Re­searchers shut­ter 2 Covid-19 stud­ies as mon­i­tors flag Eli Lil­ly an­ti­bod­ies as a flop for pneu­mo­nia, hos­pi­tal­ized pa­tients — but EUA hunt con­tin­ues

Two weeks af­ter the safe­ty da­ta mon­i­tor­ing group ad­vised re­searchers to hit the hold but­ton on a clin­i­cal tri­al of Eli Lil­ly’s an­ti­body bam­lanivimab (LY­CoV55) for pa­tients hos­pi­tal­ized with Covid-19, the tri­al over­seers are back with fresh di­rec­tions to shut­ter the study af­ter los­ing faith that the drug could help this group of pa­tients.

The mon­i­tors con­clud­ed, how­ev­er, that there were no safe­ty is­sues in­volved, which will like­ly en­cour­age con­tin­ued be­lief that Lil­ly can still nail down an emer­gency mar­ket­ing ap­pli­ca­tion for less-sick pa­tients.

On Tues­day morn­ing, Lil­ly fol­lowed up with more bad news about their cost­ly Covid-19 ef­forts, which hit their top-line num­bers for Q3. A Phase II study for LY3127804, an ex­per­i­men­tal an­ti­body tar­get­ing An­giopoi­etin 2, was dropped from the pipeline, with­out ex­pla­na­tion. The move to yank the study was not­ed in their chart on the up­dat­ed pipeline.

Re­searchers were study­ing the drug for pneu­mo­nia pa­tients hos­pi­tal­ized with COVID-19 on the the­o­ry that in­hibit­ing Ang2 would re­duce the need for ven­ti­la­tion. In re­sponse to a query, a Lil­ly spokesper­son told me the pro­gram was halt­ed in Sep­tem­ber due to fu­til­i­ty. There were no safe­ty is­sues in­volved.

Lil­ly’s shares were down more than 5% Tues­day, ahead of the bell.

In a state­ment on the bam­lanivimab move, Lil­ly not­ed:

Based on an up­dat­ed dataset from the tri­al re­viewed on Oc­to­ber 26, no ad­di­tion­al COVID-19 pa­tients in this hos­pi­tal­ized set­ting will re­ceive bam­lanivimab. This rec­om­men­da­tion was based on tri­al da­ta sug­gest­ing that bam­lanivimab is un­like­ly to help hos­pi­tal­ized COVID-19 pa­tients re­cov­er from this ad­vanced stage of their dis­ease. In this up­dat­ed dataset, dif­fer­ences in safe­ty out­comes be­tween the groups were not sig­nif­i­cant.

The orig­i­nal halt to the study — part of a mas­ter pro­to­col ef­fort dubbed AC­TIV-3 run by the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases that com­bined the an­ti­body with Gilead’s remde­sivir — came about af­ter one group in the study ap­peared to do bet­ter than an­oth­er, though the com­pa­ny nev­er iden­ti­fied which group.

Now, Lil­ly says that while the monother­a­py added to oth­er drugs doesn’t ap­pear to help hos­pi­tal­ized pa­tients, they say they “re­main con­fi­dent based on da­ta from Lil­ly’s BLAZE-1 study that bam­lanivimab monother­a­py may pre­vent pro­gres­sion of dis­ease for those ear­li­er in the course of COVID-19.”

Da­ta from that BLAZE-1 Phase II study are be­ing used to back Lil­ly’s ap­pli­ca­tion for an emer­gency use au­tho­riza­tion. And Pres­i­dent Trump has al­ready tout­ed the drug as a ver­i­ta­ble cure.

There are sev­er­al on­go­ing stud­ies, in­clud­ing BLAZE-1. The oth­er 2:

— AC­TIV-2, the NIH-spon­sored study in re­cent­ly di­ag­nosed mild to mod­er­ate Covid-19 pa­tients.

— BLAZE-2, Lil­ly’s Phase III study of bam­lanivimab for the pre­ven­tion of Covid-19 in res­i­dents and staff at long-term care fa­cil­i­ties.

The tri­al da­ta for the first round of drugs aimed at Covid-19 have of­fered a mixed batch of pos­i­tive and neg­a­tive re­sults.

Gilead was the first to get an EUA for remde­sivir, and the first to get full ap­proval. But it al­so won the OK af­ter a WHO study con­clud­ed that the drug did not im­prove mor­tal­i­ty rates.

Lil­ly has had to con­tend with oth­er set­backs as well, in­clud­ing re­ports that the man­u­fac­tur­ing fa­cil­i­ty that makes its an­ti­body was cit­ed for se­ri­ous qual­i­ty con­trol con­cerns. The an­ti­body bam­lanivimab was de­vel­oped orig­i­nal­ly by Ab­Cellera and then part­nered with Lil­ly.

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

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

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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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image:

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.