Ge­nomics meets blockchain: Har­vard team fea­tur­ing George Church launch­es peer-to-peer genome se­quenc­ing start­up

George Church

George Church has long ad­vo­cat­ed for big da­ta in ge­nomics; his lab at Har­vard pi­lot­ed a project to col­lect and share vol­un­teers’ ge­nom­ic da­ta for col­lab­o­ra­tive re­search. Now, with two oth­er Har­vard-con­nect­ed founders, he’s tak­ing the shar­ing one step fur­ther by in­cor­po­rat­ing blockchain, the ledger sys­tem most fa­mous for pow­er­ing Bit­coin.

Neb­u­la Ge­nomics emerged from stealth mode Wednes­day with a whitepa­per — not a press re­lease — de­tail­ing its vi­sion. In that world, any­one can se­quence their genome at a low cost, glean in­sights from the re­sults, and have to­tal con­trol on what they want to do with them.

Cur­rent per­son­al ge­nomics play­ers like He­lix and 23andMe adopt a mod­el where the com­pa­nies func­tion as a mid­dle­man be­tween in­di­vid­u­als who want da­ta about their genome and phar­ma com­pa­nies will­ing to pay for that da­ta to use in drug de­vel­op­ment. Neb­u­la says it doesn’t want to be that mid­dle­man. In­stead, the in­di­vid­ual would be in the mid­dle in­ter­act­ing with both Neb­u­la and phar­ma com­pa­nies on a Neb­u­la-built plat­form.

To be sure, Neb­u­la is not the first com­pa­ny to mar­ry blockchain to ge­nomics. Lu­na DNA, a San Diego start­up found­ed by for­mer ex­ec­u­tives of genome se­quenc­ing gi­ant Il­lu­mi­na, is al­so build­ing a DNA data­base with blockchain. The key dif­fer­ence is that Lu­na would pay cus­tomers (in Lu­na coins) for the da­ta that it even­tu­al­ly sells to phar­mas, while Neb­u­la would stay out of the di­rect buy­ing and sell­ing, on­ly of­fer­ing an in­fra­struc­ture in which genome se­quenc­ing would be es­sen­tial­ly sub­si­dized.

Ac­cord­ing to the white pa­per, this ap­proach will re­sult in low­er se­quenc­ing costs (as com­pa­nies would es­sen­tial­ly sub­si­dize in­di­vid­u­als for the tests); more se­cure da­ta pro­tec­tion (blockchain is en­crypt­ed and anony­mous); and more ef­fi­cient da­ta ag­gre­ga­tion.

“It’s a new ap­proach to chal­lenges of ge­nomics, in­clud­ing se­quenc­ing costs, ge­net­ic da­ta pro­tec­tion, da­ta man­age­ment, and ge­nomics big da­ta,” Church told STAT.

Den­nis Gr­ishin

So what would the process look like? First off, the ac­tu­al se­quenc­ing will be done by Ver­i­tas Ge­net­ics, an­oth­er Church start­up. The pay­ment is where it gets fuzzy. The idea is cus­tomers would pay for the se­quenc­ing da­ta with Neb­u­la to­kens, its in-house cryp­tocur­ren­cy, which would be sold to phar­ma com­pa­nies for cash. The to­kens then cir­cu­late back to the cus­tomers as phar­ma com­pa­nies use them to pay for per­son­al da­ta. It’s un­clear how the cus­tomers would get the to­kens in the first place; whether to­kens would be of any val­ue to some­one who’s al­ready had their genome se­quenced al­so re­mains a ques­tion.

“We are not an­nounc­ing any to­ken sale at the mo­ment,” co-founder Den­nis Gr­ishin told STAT. “A to­ken is nec­es­sary for the func­tion­al­i­ty of our pro­to­col, but we have not de­cid­ed yet how they will be dis­trib­uted.”

Neb­u­la is now op­er­at­ing on an ini­tial $600,000 in­vest­ment from an an­gel in­vestor, Gr­ishin al­so said, and they ex­pect to have raised an ad­di­tion­al $1 mil­lion by the end of the week.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Alan Wise (L) and Peter Trill (Duke Street Bio)

They sold their last biotech to Mer­ck. Now they're back with a PARP out­fit named af­ter a Lon­don street

In 2016, Peter Trill and Alan Wise sold IOmet Pharma (an I/O outfit as the name suggests) to Merck for $400 million.

Now, some six years later, the duo has returned with another cancer biotech, Duke Street Bio, that emerged from stealth Tuesday. Duke Street Bio, named for the street where it’s located in London, is making its public debut as a next-gen PARP player, hoping to break into a field that already has a number of Big Pharma competitors.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”