Omid Farokhzad (file photo)

Seer rais­es $55M as pro­teomics ap­proach­es prime time in dis­ease de­tec­tion, drug de­vel­op­ment

Omid Farokhzad was work­ing in his Har­vard nan­otech lab in 2017 when he found some­thing he knew would be­come his next com­pa­ny. Two years and, as of to­day, over $100 mil­lion in fund­ing for lat­er, he still hasn’t re­vealed what it is.

“We’ve seen them re­port­ed, but we don’t re­al­ly know what their tech­nol­o­gy is or what it does.” Stephen Williams, the CMO of So­ma­Log­ic, the most high-pro­file po­ten­tial com­peti­tor to Farokhzad’s com­pa­ny, Seer, told End­points News.

The tech­nol­o­gy was big, though, or at least Farokhzad thought so. Big enough for him to leave much of his work in Boston, where he launched two com­pa­nies, opened his own lab and spent 20 years across Har­vard and MIT, to spend most of his time build­ing Seer in Red­wood City, out­side San Fran­cis­co. What he said was this: They were try­ing to best-of-both-worlds a sci­en­tif­ic idea. They want­ed to take a study of hu­man pro­teins they said was of­ten con­duct­ed with ei­ther slip­shod speed or painstak­ing pre­ci­sion and make it both fast and metic­u­lous.

Now, ex­act­ly a year af­ter its pub­lic launch and just as So­ma­Log­ic eyes its biggest com­mer­cial ex­pan­sion, Seer is an­nounc­ing $55 mil­lion in Se­ries D fund­ing and its own piv­ot from a re­search-fo­cused com­pa­ny to one try­ing to bring the pro­teome in­to the med­ical main­stream.

“There was the mo­ment, where I said I need to do this my­self,” Farokhzad told End­points, “and if I don’t I’m go­ing to re­gret it for the rest of my life.” 

Seer, So­ma­Log­ic, and a hand­ful of oth­er com­pa­nies work on what’s be­come known as the pro­teome. For decades, it had been tossed around as a bi­o­log­i­cal what-if, as se­duc­tive as it was un­at­tain­able. Per­haps in­stead of look­ing at DNA and RNA to un­der­stand the hu­man body and its dis­or­ders, we could look at the pro­teins that ge­net­ic code makes, the ones that in most cas­es ul­ti­mate­ly do the dam­age.

The hy­po­thet­i­cals were huge. In­stead of pre­dict­ing, based on ge­net­ics, if a 50-year-old had a pre­dis­po­si­tion to heart at­tacks or di­a­betes, a doc­tor could check if there had been ac­tu­al changes in the blood that built to those ail­ments. Phar­ma com­pa­nies could bet­ter un­der­stand how their drugs worked, and re­fine ac­cord­ing­ly.

One ob­sta­cle was math­e­mat­i­cal. With pro­teins, there are sim­ply far more pos­si­bil­i­ties. DNA has four let­ters and bonds in very spe­cif­ic ways and struc­tures: A-T, G-C, the dou­ble he­lix. Pro­teins are formed from up to 20 amino acids and can bond in myr­i­ad ways, and then change af­ter their cre­ation in­to a va­ri­ety of states de­pend­ing on what bonds to them.

“You ac­tu­al­ly need a lot of com­put­ing pow­er to cal­cu­late the the­o­ret­i­cal com­plex­i­ty you can cre­ate with pro­teins,” Farokhzad said. “You’ll nev­er get there.”

The oth­er prob­lem was chem­i­cal. DNA and RNA can be repli­cat­ed and am­pli­fied in a lab. Pro­teins can­not. In­stead, re­searchers have re­lied on bi­o­log­i­cal fish­ing ex­pe­di­tions. First, they used an­ti­bod­ies, which bind to pro­teins and make them eas­i­er to spot. But each an­ti­body on­ly binds to one pro­tein. Us­ing them to iden­ti­fy every hu­man pro­tein would be, as the New York Times’ Michael Be­har put it last year, “like try­ing to cat­a­log every fish in the ocean with a net that cap­tured on­ly a sin­gle species at a time.”

So­ma­Log­ic built it­self on the dis­cov­ery that nu­cle­ic acids called ap­tamers could be used to iden­ti­fy far more pro­teins at once. They built a data­base of 5,000 hu­man pro­teins, and then use ma­chine learn­ing to see how changes in those pro­teins’ struc­tures and quan­ti­ty cor­re­late with cer­tain health fac­tors. Af­ter decades of de­vel­op­ment and years of clin­i­cal tests, they launched their So­maSig­nal for med­ical prac­tices in Sep­tem­ber and bur­nished it with a De­cem­ber study in Na­ture that scanned 17,000 par­tic­i­pants for those 5,000 pro­teins and pre­dict­ed for di­a­betes and heart at­tack, among oth­er health is­sues.

Those who test­ed as high-risk could then be re­ferred to pre­ven­ta­tive mea­sures they may not oth­er­wise have re­ceived.

Stephen Williams came to So­ma­Log­ic in 2009 af­ter near­ly 20 years in ex­per­i­men­tal and clin­i­cal de­vel­op­ment at Pfiz­er

Click on the im­age to see the full-sized ver­sion

“We tried to de­vel­op 13 mod­els for 13 health is­sues, and we suc­ceed­ed with 11,” Williams said, adding they failed on­ly on weight pre­dic­tions and cur­rent di­et. “We re­al­ly an­swered the ques­tion: Can pro­teins be­come a sole in­for­ma­tion source?”

Farokhzad’s cri­tique is that this is a ‘bi­ased’ ap­proach: So­ma­Log­ic can on­ly look for the pro­teins it has ap­tamers for and it al­so can’t look deeply in­to spe­cif­ic changes. He said his Seer will be ‘un­bi­ased,’ rapid­ly iden­ti­fy­ing every pro­tein – at least 20,000 – and all the changes that can oc­cur with­in them and then use their own ma­chine learn­ing to find pat­terns. “Fast and broad,” he likes to call it.

“To re­al­ly un­der­stand pro­teomics, you have to do it in an un­bi­ased ap­proach,” he said.  “New bi­ol­o­gy is al­ways dri­ven by what we don’t know yet.”

Out in Red­wood City, Farokhzad has set up a Seer head­quar­ters with 40 em­ploy­ees and plans to ex­pand to 80 with the new fund­ing. He said they’ve spent the last year with their heads down try­ing to per­fect the sci­ence. Afraid biobanks might con­t­a­m­i­nate sam­ples with poor pro­ce­dures, they’ve set up 70 clin­i­cal sites na­tion­wide to build their data­base.

Oth­er folks have used an un­bi­ased ap­proach – help­ing build data­bas­es like the Hu­man Pro­teome Pro­ject, which now counts 19,823 pro­teins – but comb­ing through all those amino acids takes for­ev­er. Farokhzad has promised to make it fast enough to work with drug com­pa­nies (they al­ready have part­ners) and un­veil scans like those of­fered by So­ma­Log­ic.

If the tech holds up, it would have big im­pli­ca­tions for ear­ly de­tec­tion, un­veil­ing pre­vi­ous­ly hid­den changes in the body that presage dis­ease. Farokhzard claims it could help clin­i­cal tri­als, nam­ing Alzheimer’s and the hy­poth­e­sis that some of the drugs that failed might work if they treat a pa­tient ear­ly – at a stage we can’t yet de­tect. Like many in pro­teomics, he talks about it like a new fron­tier.

“We’re ba­si­cal­ly open­ing the flood­gate of ac­cess to pro­teom­ic in­for­ma­tion,” he said.

In So­ma­Log­ic’s view, though, that grand vi­sion isn’t nec­es­sary. All ap­proach­es are bi­ased, Williams said. The ques­tion is whether you can make pre­dic­tions that can be put to med­ical use.

“The ques­tion is whether you can mea­sure some­thing that is use­ful or ac­tion­able, not whether there’s some in­her­ent truth,” he said. “For our busi­ness, we don’t need to un­der­stand what the bi­ol­o­gy is. We let the ma­chine learn­ing pick out the best com­bi­na­tion of mea­sure­ments.”

Still, Williams said that when their long­time part­ner No­var­tis – which us­es So­ma­Log­ic’s tech to un­der­stand the mech­a­nisms of their drugs, among oth­er things – needs a high­er res­o­lu­tion look at what So­ma­Log­ic tech­nol­o­gy turns up, they di­rect them to a dif­fer­ent plat­form. Seer is de­vel­op­ing a com­mer­cial scan like So­ma­Log­ic’s and, like So­ma­Log­ic, even­tu­al­ly hopes to put out a (some­what con­tro­ver­sial) chip any­one can use, but their eas­i­est niche may be in drug de­vel­op­ment.

The in­dus­try will know soon enough. So­maSig­nal is on­ly avail­able in Col­orado for now, but a big­ger roll­out is pend­ing and they just hired a new com­mer­cial of­fi­cer. Af­ter two years in rel­a­tive ob­scu­ri­ty, Farokhzad said Seer will soon be open­ing up, and a prod­uct launch is sched­uled for 2021.

“Our tech­nol­o­gy risk is now large­ly put to rest and what lays ahead of us is ba­si­cal­ly prod­uct de­vel­op­ment and com­mer­cial­iza­tion,” he said.  “Now we’ve got to ex­e­cute.”

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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