Flagship startup Omega takes lead 'epigenomic controller' candidate closer to the clinic with new $126M round
In its quest to drug the undruggable, Flagship Pioneering startup Omega Therapeutics is chasing a moonshot with “epigenomic controllers” to get all of the benefits of gene editing without the actual editing. That’s a tall task to craft a new class of therapeutics, but investors are certainly showing interest.
Omega plans to advance its lead candidate for the c-myc oncogene into human testing and establish a manufacturing footprint with proceeds from a $126 million Series C the biotech closed Tuesday.
Omega, which launched in 2019, is using its drug discovery platform to target what it calls insulated genomic domains (IGDs), paired DNA sites with a protein binder that up- or downregulate gene expression in localized “zip codes,” Omega said. By targeting epigenomics, Omega believes it can modulate gene expression in a hypertargeted way without having to add or delete nucleotides in patients’ genetic code.
It’s an ambitious plan but one that keeps earning investors’ interest for its promise at a novel class of therapeutics as well as another shot on goal at “undruggable” targets. So far, Omega has raked in $210 million in fundraising with Flagship leading the way on the newest round. It’s joined by Invus, Fidelity Management & Research Company, and funds and accounts managed by BlackRock, Cowen, Point72, Logos Capital, Mirae Asset Capital and others.
Omega’s immediate next step is taking lead candidate OTX-2002, what it calls an “Omega controller,” into a Phase I proof-of-concept study against c-myc, a “master” oncogene that crops up in a high percentage of tumor types. The drug is in IND-enabling studies, and Omega isn’t yet ready to say when that filing will come, Flagship CEO and Omega co-founder Noubar Afeyan told Endpoints News. One of the other aims of the round is to advance and eventually unveil even more candidates for trial, and Afeyan said OTX-2002 would likely be filed when at least one other candidate is also on the road to the clinic.
Meanwhile, Omega is planning to use some of the round’s proceeds to establish a manufacturing footprint that Afeyan called “quite modest” in scope despite the potential for multiple candidates in the coming year. Unlike gene therapy or gene editing which require the cultivation of live viruses or complex biologics, Omega’s controllers utilize mRNA and lipid nanoparticle technology that Flagship companies — including Moderna — have pioneered elsewhere, Afeyan said. That depth of experience and the “programmable” nature of Omega’s drugs means the biotech can plug and play with its manufacturing approach and scale to commercial demand with relative ease.
“Given the potency of that approach, the actual volumes you need for disease like cancer or liver diseases is relatively modest,” Afeyan said. “So what the company needs in the next two to three years is quite modest, but it’s really important that we own and control it because in these kinds of companies, a big part of the success depends on the predictability of supply of clinical materials. That’s a big part of our value proposition.”
Editor’s Note: This story was updated to correct an error. Omega closed a $126 million Series C.