Bayer, Amgen back ReCode’s plan to broaden genetic medicine’s reach

The success of Pfizer’s and Moderna’s COVID-19 vaccines put a spotlight on the messenger RNA they contain that trains the body to defend against coronavirus infection. But while mRNA is the star, neither of the shots would work without the fatty shells that protect them.

Known as lipid nanoparticles, these shells help to package and transport delicate mRNA into the body’s cells.  Getting them to the right cells, though, is an even harder challenge, one that ReCode has raised more than a quarter of a billion dollars to address.

Building on research done by Daniel Siegwart at the University of Texas, ReCode is developing lipid nanoparticle technology it’s dubbed SORT, short for selective organ targeting. The idea is that SORT-based lipid nanoparticles could be directed at specific organs to treat disease, potentially even bypassing the liver, where most infused medicines end up. 

So far, Recode is studying mRNA medicines delivered by SORT nanoparticles to the lungs to treat cystic fibrosis and another rare disorder called primary ciliary dyskinesia. 

On Wednesday, Recode revealed it has raised $120 million to add to an $80 million Series B funding announced late last year. The startup plans to use the cash infusion to further develop its lead candidates as well as expand its research into cancer and diseases affecting the central nervous system and liver. 

The funding comes as biotech startups are struggling to go public amid a sector-wide downturn that’s begun to impact venture financing, too. 

Shehnaaz Suliman, ReCode’s CEO, acknowledged the difficult financing environment but pointed to the company’s latest cash infusion as an example of how new technology can still gain the support of investors. 

“I think this funding is great validation of the fact that it underscores the importance of following the science,” said Suliman. “If the science is compelling, the opportunity will be there.”

ReCode is backed by a number of large pharmaceutical companies, as well as traditional venture capital firms. The Series B round was co-led by Leaps by Bayer and AyurMaya and included participation from Amgen. Initial investors in the Series B include EcoR1 Capital and the venture arms of Sanofi and Pfizer.

ReCode previously raised an $80 million Series A round in March 2020, before the biotech sector began to slow down. 

The startup initially chose diseases that were a good match for its approach with mRNA delivered by lipid nanoparticles. 

While Vertex has turned cystic fibrosis into a treatable disease with its four approved medicines, approximately 10% of patients don’t benefit and need treatment options. 

Other biotechs have tried to develop treatments for cystic fibrosis, but have been unsuccessful. Their approach to treatment differs from ReCode’s, however. 

Primary ciliary dyskinesia, or PCD, has no available treatments.

With the Series B, ReCode now plans to move towards testing its technology in patients. The company expects to ask for Food and Drug Administration permission to begin clinical trials in cystic fibrosis and PCD later this year or in early to mid-2023. 

In May, ReCode presented preclinical data from its cystic fibrosis and PCD programs at the American Thoracic Society 2022 International Conference. The company claimed its data showed its technology can deliver mRNA to the correct cells and express the desired proteins. 

Chief Scientific Officer David Lockhart said the model to deliver mRNA into cells was already established, so ReCode’s goal was to show that it platform was “delivering not just into the lungs, generally, but to the right cell types.”

“We show all of the key parts that are necessary for a therapy of this type to actually work,” Lockhart said. 

The additional funding suggests others see promise in ReCode’s technology, too. Suliman expects the company to sign research partnerships in the future and, if financing difficulties persist, to remain open to other options.

Rakhshita Dhar from Leaps by Bayer and Alan Colowick from Matrix Capital Management will join ReCode’s board of directors in conjunction with the Series B raise.

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