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.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

UP­DAT­ED: A mi­cro-cap with a po­ten­tial­ly promis­ing coro­n­avirus drug en­lists mask-skep­tic con­gress­man for DSMB

A small biotech that has talked up a potentially promising but unproven treatment for Covid-19 enlisted an unusual member for its study’s Data and Safety Monitoring Board: a sitting Republican congressman with close ties to the CEO and a history of mask skepticism.

NeuroRx, an Israeli biotech testing a lung inflammation drug in Covid-19 patients, tapped Maryland Rep. Andy Harris for the DSMB, Politico reported. Harris is an anesthesiologist but not a biostatistician, and he has questioned the CDC about a “cult of masks” in the US. Harris has known NeuroRx CEO Jonathan Javitt since the two worked at Johns Hopkins together over 20 years ago.

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Sean Bo­hen's break from bio­phar­ma is over. The ex-As­traZeneca CMO has re­tired his Big Phar­ma jer­sey and is now — hap­pi­ly — run­ning a lit­tle biotech

The last I had heard about Sean Bohen, he had stepped out of his high-profile job as chief medical officer at AstraZeneca at the beginning of 2019 as CEO Pascal Soriot triggered a broad-ranging R&D shakeup. And then, earlier this week, I got a chance to catch up.

It turns out that Bohen decided at the time that he would not just jump into a new job in the booming biopharma business. As an oncologist, he had worked on the big programs at AstraZeneca, and before that he was at Genentech. That was good for a ticket to just about anyplace in the big biopharma world. But he felt it was time to stop and think things through.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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