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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

Endpoints Premium

Premium subscription required

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

Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,200+ biopharma pros reading Endpoints daily — and it's free.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,200+ biopharma pros reading Endpoints daily — and it's free.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,200+ biopharma pros reading Endpoints daily — and it's free.

Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.