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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine -- so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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No­var­tis says Kym­ri­ah reach­es pri­ma­ry end­point in new PhII, al­though num­bers still to come

The race to develop CAR-T therapies has died down since Novartis’ Kymriah and Gilead’s Yescarta first crossed the finish line, though Tecartus also recently received approval. But the companies continue to expand their drugs’ applications, with Novartis preparing to conclude a new Phase II.

Interim data announced by the Swiss pharma show that Kymriah met its primary endpoint of complete response rate in treating patients with relapsed or refractory follicular lymphoma, the second-most common form of non-Hodgkin lymphoma. Based on preliminary trial findings, Kymriah had received RMAT designation from the FDA in April for r/r follicular lymphoma.

Ab­b­Vie shrugs off $134M cash deals, quit­ting a neu­ro R&D pact with Voy­ager Ther­a­peu­tics on vec­tor­ized an­ti­body treat­ments

It’s the end of the road for Voyager Therapeutics’ collaboration with AbbVie on tau and alpha-synuclein vectorized antibody development.

In two deals spanning the last two years, AbbVie dropped more than $134 million upfront for Voyager’s preclinical R&D of vectorized antibody treatments for diseases like Alzheimer’s and Parkinson’s. But Voyager says AbbVie is walking away now, without offering an explanation for why.

Mer­ck scoops up a PhII J&J dis­card in a bar­gain-base­ment deal. And this time they’re shoot­ing at NASH

When J&J turned to South Korea’s Hanmi for a GLP-1/glucagon dual receptor agonist obesity drug, the pharma giant paid $105 million in a cash upfront for the licensing rights and plotted a big clinical trial program to test it. A year ago, like a few of Hanmi’s big partners, J&J reviewed their trial data and walked away, handing it back.

Now Merck is stepping up to grab it for their NASH pipeline — and they got it a lot cheaper than J&J.

Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

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