Take­da inks up to $500M col­lab­o­ra­tion with ex­tra-cel­lu­lar ma­trix biotech for NASH

With Take­da’s mass, over-the-counter sell-off near­ing com­ple­tion, the Japan­ese drug­mak­er is beef­ing up the dis­cov­ery en­gine it wants to be the core part of the post-Shire com­pa­ny. On Tues­day, that meant their most re­cent for­ay in­to NASH — a dis­ease that they have tried with lit­tle ad­vanced suc­cess to de­vel­op drugs for in the past, but which re­mains a gold-mine for any com­pa­ny that can find an ef­fec­tive ther­a­py.

Take­da signed a col­lab­o­ra­tion to­day with Lon­don-based biotech En­gi­tix to de­vel­op drugs for ad­vanced fi­brot­ic liv­er dis­eases, in­clud­ing NASH. Up­front pay­ments weren’t dis­closed but En­gi­tix will be el­i­gi­ble for up to $500 mil­lion in mile­stones.

The deal emerges out of En­gi­tix’s on­go­ing work with Take­da. Take­da spon­sored the 4-year-old start­up with a Lab­Cen­tral “Gold­en Tick­et” last year, giv­ing them ac­cess to lab space, lab per­son­nel, and de­vel­op­ment pro­grams in Cam­bridge. The idea now is to com­bine En­gi­tix’s ex­tra-cel­lu­lar ma­trix plat­form with Take­da’s ex­pe­ri­ence in gas­troen­terol­o­gy.

En­gi­tix is based on the idea that com­pa­nies of­ten fail to trans­late their pre­clin­i­cal work be­cause they use cell lines that don’t take in­to ac­count that ma­trix — the net­works of pro­teins and car­bo­hy­drates that pass be­tween cells, com­mu­ni­cat­ing and as­sur­ing the whole sys­tem func­tions. So far, they’ve built ECM mod­els by tak­ing re­sect­ed tis­sues, break­ing them down “de­cel­lu­lar­iz­ing” them — lit­er­al­ly re­mov­ing the cells — and then lat­er grow­ing cell lines in what’s left­over.

Al­though the com­pa­ny is al­so fo­cused on sol­id tu­mors, the first pub­li­ca­tion on their plat­form, in Sci­en­tif­ic Re­ports, was a pa­per on the first suc­cess­ful de­cel­lu­lar­iza­tion and re­pop­u­la­tion of a hu­man liv­er ex­tra-cel­lu­lar ma­trix.  The com­pa­ny’s lead in­di­ca­tions are in pri­ma­ry scle­ros­ing cholan­gi­tis and NASH, al­though both re­main in the dis­cov­ery phase.

The deal hard­ly marks Take­da’s first ear­ly-stage biotech tie-in for NASH. In 2016, they teamed up for an undis­closed sum with the RNA biotech Arc­turus on NASH and GI dis­cov­ery, and ten months lat­er, they signed an up to $470 mil­lion deal with He­mo­S­hear to use their dis­ease mod­el­ing plat­form for liv­er tar­gets.

So far, those have yet to yield any clin­i­cal can­di­dates or named pre-clin­i­cal can­di­dates, ac­cord­ing to the com­pa­ny’s of­fi­cial pipeline and the data­base on clin­i­cal­tri­als.gov. Still, Take­da opt­ed to ex­pand both part­ner­ships in 2018 and 2019, adding in last year’s He­mo­S­hear re­lease that their ef­forts have yield­ed sev­er­al pre­clin­i­cal can­di­dates.

With the ma­jor clin­i­cal NASH can­di­dates tak­ing hit af­ter hit, the Japan­ese drug­mak­er may have plen­ty of time to de­vel­op those. Lead­er­ship has been seek­ing to move to­ward in­no­va­tion and high-prof­it prod­ucts. The first drug for a dis­ease es­ti­mat­ed to af­fect mil­lions of Amer­i­cans would cer­tain­ly fit the bill.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Joan Butterton, Merck Research Laboratories VP of global clinical development, infectious diseases (Merck)

Mer­ck­'s ex­per­i­men­tal HIV drug is­la­travir hits with a PhI­II com­bo win and FDA fil­ing plans

Back in March, Merck and Gilead agreed to a partnership to challenge GlaxoSmithKline on long-acting HIV meds — by combining one drug from both Merck and Gilead that had shown potential. While Gilead brought its capsid inhibitor lenacapavir, Merck brought islatravir into the deal — a small molecule that the pharma acquired in 2012 from a small Japanese firm.

While that partnership is ongoing, islatravir is coming out of 2 Phase III pivotal trials with back-to-back successes and plans to beat a quick advance to the FDA.

Gil Beyen, Erytech CEO

A transat­lantic biotech flags a painful PhI­II can­cer flop, wav­ing a white flag

More than 4 years after little Erytech inflated some rare passion for its stock with upbeat Phase IIb data for their lead drug in pancreatic cancer, they’ve let the air out of the party balloons.

The transatlantic biotech $ERYP put the word out Monday morning that its drug eryaspase flopped in a Phase III pivotal for second line metastatic pancreatic cancer, slamming its stock, which plunged more than 30%.

Preston Klassen, Metacrine CEO

An­oth­er NASH play­er re­treats from bat­tered field af­ter tox­i­col­o­gy study flags po­ten­tial de­lay

NASH, the notorious liver disease afflicting an increasing number of Americans, has always been the focus at Metacrine ever since serial entrepreneur Rich Heyman unveiled the first round of financing all the way back in 2015.

Not anymore.

The San Diego-based biotech is halting its NASH program and choosing instead to prioritize its effort in pushing the same FXR agonist, MET642, into a Phase II trial for inflammatory bowel disease.