Mi­cro­bio­me play­er uBio­me puts founders on leave, in­ter­im CEO promis­es to as­sist in fed­er­al probe

When Joe Jimenez signed on to the board at uBio­me last fall, the new­ly ex-No­var­tis chief was clear­ly hop­ing to put the con­tro­ver­sy over his re­la­tion­ship with Pres­i­dent Trump’s per­son­al at­tor­ney — Michael Co­hen — be­hind him and start a new chap­ter in his sto­ried ca­reer.

Joe Jimenez

In­stead, he’s found him­self in­volved in a fresh scan­dal in­volv­ing an FBI in­ves­ti­ga­tion in­to uBio­me’s billing prac­tices. To­day, the com­pa­ny’s founders who re­cruit­ed Jimenez, Jes­si­ca Rich­man and Zac Apte, have been placed on leave while gen­er­al coun­sel John Rakow steps up as in­ter­im CEO in charge of an in­ter­nal in­ves­ti­ga­tion.

John Rakow

In a state­ment out Wednes­day af­ter­noon, Rakow said:

As in­ter­im CEO of uBio­me, I want all of our stake­hold­ers to know that we in­tend to co­op­er­ate ful­ly with gov­ern­ment au­thor­i­ties and pri­vate pay­ors to sat­is­fac­to­ri­ly re­solve the ques­tions that have been raised, and we will take any cor­rec­tive ac­tions that are need­ed to en­sure we can be­come a stronger com­pa­ny bet­ter able to serve pa­tients and health­care providers.

The Wall Street Jour­nal first re­port­ed a few days ago about the fed­er­al probe.

Jes­si­can Rich­man

Billing it­self as the “lead­ing mi­cro­bial ge­nomics com­pa­ny,” uBio­me was launched 6 years ago from its base in the Bay Area, mar­ket­ing a pair of con­sumer tests that can do at-home tests on your gut or the STDs that women face, like chlamy­dia and gon­or­rhea. When I talked to Rich­man last fall, the com­pa­ny said it had raised $83 mil­lion from ven­ture back­ers — led by OS Fund — in a new dri­ve to join the pack de­vel­op­ing mi­cro­bio­me ther­a­pies. 

A few months lat­er, though, uBio­me was al­ready lay­ing off em­ploy­ees from its staff of some 300, say­ing it want­ed to fo­cus more on drugs and part­ner­ships with drug com­pa­nies, where Jimenez could help.

Zac Apte

I nev­er got a chance to talk to Jimenez last fall, but he told one oth­er writer that he had put the Co­hen af­fair be­hind him and moved on. Dur­ing his last year as CEO, No­var­tis paid Co­hen $1.2 mil­lion for what it said was a brief con­sult­ing pe­ri­od as they sought to learn more about Trump’s health­care pol­i­cy.

The mon­ey, though, went in­to the same ac­count that paid porn ac­tress Stormy Daniels hush mon­ey. And when that emerged, the phar­ma gi­ant and Jimenez were caught in one of the ugli­est scan­dals to hit Wash­ing­ton DC.

Co­hen told law­mak­ers that No­var­tis had want­ed him to open a back door to the White House, seek­ing help in mak­ing con­nec­tions with the top play­ers in the ad­min­is­tra­tion. He re­fused, and while No­var­tis paid out the con­tract, they even­tu­al­ly stopped talk­ing. By that time, No­var­tis spokes­peo­ple had shut the win­dow on com­ments.

A new at­tempt to reach Jimenez this af­ter­noon has so far been un­suc­cess­ful.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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