Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lil­ly and the NIH are about to start a first-of-its-kind tri­al that re­searchers and de­vel­op­ers have talked about for months as a way of pro­vid­ing tem­po­rary im­mu­ni­ty to the most at-risk pop­u­la­tions.

Lil­ly an­nounced this morn­ing that it will start a 2,400-per­son tri­al with the Na­tion­al In­sti­tute for Al­ler­gy and In­fec­tious Dis­eases to test whether its ex­per­i­men­tal Covid-19 neu­tral­iz­ing an­ti­body can pre­vent peo­ple in nurs­ing homes and as­sist­ed liv­ing fa­cil­i­ties from de­vel­op­ing the dis­ease. The idea, known as pas­sive im­mu­ni­ty, is that rather than wait­ing on a vac­cine to in­duce peo­ple to de­vel­op an­ti­bod­ies, doc­tors can give them lab-grown an­ti­bod­ies. Ide­al­ly, those an­ti­bod­ies will ei­ther at­tack the new SARS-CoV-2 in­fec­tion, if the pa­tient has re­cent­ly been ex­posed, or per­sist in the blood for sev­er­al weeks and pre­vent in­fec­tion or dis­ease for that pe­ri­od.

The ap­proach is con­sid­ered par­tic­u­lar­ly use­ful in the el­der­ly, who are both at an el­e­vat­ed risk of dy­ing from Covid-19 and are less like­ly to re­spond to a vac­cine. Re­gen­eron has launched a sim­i­lar tri­al in part­ner­ship with NI­AID, test­ing their an­ti­body in peo­ple who have like­ly been ex­posed as close con­tacts of Covid-19 pa­tients. Vir has plans to start their own pro­phy­lax­is tri­al this month.

Lil­ly’s Phase III tri­al will mea­sure whether a sin­gle dose of the an­ti­body, de­vel­oped with the Van­cou­ver biotech Ab­Cellera and known as LY-COV555, can pre­vent SARS-CoV-2 in­fec­tion for 4 weeks and Covid-19 symp­toms for 8 weeks.

To con­duct the tri­al, Lil­ly has retro­fit­ted RVs in­to “cus­tomized mo­bile re­search units” that will al­low in­ves­ti­ga­tors to pre­pare clin­i­cal tri­al ma­te­r­i­al and in­fuse pa­tients with the an­ti­body on-site.

Take­da, Am­gen, Ab­b­Vie team on Covid-19 tri­al 

Take­da, Am­gen and Ab­b­Vie an­nounced they will team up on a tri­al to see whether a drug from each com­pa­ny can be re­pur­posed to help treat pa­tients with se­vere Covid-19.

The tri­al, known as I-SPY COVID, will test Take­da’s in­ves­ti­ga­tion­al chemokine an­tag­o­nist Fi­razyr, Am­gen’s block­buster PDE4 in­hibitor Ote­zla, and Ab­b­Vie’s an­gioede­ma drug ceni­crivi­roc. The study will use an adap­tive tri­al de­sign to test each of the drugs in com­bi­na­tion with the two drugs proven to help Covid-19 pa­tients — the Gilead an­tivi­ral remde­sivir and the gener­ic steroid dex­am­etha­sone — against a com­bi­na­tion of just remde­sivir and dex­am­etha­sone.

The study is one of the first vis­i­ble re­sults to come out the Covid R&D Al­liance, a group formed in April to pool re­sources and in­sight from some of the top phar­mas and biotechs and pri­or­i­tize the best ther­a­pies. The al­liance says it has al­so screened over 1,900 oth­er pre­clin­i­cal Covid-19 can­di­dates and helped speed the de­vel­op­ment of nov­el ther­a­peu­tics.

Each of the three drugs have dif­fer­ent mech­a­nisms of ac­tion that could mit­i­gate symp­toms in se­vere Covid-19 pa­tients. Ote­zla could com­bat the over­ac­tive in­flam­ma­to­ry re­sponse and Fi­razyr might lim­it flu­id buildup in lungs. Ceni­crivi­roc, by block­ing cer­tain im­mune sig­nal, might mit­i­gate acute res­pi­ra­to­ry dis­tress.

Drug re­pur­pos­ing has been tried since Covid-19’s ear­ly days, with lim­it­ed suc­cess. IL-6 in­hibitors from Re­gen­eron and Roche have failed, as have a se­ries of HIV drugs. The NIH is cur­rent­ly test­ing Eli Lil­ly’s JAK in­hibitor baric­i­tinib in com­bi­na­tion with remde­sivir to see if it can im­prove symp­toms in se­vere pa­tients.

Neu­roRx, Re­lief Ther­a­peu­tics launch Phase II/III tout re­port of a sin­gle pa­tient

Re­lief Ther­a­peu­tics and Neu­roRx have launched a Phase II/III tri­al and ex­pand­ed ac­cess pro­to­col for their vas­cu­lar pep­tide avip­tadil in pa­tients with Covid-19. The drug had been in de­vel­op­ment for pul­monary sar­coido­sis and pul­monary hy­per­ten­sion be­fore the com­pa­nies start­ed test­ing it in Covid-19 pa­tients, with the idea that it could block pro-in­flam­ma­to­ry cy­tokines and pro­tect cer­tain lung cells from in­fec­tion.  The com­pa­nies have tout­ed the re­port of a sin­gle pa­tient with se­vere Covid-19 who, giv­en the drug un­der ex­pand­ed ac­cess, re­cov­ered in 4 days. Neu­roRx CEO Jonathan Javitt was an au­thor on that pre-print re­port.

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

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.