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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Anirvan Ghosh, Unity CEO (via Facebook)

Uni­ty finds it­self with a fi­nite amount of cash as new da­ta pro­vide a ray of hope for in­vestors

It has not been an easy road for the anti-aging startup Unity Biotechnology. From staff cuts to a lead program loss, the company has run into several obstacles on its journey, but their latest news points to both the perils and potential ahead.

In the biotech’s Q2 results on Friday, the company revealed it has only enough cash to fund its operations through the first quarter of next year, with posted results showing that Unity had $64.5 million in cash and market securities at the end of the quarter. This is compared to the $79.2 million the biotech had at the end of March. The company also had an operating loss of $12.3 million for the quarter as well.