Trou­bled poop-test­ing start­up uBio­me an­nounces plans for liq­ui­da­tion

Your fa­vorite, fun-lov­ing, poop-test­ing, bac­te­ria-div­ing, un­der fed­er­al in­ves­ti­ga­tion, bank­rupt start­up with the pos­si­bly fun­da­men­tal­ly flawed sci­ence is — alas — shut­ting down.

uBio­me has filed to con­vert its Chap­ter 11 bank­rupt­cy in­to a Chap­ter 7 liq­ui­da­tion, all but spelling the end for a once soar­ing com­pa­ny that part­nered with re­searchers at Har­vard and Stan­ford and wooed Sil­i­con Val­ley in­vestors, but ul­ti­mate­ly found it­self ow­ing po­ten­tial­ly hun­dreds of mil­lions to health­care com­pa­nies, lay­ing off half of its staff and un­der fed­er­al in­ves­ti­ga­tion for its billing prac­tices.

The news comes bare­ly a year af­ter the com­pa­ny an­nounced an $83 mil­lion fund­ing round and the hir­ing of for­mer No­var­tis CEO Joe Jimenez to head a new R&D arm in Cam­bridge, MA.

What went wrong?

From their 2012 crowd-sourced found­ing un­til the first lay­offs came this Jan­u­ary, it seemed Ubio­me could do no wrong. They were 23andMe for your gut, a young com­pa­ny with young, telegenic founders of­fer­ing a warm face to a hot new sci­ence. They promised to map your mi­cro­bio­me, the 3-pound bac­te­r­i­al ecosys­tem sci­en­tists on­ly re­cent­ly dis­cov­ered had wide im­pacts on your health, from di­ges­tion to men­tal health. Their web­site home page sent “A warm wel­come to you. And your 39 tril­lion bac­te­ria.”

Their pre­mier ser­vice was Ex­plor­er. Orig­i­nal­ly priced at $400, it of­fered to test your stool sam­ple and give back all sorts of health-re­lat­ed ad­vice. Since then, they’ve widened their fo­cus to in­clude vagi­nal health and STDs women face.

But while their blog of­fered fun tips about di­et, sleep and “could your sum­mer fling change your mi­cro­bio­me?” some re­searchers were sound­ing alarms. They of­fered the same warn­ing re­searchers gave about 23andMe’s first for­ays in­to health-re­lat­ed ad­vice: It’s too soon and the sci­ence isn’t there. (23andMe has since gained FDA ap­proval for sev­er­al health-re­lat­ed ser­vices).

Ian Lip­kin Co­lum­bia

“I don’t think we know enough yet about the mi­cro­bio­me to be able to ad­vice peo­ple as to how they should mod­i­fy their di­et or change their lifestyles based on a kit of this sort,” Co­lum­bia epi­demi­ol­o­gist Ian Lip­kin told The At­lantic’s James Ham­blin in a 2016 video, of­fer­ing a 10-year time­frame for when the sci­ence will be ready.

In that video, uBio­me told the quite svelte Ham­blin that based on his test that he had the mi­cro­bio­me of an over­weight, de­pressed man. He did not con­firm the de­pres­sion sug­ges­tion.

The first sign of trou­ble came in Jan­u­ary, when the start­up cut 55 jobs out of its 300-per­son work­force, re­port­ed­ly to fo­cus on drugs and part­ner­ships. In May, founders Jes­si­ca Rich­man and Zac Apte were placed on leave as the FBI be­gan an in­quiry in­to the com­pa­ny’s billing process. This sum­mer, Busi­ness In­sid­er re­port­ed the com­pa­ny had laid off half its staff and that its sci­ence may have been flawed from the start.

They filled for Chap­ter 11 at the be­gin­ning of Sep­tem­ber. Court doc­u­ments re­vealed they may owe hun­dreds of mil­lions to health­care com­pa­nies, BI re­port­ed.

CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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For­mer Al­ler­gan pro­gram posts pos­i­tive topline PhI­II re­sults in pres­by­opia in an R&D win post-Ab­b­Vie merg­er

The battered pipeline AbbVie $ABBV acquired in its $63 billion buyout of Allergan picked up a rare win Wednesday morning.

Allergan announced that a pair of Phase III studies for an experimental ophthalmic solution in presbyopia, an age-related condition resulting in a problem focusing on nearby objects, met their primary endpoint in vision tests associated with the condition. The data puts the program on track for a NDA sometime in the first half of next year.

Managing partner Stefan Fischer (TVM)

Eli Lil­ly part­ner TVM Cap­i­tal rais­es $478M for their new life sci­ences fund, a 'sub­stan­tial' over­sub­scrip­tion

A German-Canadian VC fund and high-profile Eli Lilly partner has nearly half a billion dollars in new cash to play with.

TVM Capital Life Science, based out of Munich and Montreal, announced the closing of its second and latest fund Tuesday with $478 million in hand. That total represents a “substantial” oversubscription, managing partner Stefan Fischer said, and a good 36.5% more than the $350 million initially expected.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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