David Hering, Adagio interim CEO

Ada­gio press­es for­ward with their FDA pitch for Covid an­ti­body — de­spite Omi­cron flaws

Ada­gio, the Till­man Gern­gross biotech whose $750 mil­lion plan to build a pan-coro­n­avirus an­ti­body seem­ing­ly fell apart in the face of Omi­cron, is back again plead­ing its case.

The com­pa­ny re­leased da­ta from its piv­otal tri­als Wednes­day, an­nounc­ing that its an­ti­body ad­in­tre­vimab re­duced the risk of hos­pi­tal­iza­tion or death in par­tic­i­pants with mild to mod­er­ate Covid-19 by 66%, in­clud­ing a 77% re­duc­tion in pa­tients who were treat­ed with­in 3 days of symp­tom on­set.

The drug al­so worked as pre-ex­po­sure and post-ex­po­sure pro­phy­lax­is, re­duc­ing the risk of vol­un­teers de­vel­op­ing symp­to­matic Covid-19 by 71% and 75% re­spec­tive­ly.

The prob­lem is that near­ly all of the da­ta for the study were col­lect­ed pri­or to the ad­vent of Omi­cron, a vari­ant that Ada­gio’s own da­ta showed re­duced the po­ten­cy of their an­ti­body 300 times, forc­ing the com­pa­ny to pur­sue al­ter­na­tive strate­gies such as chang­ing dose and com­bi­na­tion treat­ments.

De­spite the set­backs, the biotech con­tin­ued to in­sist that the an­ti­body was al­ready so po­tent that it might have ef­fi­ca­cy against Omi­cron, even if it was re­duced. Lim­it­ed da­ta col­lect­ed in the tri­als at­test­ed to that. For ex­am­ple, pa­tients who re­ceived pro­phy­lac­tic ad­in­tre­vimab were still 47% less like­ly to de­vel­op symp­to­matic dis­ease with­in 77 days fol­low­ing the emer­gence of Omi­cron. (Ada­gio did not spec­i­fy when they be­gan the analy­sis or how wide­spread Omi­cron was at the time.)

But the US is no longer deal­ing sole­ly with Omi­cron. Omi­cron’s “sis­ter vari­ant,” BA.2, is now caus­ing a ma­jor­i­ty of new cas­es na­tion­wide, ac­cord­ing to CDC da­ta.

And Ada­gio’s drug has vir­tu­al­ly ze­ro ac­tiv­i­ty against BA.2, analy­ses from out­side labs have demon­strat­ed.

Nev­er­the­less, the com­pa­ny is go­ing to press its case at the FDA, with plans to sub­mit an ap­pli­ca­tion for emer­gency use au­tho­riza­tion in Q2. The com­pa­ny’s state­ment did not ad­dress the drug’s dra­mat­i­cal­ly re­duced ef­fi­ca­cy against BA.2.

Ada­gio al­so said it’s con­tin­u­ing with tri­als on a high­er dose of ad­in­tre­vimab while de­vel­op­ing new an­ti­bod­ies from its li­brary and at­tempt­ing to re-en­gi­neer ad­in­tre­vimab to have im­proved bind­ing against the new vari­ants.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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