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

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

David Grainger [file photo]

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Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

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It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

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We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.