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NunaBio Sees Opportunities in Diagnostics, NGS for Primerless Enzymatic DNA Synthesis Tech


NEW YORK – NunaBio, a spinout of Newcastle University in the UK, is moving ahead with plans to commercialize a new enzymatic DNA synthesis technology for use in numerous applications, including diagnostics. The Newcastle-on-Tyne-based firm was recently awarded a trio of grants in the UK to further develop its technology and raised £2 million ($2.5 million) in a seed round.

"DNA has become a component of a wide variety of materials, but the production of it, the purchasing of it, is not plug and play," said CEO Joe Hedley, who has led NunaBio since its founding two years ago. "It's not that you press a button and you get your DNA."

For DNA to become a "mainstream material," its production needs to become automated, and the new awards and funding will allow NunaBio to do so.

Hedley took the helm of NunaBio in April 2021 after holding business development roles at Newcastle University and Northumbria University. From 2012 to 2016, he headed up the chemistry team of QuantuMDx, a molecular diagnostics firm that is also based in Newcastle and has brought a point-of-care, multiplex PCR testing platform called Q-POC to market.

Hedley said NunaBio plans to sell probe sets for diagnostic applications that could provide the same enhancements in signal that nanotechnologies or fluorescence-based platforms offer. While the proof is in the pudding, if NunaBio could amplify a signal by 25-fold, it could make a difference in diagnostics. He noted that NunaBio would enter the diagnostics market through partnerships. "We are not in device development," he said. "We make DNA."

The company's DNA could also be employed in multiplex technologies, such as microarrays. In addition, NunaBio could make sequence capture probes for next-generation sequencing applications, Hedley added, such as small diagnostic panels with hybrid capture probes capable of capturing more than current biotin-labeled probes. Since NunaBio can churn out repeat sequence DNA easily, it could also provide DNA for calibrating sequencing instruments, he pointed out.

End users producing diagnostics or gene therapies could in-source NunaBio-produced DNA into existing pipelines, Hedley said. On its website, NunaBio says it can produce short oligos, repetitive sequences, homologous DNA fragments, longer genes, gene fragments, and homopolymers.

NunaBio has been developing an enzymatic DNA synthesis technology, an approach also pursued by other firms such as DNA Script, Molecular Assemblies, Ansa Biotechnologies, Twist Bioscience, and Evonetix.

Eimer Tuite, the firm's CSO and a senior lecturer in biophysical chemistry, and Chief Technology Officer Andrew Pike, director of expertise in chemistry at Newcastle, have described methods for the enzymatic synthesis of DNA in a 2018 publication. Another 2015 paper co-authored by Tuite and Pike described a PCR-based method for preparing long DNA that relied on the use of two seeding oligodeoxynucleotides, called oligoseeds, that were extended using a thermostable archaeal DNA polymerase. Following multiple rounds of heat-cool extension cycles, the oligoseeds were elongated, and 20 such cycles produced long DNA with repeating sequences to over 20 kilobases in length, according to the paper.

Hedley described the firm's technology as relying on "primerless PCR" but declined to provide further details.

Natasha Arkley, a field application specialist at NunaBio, said that each of the competing companies has its own, distinct approach. "When you actually look at all their technologies in depth, they are all quite different and different to us," she said.

She noted that both Molecular Assemblies and Ansa use a version of terminal deoxynucleotidyl transferase, or TdT, for nucleotide incorporation during DNA synthesis. While NunaBio does use the same approach at the beginning of its synthesis process, the rest of the firm's method is different, she said.

NunaBio raised £2 million in April, with participation from the North East Innovation Fund, an EU-supported investment fund managed by Newcastle-based Northstar Ventures. The London-based Pioneer Group also participated in the round, as did fellow UK investors Ascension Life Fund and Martlet Capital.

The proceeds of the round allowed the company to move into Newcastle Helix, a 24-acre site built for tech companies in the city, as well as to hire about 10 staffers, bringing its headcount to 17, while working to acquire the equipment needed to move its technology "from piecemeal production into a proper commercial footing," Hedley said.

The company already has initial customers that it brought on board through preexisting industry contacts. "Synthetic biology has been a huge space, and enzymatic synthesis of DNA is a key area for major businesses," he said. "So it was relatively easy for us to form a busy pipeline."

The company has also racked up three grants to support its technology development.

It recently won a £519,000 Biomedical Catalyst 2022 Round 2 award from Innovate UK, the government's innovation agency, for a project called "automated surface-bound oligoseed DNA amplification enabling advanced therapies and diagnostics." The project commenced April 1 and will run through 2025.

NunaBio also just received a £457,000 Innovate UK Engineering Biology Collaborative Research and Development Round 1 award for a project entitled "Scalable economic DNA synthesis by oligoseed amplification with novel DNA polymerase enzymes." The project is set to commence in September and will run for 18 months.

In March 2021, NunaBio received another award from Innovate UK called "Providing DNA solutions." As part of that project, it partnered with Palintest, a Gateshead, UK-based firm, to demonstrate the utility of its DNA in a water testing platform. The effort had a budget of £209,486 and wrapped up in September 2022. Hedley said the project was "really useful" for the company and showcased that its technology could be applied in other contexts for DNA detection.

Potential rivals include Ansa Biotechnologies, which also has an enzymatic DNA synthesis platform. Last month, the Emeryville, California-based company announced that it had begun shipping DNA to its first customers via an early-access program. Ansa also closed a Series A round worth $68 million last year. 

Molecular Assemblies, a San Diego firm, also began shipping DNA produced using enzymatic DNA synthesis technology earlier this year. The company raised $26 million in a Series B round last year. Investments have also poured in for Evonetix, a Cambridge, UK-based firm developing a microfluidic DNA synthesis platform, which raised $24 million as part of its Series B in February. 

DNA Script is also serving the same market with Syntax, an on-site, on-demand enzymatic DNA synthesis platform. The company, which is based near Paris, began offering its products via an early-access program last year and unveiled a fully automated benchtop system, called the STX-200, last month.