Roche and Take­da try on Em­u­late’s 'or­gan chip' tech for R&D

Two phar­ma gi­ants — Roche and Take­da — are buy­ing in­to a drug test­ing tech­nol­o­gy that wants to be the next gen­er­a­tion’s “lab rat,” ink­ing part­ner­ships with the tech’s mak­er to in­tro­duce the sys­tems to their R&D labs.

The tech, made by Wyss In­sti­tute spin­off Em­u­late, in­cludes small chips de­signed to hold liv­ing cells in cham­bers. These chips are en­gi­neered to recre­ate the en­vi­ron­ment cells might ex­pe­ri­ence in the hu­man body, in­tro­duc­ing me­chan­i­cal forces that mim­ic breath­ing, for ex­am­ple.

Geral­dine Hamil­ton

Test­ing drugs in cells that are in dish­es — or even test­ing drugs in an­i­mals — is a flawed process, Em­u­late’s pres­i­dent and CSO Geral­dine Hamil­ton tells me. An­i­mals are not hu­mans, and so they of­ten fail to pre­dict how drugs will per­form in pa­tients. And cells in dish­es don’t work like they do in the hu­man body, so they aren’t very pre­dic­tive ei­ther.

Com­pa­nies have been work­ing on bet­ter ways to test drugs for a while, with com­pa­nies like San Diego-based Organo­vo “bio­print­ing” hu­man tis­sue and Ste­moniX build­ing “mi­cro or­gans” by struc­tur­ing hu­man iP­SC-de­rived cells in­to mi­cro­tis­sues.

But Hamil­ton says both these tech­nolo­gies are lack­ing.

“There are key fac­tors miss­ing: me­chan­i­cal forces, dy­nam­ic flow sys­tems, cir­cu­lat­ing im­mune cells,” she says. “While they re­tain some nice bi­olo­gies, they’re miss­ing these el­e­ments.”

Em­u­late’s S-1 Or­gan-Chip tech­nol­o­gy. Pho­to cour­tesy of Em­u­late.

Now Roche and Take­da are pay­ing to take Em­u­late’s tech for a test dri­ve. Roche will use Em­u­late’s Hu­man Em­u­la­tion Sys­tem across mul­ti­ple R&D pro­grams in a three-year part­ner­ship, with the aim of dis­cov­er­ing and de­vel­op­ing new class­es of ther­a­peu­tic an­ti­bod­ies and drug com­bi­na­tions. One goal of the part­ner­ship is to use pa­tient-de­rived cells to make head­way on the idea of per­son­al­ized drug safe­ty, us­ing the chips to test how a pa­tient or pa­tient group might re­spond to a drug. Sci­en­tists from both com­pa­nies will work with­in Em­u­late’s labs in Boston. The re­search will ini­tial­ly fo­cus on us­ing Em­u­late’s “Lung-Chip” and “Brain-Chip,” with the op­por­tu­ni­ty to ex­pand to use oth­er “Or­gan-Chips.”

Take­da is specif­i­cal­ly us­ing Em­u­late’s “In­stes­tine-Chip” for gas­troin­testi­nal dis­ease R&D.

“The abil­i­ty to ac­cu­rate­ly mod­el the in­testi­nal ep­ithe­li­um is a key to open­ing up new in­sights in­to the com­plex path­ways of GI dis­eases and drug mech­a­nisms of ac­tion, and we are de­light­ed to ap­ply our In­tes­tine-Chip to sup­port drug in­no­va­tion with Take­da, a world leader in de­vel­op­ing treat­ments for GI dis­eases,” Hamil­ton said.

Fi­nan­cial de­tails of the part­ner­ships were not dis­closed.


Vil­li-like struc­tures in­side Em­u­late’s In­tes­tine-Chip, which will be used by Take­da in new part­ner­ship. Em­u­late

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Roche's headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

Roche ditch­es fi­nal PhI­II for can­cer hope­ful, re­ports set­back for key drug in $1.4B buy­out

Over the past few years, Roche has released news about its AKT inhibitor ipatasertib in drips — most of them negative. The drug yielded mixed data in a key prostate cancer trial, Phase III flops in triple-negative breast cancer forced the pharma giant to pull the plug there, and in mid-2022 Roche trimmed two more early-stage indications in prostate cancer after completing the trials.

Now, the last piece of the program is gone.

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Simba Gill, Evelo Biosciences CEO

Sim­ba Gill stay­ing on at Evelo to weath­er lay­offs and a PhII fail

Simba Gill will be staying put as CEO of Evelo Biosciences for now.

Gill announced last year that he would be leaving the head position at Evelo to take on the role of executive partner at Flagship Pioneering. He was aiming to stay on until a successor was selected, but there’s a new course of action in the wake of a Phase II miss and a reduced headcount.

“I want to emphasize that I remain personally committed to Evelo and staying on to lead the organization. I continue to believe that Evelo is a remarkable opportunity in terms of the science, the platform, the type of products that we’re able to produce, and most importantly, the potential of millions of patients suffering from all stages of inflammatory disease,” Gill said on a conference call.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.