Af­ter painful flop late last year, Al­lakos re­veals new PhI­II da­ta and piv­ots to new in­di­ca­tions

Sev­er­al years af­ter se­cur­ing $100 mil­lion cash in an NEA-led mega round to pur­sue its lead drug in cer­tain al­ler­gic and in­flam­ma­to­ry dis­eases, one-time high fli­er Al­lakos is now piv­ot­ing its R&D ef­forts in the can­di­date to oth­er dis­eases and an­oth­er po­ten­tial can­di­date.

The Cal­i­for­nia-based al­ler­gy and in­flam­ma­tion play­er re­port­ed da­ta from 24 weeks out in the Phase III tri­al EoDyssey, which was in­ves­ti­gat­ing lead drug can­di­date lirente­limab in pa­tients with con­firmed eosinophilic duo­deni­tis — a chron­ic in­flam­ma­to­ry dis­ease char­ac­ter­ized by in­flam­ma­tion in the stom­ach and part of the small in­tes­tine.

Those da­ta came with a hit and a miss. While the tri­al met its his­to­log­ic co-pri­ma­ry end­point, it did not meet the oth­er co-pri­ma­ry end­point, which was pa­tient-re­port­ed symp­to­matic im­prove­ment in both a pre-spec­i­fied pop­u­la­tion and in the “in­tent to treat” pop­u­la­tion.

The pre-spec­i­fied pop­u­la­tion, Al­lakos said, was de­ter­mined off a post-hoc analy­sis of failed Al­lakos Phase III study ENIG­MA2 that read out late last year. Num­bers in the symp­to­matic end­point did not end up be­ing sta­tis­ti­cal­ly sig­nif­i­cant, the biotech added.

In terms of safe­ty, the biotech re­port­ed mild to mod­er­ate in­fu­sion-re­lat­ed re­ac­tions (symp­toms such as flush­ing, feel­ing of warmth, headache, nau­sea and/or dizzi­ness) in 19.6% of pa­tients on lirente­limab and 14.9% of pa­tients on place­bo.

Joseph Thome and Pey­ton Bohn­sack with Cowen were not en­tire­ly sur­prised by the new da­ta, not­ing that this out­come was pret­ty much ex­pect­ed af­ter the failed read­out last year, which al­so missed the symp­to­matic end­point. As the an­a­lysts added Fri­day, “Man­age­ment had al­so pre­vi­ous­ly stat­ed that it ex­pect­ed this out­come in the ITT pop­u­la­tion, as EoDyssey en­rolled a sim­i­lar pop­u­la­tion to the failed ENIG­MA2 tri­al which in­clud­ed pa­tients with po­ten­tial con­found­ing co­mor­bidi­ties.”

Lirente­limab, al­so known as AK002, is an an­ti­body that tar­gets Siglec-8, an in­hibito­ry re­cep­tor part of a fam­i­ly called Sial­ic acid-bind­ing im­munoglob­u­lin-type lectins, aka Siglecs. Al­lakos had been look­ing at Siglecs as part of its ef­forts to in­hib­it mast cells and eosinophils, which play a role in al­ler­gic re­ac­tions and in­flam­ma­tion.

To that end, Al­lakos said it is not plan­ning on do­ing ad­di­tion­al stud­ies in eosinophilic gas­troin­testi­nal dis­eases. How­ev­er, the fu­ture pos­si­bil­i­ty re­mains as the com­pa­ny said it will be work­ing on an­oth­er can­di­date in the mean­time: AK006, al­so known as Siglec-6, that tar­gets an­oth­er in­hibitor in the same fam­i­ly as Siglec-8.

As for lirente­limab, Al­lakos will be mov­ing for­ward on test­ing it in chron­ic spon­ta­neous ur­ticaria — a form of hives — and in atopic der­mati­tis, an in­di­ca­tion that has been the tar­get of many con­tenders and been dom­i­nat­ed by Sanofi/Re­gen­eron’s jug­ger­naut Dupix­ent.

Al­lakos did not re­spond to a re­quest for com­ment from End­points News be­fore pub­li­ca­tion. Shares of $AL­LK were down just shy of 10% when the bell opened af­ter clos­ing Thurs­day at $4.64 a share — a far cry from its high of over $110 a share last year.

The biotech, found­ed in 2012, went pub­lic via a $128 mil­lion IPO in 2018. Just three years lat­er, two sep­a­rate Phase II/III stud­ies across mul­ti­ple types of eosinophilic gas­troin­testi­nal dis­ease showed lirente­limab do­ing close to the ex­act same thing re­port­ed Fri­day — re­duc­ing eosinophil lev­els in the blood but fail­ing to al­le­vi­ate symp­toms. Pa­tients didn’t see any sig­nif­i­cant im­prove­ment over place­bo, to an­a­lyst sur­prise. How­ev­er, an­a­lysts with Jef­feries not­ed at the time that one pos­si­ble cul­prit could have been tri­al de­sign.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”

Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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