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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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