Tillman Gerngross, Adagio CEO

Ada­gio of­fers first peek at Covid-19 an­ti­body da­ta, with pre­ven­ta­tive num­bers that may ri­val mR­NA vac­cines

Till­man Gern­gross cer­tain­ly wasn’t the first to tack­le Covid-19 an­ti­bod­ies, but he has rea­son to be­lieve he and his team at Ada­gio could be the best. Now, we’re get­ting a first peek at hu­man pre­ven­ta­tive da­ta for Ada­gio’s lead an­ti­body, and it looks up to par with the best of the vac­cines.

Now, Ada­gio is churn­ing out ear­ly da­ta from that Phase I test show­ing a sin­gle dose of an­ti­body ADG20 of­fered broad­ly neu­tral­iz­ing ac­tiv­i­ty in healthy vol­un­teers com­pa­ra­ble to peak titers re­port­ed from the mR­NA vac­cines and could of­fer pro­tec­tion for up to 12 months, the biotech said Wednes­day. There were no hard num­bers im­me­di­ate­ly avail­able.

Based on those find­ings, Ada­gio has launched its glob­al Phase II/III EVADE study that will test ADG20 in both the pre- and post-ex­po­sure set­tings at 100 sites. The study will eval­u­ate an ini­tial 200 adults in Phase II be­fore po­ten­tial­ly open­ing en­roll­ment to ado­les­cents and preg­nant women in Phase III. The pri­ma­ry ef­fi­ca­cy end­point in both co­horts is the pre­ven­tion of lab­o­ra­to­ry con­firmed, symp­to­matic Covid-19, Ada­gio said.

Lynn Con­nol­ly

“Based on its po­tent and broad ac­tiv­i­ty and ex­tend­ed du­ra­tion of ef­fect in pre­clin­i­cal mod­els, we be­lieve that ADG20 has the po­ten­tial to pro­vide both rapid pro­tec­tion in the face of a known, re­cent ex­po­sure to an in­di­vid­ual with SARS-CoV-2 in­fec­tion as well as durable pro­tec­tion over sev­er­al months, in­clud­ing for in­di­vid­u­als who are un­like­ly to have a suf­fi­cient­ly pro­tec­tive im­mune re­sponse to vac­cines,” CMO Lynn Con­nol­ly said in a state­ment.

Based on sci­ence from Gern­gross and his team at Adimab, Ada­gio has made a late push to bring a bet­ter Covid-19 an­ti­body to mar­ket af­ter some mixed re­sults from drug­mak­ers who raced oth­er can­di­dates to mar­ket and have seen lim­it­ed ef­fi­ca­cy against vari­ants.

In April, Ada­gio snared $336 mil­lion as part of a Se­ries C round led by RA Cap­i­tal to ad­vance ADG20 through a piv­otal Phase I/II/III tri­al for the treat­ment of high-risk, mild to mod­er­ate Covid-19 pa­tients. That tri­al, dubbed STAMP, stands apart from the pre­ven­ta­tive study Ada­gio read out Thurs­day.

The com­pa­ny be­lieves its an­ti­bod­ies have broad­ly neu­tral­iz­ing po­ten­tial against the SARS-CoV-2 emerg­ing vari­ants as well as oth­er sar­be­covirus­es apart from the nov­el coro­n­avirus, Ada­gio said. That could mean some stay­ing pow­er post-Covid.

STAMP is de­signed to rapid­ly turn out proof-of-con­cept da­ta that could form the ba­sis for an emer­gency use au­tho­riza­tion fil­ing, Ada­gio said.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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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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.”

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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