Glenn Sblendorio, Iveric Bio CEO

Eye-fo­cused Iver­ic Bio re­ports pos­i­tive PhI­II read­out as shares surge, FDA fil­ing planned

A biotech has claimed a sec­ond Phase III win, and that com­pa­ny is tak­ing its win all the way to the bank — and ul­ti­mate­ly the FDA.

New Jer­sey biotech Iver­ic Bio put out word of its pos­i­tive re­sults Tues­day, say­ing that the com­pa­ny’s drug can­di­date had met the pri­ma­ry end­point of the mean rate of growth (slope) in ge­o­graph­ic at­ro­phy over 12 months. The study en­rolled 448 pa­tients with GA, the most ad­vanced stage of dry AMD, al­so known as age-re­lat­ed mac­u­lar de­gen­er­a­tion.

On ef­fi­ca­cy, the biotech said on a con­fer­ence call Tues­day morn­ing that the drug can­di­date re­duced the mean rate of GA growth by 14.3%, be­ing sta­tis­ti­cal­ly sig­nif­i­cant and se­cur­ing a p-val­ue of p=0.0064. The re­sults are sched­uled to be pre­sent­ed at the end of Sep­tem­ber in Chica­go at the Amer­i­can Acad­e­my of Oph­thal­mol­o­gy’s an­nu­al con­fer­ence.

The drug, called avac­in­cap­tad pe­gol and al­so known as Zimu­ra, is a com­ple­ment C5 pro­tein in­hibitor and the biotech’s lead can­di­date.

Ac­cord­ing to Iver­ic, the most fre­quent­ly re­port­ed oc­u­lar ad­verse events were re­lat­ed to the in­jec­tion pro­ce­dure.

Shares of $ISEE opened up 33% above its clos­ing price of $9.44 on Fri­day and briefly soared to over $15 a share lat­er Tues­day morn­ing, a near 60% in­crease over close.

Iver­ic’s CEO Glenn Sblendo­rio tells End­points News that the com­pa­ny co­or­di­nat­ed with the FDA to use a slope analy­sis on the tri­al, named GATH­ER2. As he not­ed, “For dis­ease that has long-term im­pli­ca­tions, the slope analy­sis gives an in­di­ca­tion of — be­cause you’re plot­ting points on a graph — gives in­di­ca­tion of the po­ten­tial ef­fect be­yond 12 months.” And while the com­pa­ny has da­ta span­ning 18 months, the end­point cen­tered around the com­pa­ny’s NDA fil­ing is on­ly for 12 months.

The biotech, found­ed back in 2007, had re­port­ed pos­i­tive da­ta out of its first Phase III tri­al in Ju­ly 2021. That tri­al had en­rolled 286 par­tic­i­pants.

So far, Iver­ic Bio plans to sub­mit an NDA to the FDA by the end of Q1 next year — and as for in­ter­na­tion­al mar­kets, the com­pa­ny plans to meet with the EMA ear­ly next year and go through its da­ta with reg­u­la­tors there.

To date, there is no ap­proved ther­a­py for dry AMD. How­ev­er, there are oth­er com­pa­nies gun­ning for the reg­u­la­to­ry fin­ish line. Apel­lis se­cured a pri­or­i­ty re­view in GA from the FDA back in Ju­ly for its drug pegc­eta­coplan, mar­ket­ed as Em­paveli for parox­ys­mal noc­tur­nal he­mo­glo­bin­uria. If every­thing goes ac­cord­ing to plan, the FDA has un­til Nov. 26 to de­cide whether or not the drug gets ap­proved in that in­di­ca­tion.

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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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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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.”

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.