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.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”

Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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