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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

Harpreet Singh, Immatics CEO

Im­mat­ics an­nounces mul­ti­ple pipeline changes with lat­est fi­nan­cial re­sults

The T-cell biotech Immatics is looking to make some changes to its pipeline.

Immatics released its 2022 financial results on Tuesday and announced that it’s planning to discontinue its program for IMA201, an experimental cell therapy for solid tumors that express the antigens known as MAGE4/8. It plans to shift focus to IMA401, a TCR bispecific which goes after the same target.

The German-based biotech said it will treat the remaining patients enrolled in the program before the discontinuation. No other reasons were given for the discontinuation. Endpoints News reached out to Immatics for more details but did not receive a response by press time.

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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