Adrian Gottschalk, Foghorn CEO

Mer­ck dan­gles up to $425 mil­lion to team with Flag­ship’s Foghorn Ther­a­peu­tics on drug­ging the shape of DNA

Two years af­ter it first emerged from stealth mode, Flag­ship’s Foghorn Ther­a­peu­tics has nabbed its first Big Phar­ma part­ner as Mer­ck signs on to the biotech’s vi­sion of drug­ging the very shape of DNA.

The deal, worth up to $425 mil­lion but with the up­front cash undis­closed, comes as Foghorn nears a piv­ot to a clin­i­cal stage biotech. The Cam­bridge-based com­pa­ny has added near­ly 60 staffers from the 25 it had when it first emerged out of Flag­ship and, CEO Adri­an Gottschalk said, they have fi­nal­ly re­fined the screen­ing tech­nol­o­gy at the heart of the com­pa­ny, with plans to file their first IND to­wards the end of the year.

“In the last 6 months, ac­tu­al­ly pri­or to the con­ver­sa­tions with Mer­ck, we had in­dus­tri­al­ized our abil­i­ty to in­ter­ro­gate the bi­ol­o­gy,” Gottschalk told End­points News. “We’ve made some very nice progress, re­al­ly start­ing from scratch sev­er­al years ago.”

First found­ed in 2016, Foghorn is one of a spate of re­cent biotechs that try to treat can­cer by tar­get­ing how genes are ex­pressed, as op­posed to try­ing to change the genes them­selves or in­hib­it the pro­teins they code for. Michael Gilman’s Ar­rakis Ther­a­peu­tics is built, like Foghorn, on drug­ging DNA reg­u­la­tors called tran­scrip­tion fac­tors and ear­li­er this year got $190 mil­lion up­front and “sev­er­al bil­lion” in mile­stones for a deal with Roche. Sy­ros, an­oth­er Flag­ship-backed com­pa­ny, at­tract­ed con­sid­er­able buzz sev­er­al years ago by go­ing af­ter so-called “su­per-en­hancers,” though they have since strug­gled to find trac­tion in the clin­ic. More broad­ly, the still-ju­ve­nile field has yield­ed few ma­jor in-hu­man suc­cess­es.

Mer­ck has al­ready sig­naled its be­lief in the ap­proach, at least in cer­tain man­i­fes­ta­tions. Last year, they bought up Pelo­ton Ther­aepeu­tics and its late-stage, kid­ney can­cer tran­scrip­tion fac­tor drug for $1 bil­lion in cash and an­oth­er $1 bil­lion in mile­stones.

Foghorn’s twist, Gottschalk said, is look­ing at how these fac­tors in­ter­act with these spher­i­cal struc­tures on top of DNA, called chro­matin re­mod­el­ing com­plex­es. Ba­si­cal­ly, hu­man DNA con­tains bil­lions of genes, not all of which are turned on at any point in time or in any cell. That DNA sits in tight­ly com­pact­ed strands called chro­matin at the nu­cle­us at the cen­ter of the cell, and one of the ways the body can de­cide which genes need to be turned on is to open and close those strands.

The mol­e­c­u­lar thing that de­ter­mines whether and where genes are turned on is the in­ter­ac­tion be­tween those tran­scrip­tion fac­tors that car­ry in­struc­tions and the chro­matin re­mod­el­ing com­plex that does the open­ing and clos­ing. Foghorn com­pares it to air traf­fic con­trol, the two types of pro­teins telling the genes where to launch and where not to launch. And Gottschalk cit­ed da­ta that sug­gest around 25% of can­cers can be chalked up in part to those bi­o­log­i­cal con­trollers get­ting their sig­nals crossed.

For the last four years, Foghorn has de­vel­oped a high-through­put screen­ing sys­tem to al­low their sci­en­tists to mod­el both the tran­scrip­tion fac­tors and the re­mod­el­ing com­plex­es and fig­ure out which mol­e­cules can mod­u­late each. Though “high-through­put screen­ing” is about as com­mon a word in the drug in­dus­try these days as “pan­cakes” are in the din­er in­dus­try, Gottschalk said that was no easy feat. The chro­matin re­mod­el­ing com­plex­es are just that — com­plex — and they need­ed to set up a sys­tem that could han­dle pro­teins as much as ten times as large as the ones most screens han­dle.

Un­der the new deal, Mer­ck has es­sen­tial­ly li­censed one of the fac­tors Foghorn has just be­gun test­ing, buy­ing ex­clu­siv­i­ty on any po­ten­tial drugs that emerge to tar­get it. In­ter­nal­ly, mean­while, Gottschalk said that af­ter years build­ing their sys­tems, the com­pa­ny is prepar­ing to soon bring a few of its 10 pre­clin­i­cal and un­named pro­grams in­to the clin­ic for sev­er­al ge­net­i­cal­ly-de­fined can­cers that cur­rent­ly have few good treat­ment op­tions.

“I think this bi­ol­o­gy has been un­ex­plored and un­ex­ploit­ed as drug, and I think the time is right,” Gottschalk said.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Atomwise CEO and co-founder Abraham Heifets (left) and co-founder Izhar Wallach

A cou­ple bil­lion for Ex­sci­en­tia was on­ly part of Sanofi's AI am­bi­tions, as the Big Phar­ma adds Atom­wise to the ta­ble

Sanofi made clear its AI ambitions were real at the beginning of this year when the Big Pharma took its drug discovery collaboration with Exscientia to the next level, inking a pact that could birth 15 drugs and deliver $5.3 billion to the UK partner.

Seven months later, the AI blueprint is far from over at the French Big Pharma, as another of the much-hyped drug discovery startups is coming to the table in a five-drug deal. Sanofi will pay Atomwise $20 million to kick off the hunt for up to five targets, which are aimed at leading to the creation of new small molecules. Another $1 billion is on the line — as are royalties — and the companies kept mum on the specific diseases or broader therapeutic areas of interest.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.