It’s no secret that fast and accurate DNA manufacturing is a bottleneck for the next-gen therapeutics industry—which is why we were excited to see pharma giant GSK partner with cell-free DNA company Elegen. The collaboration between the companies will focus on therapeutics and vaccines, particularly RNA vaccines. I spoke with Elegen founder and CEO Matthew Hill to better understand how pharma works with synbio companies and how the nucleic acid therapeutics space has evolved post-COVID.

To set the scene, here’s the collaboration in a nutshell: GSK will be able to leverage and license Elegen’s ENFINIA DNA in a multi-year deal for a near-term value of $35 million in fees and purchasing commitments as well as development support and potential milestone payments. The pharma giant also has the opportunity to make an equity investment in Elegen down the road. 

“So, what does all this mean in the coming months and years?” I ask Hill.

“The rapid expansion of DNA and RNA-based therapies is truly exciting,” says Hill. “I think the whole world is watching to see which new modalities succeed in development and the clinic.” Hill points to Moderna’s phase 2b readout from its individualized neoantigen/ pembrolizumab monotherapy combo trial for melanoma. “If this succeeds, it will be a huge step forward in treating cancer, and I think it will open the floodgates to additional personalized modalities.”

Of course, there are a lot of hurdles between that promising future and now. Unsurprisingly, Hill is focused on eliminating the DNA production bottleneck. Currently, scientists spend weeks to months manipulating DNA, significantly impeding innovation across all sectors, not just in biopharma. “Scientists should spend exactly zero time thinking about how DNA is made,” insists Hill. “They should be able to focus on designing experiments and interpreting data to gain insights.” 

For Elegen, the company achieves this by rapidly producing cell-free linear DNA (up to 7kb in seven business days). This method enables a much easier transition into GMP manufacturing when compared to linearized plasmid DNA and saves significant time in iterative cloning and purification. The hard work of transforming how the scientific community gets DNA is finally paying off, and some of the drug industry’s biggest customers are taking note. Enter Big Pharma.

Big Pharma has been looking to improve the targeting, delivery, and efficacy of novel drugs and modalities for a while now. “Of course, in many cases, Big Pharma is letting smaller companies bear the risk of new modalities, but they are watching carefully,” explains Hill. It’s a frustrating paradigm, but manufacturing DNA and RNA remains a crucial hurdle in the pharma supply chain regardless of modality. For Hill, this creates a perfect opening for Big Pharma to embrace synbio technology. “This is precisely what led to the recent agreement between Elegen and GSK. Elegen’s cell-free DNA production technology offers the potential for Big Pharma to streamline genetic medicine development from discovery to the clinic,” Hill says.

The GSK partnership isn’t the only thing on Elegen’s plate in the coming months. The team is expanding its rapid production capacity for long, complex DNA and significantly improving its manufacturing process. For select partners, Elegen is already delivering highly accurate DNA with well-defined poly-A tails to serve as “IVT-ready” DNA templates for mRNA synthesis. The company plans to officially launch this product commercially later this year. As the DNA roadblocks fall away, we’ll be watching closely to see how the growing field of nucleic acid therapeutics evolves and how quickly these innovations can reach patients. 

You can meet Elegen and many more innovators at SynBioBeta 2024!