En­terome for­ti­fies Take­da re­la­tion­ship with $50M up­front to co-de­vel­op Crohn's drug

Pri­vate­ly held French biotech En­terome SA has scored a cool $50 mil­lion up­front to co-de­vel­op its ex­per­i­men­tal ear­ly-stage Crohn’s dis­ease drug with Take­da in its sec­ond col­lab­o­ra­tion with the Japan­ese drug­mak­er.

The mi­cro­bio­me-fo­cused En­terome — which al­ready boasts of col­lab­o­ra­tions with big Phar­ma play­ers such as John­son & John­son $JNJ, Bris­tol-My­ers $BMY — is set to work with Take­da $TKPYY in de­vel­op­ing EB8018, a small mol­e­cule de­signed to se­lec­tive­ly dis­arm vir­u­lent bac­te­ria in the gut that can cause in­flam­ma­tion, with­out dis­rupt­ing the lo­cal mi­cro­bio­me.

In­ter­est in har­ness­ing the mi­cro­bio­me — the ge­net­ic ma­te­r­i­al of all the mi­crobes such as bac­te­ria, fun­gi, and virus­es that live on and in­side the hu­man body — has ex­plod­ed in re­cent years, as emerg­ing ev­i­dence sug­gests these mi­crobes, par­tic­u­lar­ly those found in the gut, play a sig­nif­i­cant role in main­tain­ing health, pro­tect­ing against dis­ease and/or help­ing fight ill­ness. The glob­al mar­ket for mi­cro­bio­me ther­a­peu­tics is ex­pect­ed to sur­pass $890 mil­lion by 2025, es­ti­mates Per­sis­tence mar­ket re­search.

Com­pa­nies such as Seres and Re­bi­otix are rac­ing to de­vel­op so-called “crap­sules,” or pel­lets con­tain­ing healthy fe­cal mat­ter, as a less-icky al­ter­na­tive to fe­cal trans­plants typ­i­cal­ly fa­cil­i­tat­ed via a colonoscopy or en­e­ma, to trans­fer ‘good bac­te­ria’ as a last re­sort treat­ment for re­cur­rent clostrid­i­um dif­fi­cile, a stub­born bac­te­r­i­al in­fec­tion, among oth­er in­di­ca­tions. Da­ta al­so show mi­crobes can help de­press the im­mune sys­tem re­sponse in pa­tients with in­flam­ma­to­ry dis­or­ders, or ac­cel­er­ate it for dis­eases like can­cer. For in­stance, cer­tain bac­te­ria are use­ful against can­cer as they are be­lieved to smoothen the path for PD-1 im­munother­a­pies that are de­signed to take the brakes off the im­mune sys­tem, a mech­a­nism that Seres Ther­a­peu­tics is cur­rent­ly in­ves­ti­gat­ing in clin­i­cal tri­als.

En­terome has al­so made strides in this di­rec­tion. It inked a deal with Bris­tol-My­ers in 2016 to de­vel­op mi­cro­bio­me-de­rived di­ag­nos­tic tests as well as bio­mark­ers and po­ten­tial drugs to use in tan­dem with the U.S. drug­mak­ers im­munother­a­py plat­form.

In ad­di­tion to the up­front in­vest­ment for EB8018, Take­da has al­so pledged a fu­ture eq­ui­ty in­vest­ment on En­terome, the com­pa­nies said on Tues­day. If EB8018, which is cur­rent­ly in Phase I test­ing, meets cer­tain clin­i­cal, reg­u­la­to­ry and com­mer­cial mile­stones, it is al­so el­i­gi­ble to re­ceive an­oth­er hefty $640 mil­lion. If ap­proved, the prod­uct will be co-pro­mot­ed in the Unit­ed States un­der a prof­it/cost-shar­ing struc­ture. Take­da will be in charge of sell­ing the drug out­side the US, with En­terome el­i­gi­ble to re­ceive roy­al­ties on net sales in these ter­ri­to­ries.

The tie-up builds on a 2016 deal, in which the two com­pa­nies agreed to join forces to fo­cus on mi­cro­bio­me tar­gets across mul­ti­ple gas­troin­testi­nal dis­or­ders.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,900+ biopharma pros reading Endpoints daily — and it's free.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,900+ biopharma pros reading Endpoints daily — and it's free.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,900+ biopharma pros reading Endpoints daily — and it's free.