Promis­ing au­toim­mune biotech bought out as celi­ac drug heads for the clin­ic with a fresh in­fu­sion of cash

Af­ter four years of pre­clin­i­cal work, one of the more promis­ing com­pa­nies in the hunt for a drug to treat celi­ac dis­ease is get­ting bought out by a part­ner, which will now get a new in­fu­sion of cash to dri­ve the lead drug in­to its first clin­i­cal tri­als.

Kanyos Bio, orig­i­nal­ly formed in 2015 in a col­lab­o­ra­tion be­tween the Cam­bridge-based Swiss biotech Anokion and the Japan­ese Astel­las, has been ac­quired by Anokion, which land­ed $40 mil­lion in Se­ries B fi­nanc­ing to bring its Kan-101 pro­gram in­to clin­i­cal tri­als. The plat­form us­es an anti­gen-spe­cif­ic treat­ment to tar­get the au­to-im­mune dis­ease of­ten pop­u­lar­ly thought of as a gluten al­ler­gy. They plan to file an in­ves­ti­ga­tion­al new drug ap­pli­ca­tion with the FDA by the end of the year.

Anokion spe­cial­izes in au­toim­mune dis­eases and in ad­di­tion to Kan-101, hopes to have its anti­gen-spe­cif­ic mul­ti­ple scle­ro­sis drug, ANK-780, in clin­i­cal de­vel­op­ment with­in the next year. Anokion’s Se­ries B fund­ing will come from Ver­sant Ven­tures, No­var­tis Ven­ture Fund, No­vo Ven­tures and long­time part­ner Cel­gene, along with a hand­ful of Swiss-based pri­vate in­vestors.

Cel­gene re­tains a buy­out op­tion on Anokion from a 2017 agree­ment, al­though that would have to pass muster with Bris­tol-My­ers Squibb as the phar­ma­ceu­ti­cal com­pletes its buy­out of Cel­gene.

No treat­ment cur­rent­ly ex­ists for celi­ac dis­ease, which af­fects 1% of peo­ple. A strict di­et will pre­vent at­tacks, but if even trace amounts of gluten — found in a wide range of foods — slip in, it can ir­ri­tate in­testines and cause long-term health prob­lems.

Anti­gen-spe­cif­ic au­toim­mune ther­a­pies have ap­peared to be the best hope for di­rect­ly treat­ing celi­ac, while biotechs have viewed celi­ac as a way of in­tro­duc­ing plat­forms and ther­a­pies they hope can even­tu­al­ly tar­get oth­er au­toim­mune dis­eases, in­clud­ing MS. These “anti­gen-spe­cif­ic” ther­a­pies try to do what doc­tors have done for over a cen­tu­ry with al­ler­gies: us­ing pro­longed ex­po­sure to in­crease tol­er­ance.  By ex­pos­ing T cells to a par­tic­u­lar anti­gen, the ther­a­py rais­es the cells’ tol­er­ance and damp­en their re­sponse. It just us­es pep­tides in­stead of peanuts.

Promis­ing ther­a­pies, though, have strug­gled. In June, Arch-backed Im­mu­sanT aban­doned a PhII celi­ac tri­al af­ter an in­ter­im analy­sis found lit­tle in­di­ca­tion of suc­cess. They hoped the plat­form could be ap­plied to oth­er au­toim­mune dis­or­ders.

In Au­gust, Ac­to­Bio Ther­a­peu­tics an­nounced it was bring­ing an anti­gen-spe­cif­ic ther­a­py, AG017, in­to the clin­ic. Yes­ter­day, Glax­o­SmithK­line pur­chased one biotech, Sitari, from long­time part­ner Aval­on Ven­tures that takes a dif­fer­ent ap­proach. Sitari us­es a ther­a­py to in­hib­it TG2, which they be­lieve trig­gers the in­flam­ma­to­ry re­sponse in celi­ac dis­ease. They will try to bring the treat­ment in­to the clin­ic for the first time.

Kanyos is al­so work­ing on a di­a­betes ther­a­py.

So­cial im­age: Mi­cro­scop­ic of small in­tes­tine with nor­mal elon­gat­ed vil­li, which in­creas­es sur­face area for ab­sorp­tion of nu­tri­ents. In celi­ac dis­ease, the vil­li are flat, re­sult­ing in di­ar­rhea, Shut­ter­stock

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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