Valo CEO David Berry (Flagship Pioneering)

Koch's 'dis­rup­tive' VC bets $110M on one of Flag­ship's new, big com­pu­ta­tion­al star­tups

David Berry joined Flag­ship as a Har­vard and MIT wun­derkind in 2005 and by now he’s been at the firm al­most as long as any­one not named Noubar. He’s played a hand in some of their biggest star­tups, in­clud­ing Seres, Omega, KSQ, Evelo and, of course, Mod­er­na.

Flag­ship is known for its flash, but over the last cou­ple years, Berry has been qui­et­ly build­ing a com­pu­ta­tion­al start­up in Boston that he thinks can re­make drug de­vel­op­ment in a way that, for all the buzz, ma­chine learn­ing and ar­ti­fi­cial in­tel­li­gence have yet to do.

He’s man­aged to con­vince at least a few in­vestors of that vi­sion, rais­ing $100 mil­lion in a Se­ries A, $50 mil­lion in an undis­closed fi­nanc­ing and a $190 mil­lion in a Se­ries B de­spite re­main­ing far from the clin­ic. On Tues­day, Va­lo re­vealed an­oth­er in­vestor who bought in, adding $110 mil­lion from Koch Dis­rup­tive Tech­nol­o­gy, the ven­ture cap­i­tal arm of the famed and in­fa­mous hold­ing com­pa­ny Koch In­dus­tries.

Koch Dis­rup­tive Tech­nolo­gies has in­vest­ed in a broad swatch of tech com­pa­nies but not yet wad­ed deeply in­to biotech. In back­ing Va­lo, they are buy­ing in­to what Berry says is a new way of think­ing about drugs and tech and da­ta.

“As we look at the process that ex­ists in drug de­vel­op­ment or drug dis­cov­ery to­day, it’s ef­fec­tive­ly a point-to-point process and each of the steps has its own da­ta, its own way of mak­ing de­ci­sions,” Berry told End­points News. “As the drug moves through its var­i­ous steps, it’s as if it’s been thrown over a wall.”

AI and ma­chine learn­ing have large­ly been de­ployed at in­di­vid­ual steps of the drug de­vel­op­ment process: used by Atom­wise, for ex­am­ple, to screen mas­sive li­braries for the best mol­e­cule, or by In­sitro to find the dif­fer­ence be­tween dis­eased and healthy cells, and the places where de­vel­op­ers might be able to in­ter­vene and turn one to the oth­er. Sep­a­rate­ly, large phar­mas and small biotechs like Black­Thorn have used ma­chine learn­ing to de­sign tri­als and find the best pa­tients.

Berry ar­gues that we need a bet­ter sys­tem — a bet­ter plat­form — that can in­te­grate all those var­i­ous sources and ap­pli­ca­tions of da­ta from the out­set, al­low­ing com­pa­nies to over­come the hur­dles that tend to ap­pear as a drug goes through de­vel­op­ment. And that da­ta should be ground­ed in hu­mans (as op­posed to mice or mon­key ex­per­i­ments) to in­crease the odds that ba­sic lab in­sights ac­tu­al­ly trans­late in­to the clin­ic.

With about 110 em­ploy­ees, large amounts of hu­man da­ta, in­clud­ing what they claim is the “largest and most-de­tailed car­dio-meta­bol­ic dataset in the world,” and reams and reams of cloud space, they’ve built a plat­form they call Opal to do that.

For ex­am­ple, Berry claimed, they’ve de­vel­oped an al­go­rithm that al­lows them to pre­dict the tox­i­col­o­gy of any giv­en com­pound with 86% ac­cu­ra­cy. They al­so use 3D physics soft­ware to sim­u­late and de­sign mol­e­cules, adopt­ing a sim­i­lar ap­proach to the well-part­nered com­pu­ta­tion­al biotech Schrödinger, which has long ar­gued that the AI al­go­rithms many star­tups use to screen for mol­e­cules strug­gle be­cause they re­ly on 2D im­ages of 3D mol­e­cules.

“When you ask the com­put­er to try learn that a 2D im­age rep­re­sents a 3D struc­ture — that’s a very hard thing for a com­put­er to learn,” Berry said.

To find new tar­gets, the plat­form and Va­lo’s sci­en­tists com­bine “omics” da­ta – ge­nomics, pro­teomics, even the much less talked about metabolomics — with da­ta that track how pa­tients change as they age and their dis­eases progress or wane. “Dis­eases are dy­nam­ic,” he said.

Va­lo will use the new pro­ceeds to con­tin­ue hir­ing a few dozen more em­ploy­ees and progress the plat­form. With two years of run­way, it will al­so give them the cash to get in­to the clin­ic, Berry said. Al­though they haven’t gone deep in­to de­tails, Va­lo did re­lease their first batch of can­cer tar­gets ear­li­er this year: NAMPT, PARP1, USP28 and HDAC3.

Their tar­gets for neu­rode­gen­er­a­tion and car­dio­vas­cu­lar dis­ease re­main undis­closed.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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