Omid Farokhzad, Seer CEO

Seer rais­es an­oth­er $55M and fi­nal­ly re­veals pro­teom­ic tech — can it hold up?

Two years ago, Omid Farokhzad left his promi­nent nano-med­i­cine lab at Boston’s Brigham and Women’s Hos­pi­tal and moved across the coun­try to found a start­up off tech­nol­o­gy that, he said, could change the field of pro­teomics — and, with it, parts of med­i­cine, agri­cul­ture and a range of fields.

To­day, Farokhzad has fi­nal­ly re­vealed what that tech­nol­o­gy is. In a Na­ture Com­mu­ni­ca­tions pa­per, he showed how his com­pa­ny, Seer, and their lead prod­uct, called the Pro­teo­graph, can use nanopar­ti­cles to an­a­lyze the pro­tein com­po­si­tions in a sin­gle blood sam­ple, like a fish­ing net web­bing the con­tents of a par­tic­u­lar swath of sea. Or — to use the com­pa­ny’s pre­ferred metaphor — like a se­quenc­ing ma­chine read­ing out the base pairs on a par­tic­u­lar strand of DNA.

Along­side the pub­li­ca­tion, Seer al­so an­nounced a new $55 mil­lion round to help launch the prod­uct, bring­ing its to­tal fi­nanc­ing to over $150 mil­lion.

“We now en­able what was pre­vi­ous­ly not pos­si­ble,” Farokhzad told End­points News. “To­day about every 25 sec­onds, some­one [can] se­quence an­oth­er’s hu­man genome. This tech­nol­o­gy al­lows you to be­gin to in­ter­ro­gate the hu­man pro­teome in an un­bi­ased way, deep, in … speed and scale.”

It’s a bold talk for a field full of it, al­though it’s now at least bur­nished by peer-re­viewed da­ta — some­thing that can­not be said for all of Seer’s com­peti­tors. The pro­teome has long been a source of fas­ci­na­tion for sci­en­tists, for the sim­ple fact that we’re built of pro­teins, and changes in the con­cen­tra­tion or shape of pro­teins are what ul­ti­mate­ly un­der­lie changes in func­tion and dis­ease.

The prob­lem is that it’s far hard­er to get a com­plete pic­ture of some­one’s pro­teins than it is of their genes. Genes are com­par­a­tive­ly sim­ple: 4 base pairs, each of which can on­ly bind in one di­rec­tion. Pro­teins can be made of up to 20 amino acids that bind in myr­i­ad ways. They can al­so change af­ter trans­la­tion. The tech­no­log­i­cal or com­put­ing pow­er sim­ply did not ex­ist to an­a­lyze all of them at a rate com­pa­ra­ble to how re­searchers can an­a­lyze genes.

That’s changed to a de­gree in re­cent years. Sev­er­al com­pa­nies have popped up, most no­tably So­ma­Log­ic, of­fer­ing to screen peo­ple’s blood for a lim­it­ed set of pro­teins da­ta have in­di­cat­ed cor­re­lates with dis­ease. Re­searchers al­so have tech­niques to map out every pro­tein in a blood sam­ple, but it can take months.

Seer claims to be able to do screen­ing in a “fast and un­bi­ased way,” sim­i­lar to how we can now an­a­lyze genes — a quick and com­plete pic­ture. A new com­pa­ny, called Naut­lius, launched this year with over $100 mil­lion from promi­nent tech funds with a sim­i­lar promise, but they are ear­li­er stage and have yet to dis­close their tech. And every­one is com­par­ing them­selves to Il­lu­mi­na, the $60 bil­lion se­quenc­ing gi­ant, which it­self has a pro­teomics di­vi­sion.

Omead Os­tadan

“The key vari­able that next-gen se­quenc­ing and in par­tic­u­lar that Il­lu­mi­na tech­nol­o­gy changed was the abil­i­ty to ac­cess the genome or the tran­scrip­tome in an un­bi­ased, deep way, rapid­ly and at scale,” Omead Os­tadan, a for­mer Il­lu­mi­na ex­ec­u­tive who was re­cent­ly named Seer’s COO and pres­i­dent, told End­points. With Seer’s pro­teomics tech, “you en­able enor­mous depth and breadth anal­o­gous to the bi­o­log­ic in­sight that emerged when you could [first] ac­cess ge­nom­ic in­for­ma­tion.”

Seer has de­vel­oped over 250 nanopar­ti­cles for its Pro­teo­graph. These dif­fer­ent par­ti­cles, when put in the blood, at­tract dif­fer­ent pro­teins that bond to chem­i­cal groups on the sur­face, form­ing a “coro­na,” or a kind of mol­e­c­u­lar ha­lo around the pro­tein. Oth­er pro­teins then bind to those pro­teins and so on. Not every nanopar­ti­cle will bind to every pro­tein, but if you put in enough, the dif­fer­ent coro­nas will give a kind of pic­ture both of what pro­teins ex­ist and if those pro­teins have changed shape.

As a proof of con­cept, the com­pa­ny looked at sam­ples from ear­ly-stage non-small cell lung can­cer pa­tients and found pro­teins that cor­re­lat­ed with dis­ease.

This kind of analy­sis, Farokhzad said, could be used to di­ag­nose pa­tients ear­ly — a goal shared by well-backed liq­uid biop­sy com­pa­nies like GRAIL and Kar­ius. It could al­so, he said, be used to find new pro­teins as­so­ci­at­ed with can­cer, and those pro­teins could then be­come bio­mark­ers or tar­gets for new ther­a­pies. There are al­so ap­pli­ca­tions in agri­cul­ture and en­vi­ron­men­tal sci­ence.

For now, the com­pa­ny is fo­cused on build­ing new nanopar­ti­cles and launch­ing the prod­uct next year, be­fore find­ing new ap­pli­ca­tions. They’ll have to seal part­ners and buy­ers, who in turn will be able to say if the prod­uct is just as trans­for­ma­tion­al as they claim.

“It sounds sim­ple, but hav­ing lived through prod­uct de­vel­op­ment and com­mer­cial­iza­tion, there’s a lot to do,” Os­tadan said.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Eric Shaff (Seres)

Af­ter a 4-year so­journ, a strug­gling mi­cro­bio­me pi­o­neer claims a break­out PhI­II come­back. And they're tak­ing it straight to the FDA

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Ko­dak's $765M deal is on hold un­til al­le­ga­tions are cleared — US gov­ern­ment

Just two weeks after Trump administration officials toured Kodak’s Eastman Business Park, signed a letter of interest for a $765 million loan designed to spur domestic pharmaceutical manufacturing on a socially distanced stage and posed for photos with the company CEO, they’re putting the deal on hold.

The US International Development Finance Corporation announced the halt in a brief tweet just before market closed, tanking the stock 7.64% within minutes. Kodak shares plunged 42.81% to $8.51 Monday in pre-market trading — still multitudes higher than where it was for years prior.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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