Noubar Afeyan, Flagship CEO (Victor Boyko/Getty Images for Aurora Humanitarian Initiative)

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. 

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

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As­traZeneca tri­al shows mod­est ben­e­fit in ovar­i­an can­cer, but doc­tors say it's hard to ap­ply find­ings: #AS­CO23

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

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