and get ready for GMP manufacturing.”

Once this phase of Touchlight’s expansion is complete, the facility will be 7,500 sq ft “a fraction of the space required by conventional bioreactor-based plasmid DNA manufacture,” the company notes. Additionally, the speed of scalability and reduced facility size lower the company’s capital expenditure costs.

The broad genetics market also requires DNA manufacturing to be flexible. “We need to produce from gram quantities, up to the tens of kilograms. We need a very flexible facility, which is what we're building in London,” said Fallen. While some therapies require much larger quantities of DNA, sometimes it might be a case of small quantities but with a vast patient population. “Our new facility has the ability to deal with both ends of the spectrum, we're designing it with that in mind.”

When asked about the quality of the DNA produced using dbDNA compared with plasmid, Fallen pointed to the removal of sequences of bacterial DNA. “Doggybone DNA is the gene of interest, or the gene of sequence, that our customers want and nothing else. With plasmid DNA a lot of the backbone is the residual part of the bacterial sequences which are essential for plasmids to be replicated and amplified in bacterial cells. You retain those. You've got bacterial sequences that aren't necessary, and you don't really want them from a regulatory perspective.”

 

The biotech has had over 40 customers in the past year do head-to-head comparisons between plasmid DNA and dbDNA, which has found the latter to be equivalent or better, such as when using RNA. “We've shown multiple times that doggybone DNA is equivalent, if not better than plasmid DNA,” Fallen emphasized.

Future-Oriented

Touchlight DNA Services is very future-oriented, with an eye on new markets. The last year has again demonstrated the value and demand for RNA-based vaccines, which are already being explored in a range of therapies beyond COVID-19. Fallen also believes that DNA vaccines could be a new market, alongside the growth in cell and gene therapies. Touchlight is positioning itself to scale-up and meet the coming demand for “100s of kilograms of DNA,” Fallen said.

Fallen was also keen to emphasize that Touchlight has the data and the expertise to work with companies on the development of new products. “With the Touchlight team we have a breadth of experience. We could really look at proof-of-concept and validation of these new markets as well. We have the experience and the talent inside the company to be able to do that.”

Touchlight works with companies across the life sciences sector, from biotech to large pharma. The company also spends significant time working with companies at the early stages of their development when they are making decisions around DNA suppliers. It has a range of partnerships, including one with Janssen Pharmaceutica Inc. (a Johnson & Johnson subsidiary) to evaluate the application of dbDNA for the development of multiple genetic therapies in the fields of infectious disease and oncology.