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$60M Wellcome Leap R3 Program to Support Network of RNA-Based Biofoundries

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A previous version of this story reported the budget of R3 as €60 million, not $60 million. The amount has been corrected.

NEW YORK – A new program backed by Wellcome Leap, the US nonprofit founded last year by the UK's Wellcome Trust, will lay the foundation for a series of new, RNA-based biofoundries to support access to diverse biologics, including mRNA vaccines and monoclonal antibodies.

The effort, called RNA Readiness + Response, or R3, commenced last month with a budget of $60 million, partially funded by the Coalition for Epidemic Preparedness Innovations, a Davos, Switzerland-based partnership focused on vaccine development. The program is expected to aid increased investments in RNA-based products, which the organizers maintain are currently limited by manufacturing constraints.

According to Duccio Medini, R3's program director who previously worked in vaccine research and development at GlaxoSmithKline and Novartis, every new RNA product currently requires developing a new process.

"There is no standardized platform" for manufacturing RNA products, he said. "If you want to do a certain vaccine, you have to reinvent the process. Then if you want to do another vaccine, you have to redo the process, get it reapproved by regulators, spend more to stand up a manufacturing line, and do the tech transfers."

According to Medini, R3 is not directly applicable to genomics, but rather will serve to help realize discoveries made by genomic researchers and translate those into products. One example is RNA vaccine development, spurred by the global uptake of Moderna and Pfizer's mRNA-based vaccines during the ongoing COVID-19 pandemic.

Wellcome Leap anticipates there will be a wave of activity to discover, develop, and deliver new RNA-based biologics, Medini said, and that various organizations from academics to biotechs to research centers will soon need reliable, scalable biofoundries to manufacture them so they can be tested against existing and emerging diseases.

According to Medini, R3 has three strategic elements. One is to build a global platform to produce RNA-based biological products. A second is using digital data science to make the design and development of new RNA-based products accessible to all developers via a simulation platform. This would allow anyone from academic researchers to scientists at pharmaceutical companies to design such products, he said. A third aim is to establish clinical-grade manufacturing capacity to allow products designed on the simulation platform to be immediately manufactured.

While these aims would suggest either establishing a commercial entity to handle manufacturing or partnering with an existing foundry, Medini said that R3's aims are independent of what organization or company does the manufacturing. "The foundries could be owned by contract manufacturing organizations or by vertically integrated companies or newer entities that take a pure-play business model," he said. "The important thing is that there is a standardized process."

R3 is expected to run for three years. By the end of the program, Wellcome Leap hopes to have a physical foundry in place that can manufacture multiple products on the same standardized platform. The technology should also be capable of being replicated elsewhere using the same processes. "We want these capabilities to be easily deployable to where the products are needed," Medini said.

The application areas are not limited to human health. RNA-based pesticides have been developed and approved by the US Environmental Protection Agency in recent years, for instance. "RNA is such a versatile molecule that we envision a broad usage of the same underlying manufacturing technology in a diverse slate of products," he said.

Medini did not say what specific technology would be used to achieve the aims of R3 but mentioned self-amplifying RNA as a promising technique.

Multiple companies exist to meet the needs for synthetic biology, such as Ginkgo Bioworks and Twist Bioscience. Boston-based Ginkgo, for example, has acknowledged that it has provided materials for Moderna's mRNA-1273 vaccine.

Wellcome Leap is currently headquartered in Los Angeles but includes principals around the world, such as Medini, who is based in Italy. It maintains an independent board chaired by Jay Flatley, the former CEO of Illumina and current acting CEO of Zymergen.

Ken Gabriel, Wellcome Leap's chief operating officer, is based in Cambridge, Massachusetts. He noted that Wellcome Leap is operating according to a unique funding model. Rather than putting out a call for proposals and then accepting the best ones for financing, the organization is liaising with various parties to achieve its own aim of delivering technology breakthroughs.

"We don't select performers, or ask for great ideas and evaluate them against each other and rank them," said Gabriel, who previously was CEO of the Draper Laboratory in Cambridge, a nonprofit research organization focused on technology development. "We rank and evaluate proposals against the objective of the program," he added. "The program director selects the proposals that are best suited to achieve those objectives."

In addition to R3, Wellcome Leap is also funding research programs focused on depression, tissue state, human organs, and children's cognitive health. While the programs are run independently of each other, they all sit at the intersection of life sciences, engineering, and the physical sciences.

"We don't fund exclusively life sciences activities or engineering activities or physical sciences," noted Gabriel. "We see that intersection space as rich with opportunities for breakthroughs. That is fundamentally the key difference in this model. We invest to make breakthroughs in capabilities."

Gabriel likened the ambitions of R3 to developments in the semiconductor industry. "In the 1950s and 1960s, semiconductors and electronics were precious things that you only used for important projects like the space program," he said. "Now that it is no longer a precious technology, you can open up the technology and it creates a virtuous cycle of new products that generate demand for new facilities."

With RNA, though, Gabriel cautioned that the goal should not be to just set up a big foundry that collects dust while the world waits for the next pandemic, but rather to have a well-greased machine in place, so when that capacity is needed, the supply is already there. "When the next pandemic comes along, you will have an existing manufacturing base that you can move to make what you need and then return it to standard production," he said.

Gabriel said some but not all of the components to meet the goals of R3 are in place yet. "We think that some of the pieces exist, but six months from now, we will find out something doesn't exist," he said. "Then we will need to work on it and make it happen."

Like Medini, Gabriel also could not comment on what specific technologies will be used in R3, but he said the effort is not necessarily wedded to any approach. "We may make multiple shots on goal and try different approaches," he said. "Our guiding principle is what will help us achieve the objectives of the program."

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