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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

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De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Henrietta Lacks

UP­DAT­ED: Fed­er­al judge weighs mo­tion to dis­miss HeLa law­suit against Ther­mo Fish­er

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.