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

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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