Atre­ca banks a $125M mega-round as it builds a pipeline of an­ti­bod­ies for can­cer and pon­ders IPO tim­ing

In an­oth­er sign that the mon­ey back­ing up­start biotechs — and the val­ue at­tached to new drugs — con­tin­ues to swell, Red­wood City, CA-based Atre­ca to­day is pulling back the cov­ers from a $125 mil­lion mega-round de­signed to get through the ini­tial pre­clin­i­cal phase of de­vel­op­ment.

John Or­win

The work at Atre­ca cen­ters on a plat­form tech that takes tis­sue sam­ples from can­cer pa­tients to ex­plore for ide­al an­ti­bod­ies, us­ing B cells as their sound­ing board. If that seems fa­mil­iar, that’s be­cause it’s the same ba­sic tech ap­proach that Seat­tle-based On­coRe­sponse is us­ing, as I re­port­ed ear­li­er in the week with their $40 mil­lion round.

“These an­ti­bod­ies form in the con­text of the pa­tients’ re­sponse, but the anti­gens they’re tar­get­ing are not unique to the pa­tient,” Atre­ca CEO John Or­win tells me. In­stead, they’re af­ter a broad pa­tient pop­u­la­tion that can ben­e­fit. And they’re sleuthing sam­ples in ways that should de­liv­er ex­per­i­men­tal ther­a­pies that can be used to tar­get a va­ri­ety of can­cer types — an­oth­er com­mon strat­e­gy in the field.

The CEO notes that the B cells they in­ter­ro­gate “are ex­treme­ly in­for­ma­tion-rich cells” that re­searchers can use to “cap­ture the se­quence in­for­ma­tion used in bioin­for­mat­ics to turn in­to reagents with an eye to de­vel­op­ing an­ti­bod­ies.”

“It’s the way we gen­er­ate the da­ta and the way we use the da­ta to se­lect what we take in­to pre­clin­i­cal test­ing and the way we do pre­clin­i­cal test­ing that we think gives us sig­nif­i­cant com­pet­i­tive ad­van­tages,” he adds.

By ramp­ing up an in­dus­tri­al ap­proach to the plat­form, Or­win — who helmed Re­lyp­sa un­til its $1.53 bil­lion buy­out — and his crew of 65 at Atre­ca are al­so as­sem­bling a pipeline of ther­a­pies that should in­clude plen­ty of can­di­dates for new bis­pecifics and an­ti­body-drug con­ju­gates as well.

Their first Phase I should get un­der­way next year, says the CEO. The $125 mil­lion should last in­to 2020, giv­ing Atre­ca some breath­ing room in 2019 to con­sid­er the right time for an IPO.

Cur­rent­ly on its third round, Atre­ca’s lead in­vestor is stay­ing qui­et for now. That’s a bit un­usu­al at this stage of the game for a round this size. But there were plen­ty of in­vestors in the syn­di­cate who were ready to flag their par­tic­i­pa­tion. They in­clude Welling­ton Man­age­ment Com­pa­ny and Cor­morant As­set Man­age­ment, based in Boston. New in­vestors Ais­ling Cap­i­tal, Box­er Cap­i­tal of the Tavi­s­tock Group, EcoR1 Cap­i­tal, Red­mile Group, Sam­sara Bio­Cap­i­tal, and funds man­aged by Tekla Cap­i­tal Man­age­ment al­so pitched in.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Yanay Ofran (L) and Anat Binur (Ukko)

Leaps by Bay­er backs a pro­tein en­gi­neer­ing start­up tak­ing on Aim­mune — and Nestlé — in peanut al­ler­gy

Little capsules of peanut powder drove Nestlé’s $2.6 billion buyout of Aimmune. Now, with $40 million in new funding, a fledgling biotech is promising to bring a more sophisticated version of that protein therapy that can go much, much further.

Ukko’s goal is two-pronged — with the initial products spanning therapeutic and food — but it’s grounded in the same protein engineering platform, co-founder and CEO Anat Binur told Endpoints News.

As tar­get­ed ther­a­pies get ever more pre­cise, Deer­field un­veils $50M bet on an Har­vard pro­fes­sor's chem­istry in­sights

Behind the seemingly simple concept of targeted cancer therapies is the drug developer’s headache that the target is always changing. Each generation of kinase inhibitors may be ostensibly hitting the same oncogene, but in addition to blocking the wildtype oncogene, they must now also address the mutations that have developed along the way, spurring resistance to current drugs.

The more those target kinases evolve, too, the more they could resemble off-target kinases you don’t want to bind. So each iteration requires more selectivity — sometimes down to differences of a few atoms.

Vincent Sandanayaka (file photo)

UP­DAT­ED: Ex-MD An­der­son chief De­Pin­ho is help­ing launch an­oth­er biotech — and he's stick­ing with fa­mil­iar ground

Years after co-founding SINE-focused Karyopharm and stirring up controversy at MD Anderson, Ronald DePinho is helping uncloak a new biotech targeting solute carrier transporter proteins — and Karyopharm’s former head of chemistry is leading the charge.

Nirogy Therapeutics emerged from stealth mode on Tuesday with a $16.5 million Series A round and plans to hit the clinic by 2022. The financing should be enough to carry the startup’s lead program, a small molecule lactate transport inhibitor, through Phase I, CEO Vincent Sandanayaka said.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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