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

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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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

UP­DAT­ED: Eli Lil­ly toss­es a mar­quee pain drug and hits the gas on Alzheimer’s — as Bio­gen’s suf­fer­ing opens mar­ket to ri­vals

The furious chorus of critics that brought sales of Biogen’s ultra controversial Alzheimer’s drug aducanumab (sold as Aduhelm) to a near halt is opening up some big opportunities for a major league rival that has long sought the lead role in this largely untapped megamarket.

In its Q3 update today, Eli Lilly — noted for its dogged persistence in attempting for years to get solanezumab across the FDA finish line — said that it has begun a rolling submission of its rival Alzheimer’s drug donanemab in search of an accelerated approval. Anne White, senior VP of Lilly’s neuroscience unit, acknowledged during the investor call the challenges Biogen has faced with uptake and noted Lilly may face similar hurdles.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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