Covid-19 roundup: NIH spot­lights blood thin­ners in its next big tri­al; All it took was a pan­dem­ic to get JPM out of SF

Af­ter im­mune mod­u­la­tors and an­ti­bod­ies, blood thin­ners are the next class of drugs to be put through a Phase III tri­al or­ga­nized un­der the NIH’s AC­TIV ini­tia­tive.

Three dif­fer­ent an­ti­co­ag­u­lants have been named for the mas­ter pro­to­col: he­parin, as­pirin and apix­a­ban. In­formed by stud­ies sug­gest­ing that many pa­tients who died from Covid-19 have formed un­usu­al blood clots through­out their bod­ies — in­clud­ing in their small­est blood ves­sels — the NIH wants to see which ther­a­pies are the most ef­fec­tive at pre­vent­ing or re­duc­ing them and thus im­prov­ing out­comes for pa­tients.

Fran­cis Collins NIH

“There is cur­rent­ly no stan­dard of care for an­ti­co­ag­u­la­tion in hos­pi­tal­ized COVID-19 pa­tients, and there is a des­per­ate need for clin­i­cal ev­i­dence to guide prac­tice,” agency head Fran­cis Collins said in a state­ment. “Con­duct­ing tri­als us­ing mul­ti­ple ex­ist­ing net­works of re­search sites pro­vides the scale and speed that will get us an­swers faster.”

For the in­pa­tient tri­al, pa­tients will be giv­en ei­ther a low dose or a high dose of he­parin.

But hos­pi­tal­ized pa­tients are just one of two groups now be­ing re­cruit­ed to AC­TIV-4, which al­so in­cludes an out­pa­tient tri­al — bro­ken down in­to four co­horts giv­en place­bo, as­pirin, or a low or ther­a­peu­tic dose of the blood thin­ner apix­a­ban. The goal there is to re­duce life-threat­en­ing car­dio­vas­cu­lar or pul­monary com­pli­ca­tions in new­ly-di­ag­nosed Covid-19 pa­tients who don’t need hos­pi­tal ad­mis­sion.

Gary Gib­bons

Gary Gib­bons, di­rec­tor of the Na­tion­al Heart, Lung, and Blood In­sti­tute, said while he­parin has shown promise, physi­cians “re­al­ly need clin­i­cal tri­al da­ta to de­ter­mine how much blood thin­ner, or even an­ti-platelet med­ica­tion, to give.”

A third tri­al will start soon in­volv­ing pa­tients who had mod­er­ate or se­vere dis­ease but have been dis­charged af­ter hos­pi­tal­iza­tion. It has a slight­ly dif­fer­ent de­sign, with the key met­ric be­ing whether pa­tients de­vel­op throm­bot­ic com­pli­ca­tions (think heart at­tack, stroke, blood clots in ma­jor veins or ar­ter­ies and death) with­in 45 days of be­ing hos­pi­tal­ized.

As is cus­tom in these mas­ter pro­to­cols, re­searchers may switch out can­di­dates or add in new ther­a­pies as clin­i­cal da­ta emerge.

NHLBI is co­or­di­nat­ing and over­see­ing the pro­gram, while Op­er­a­tion Warp Speed is pro­vid­ing the fund­ing. — Am­ber Tong

#JPM21 goes vir­tu­al

The JP Mor­gan Health­care Con­fer­ence just got a whole lot cheap­er.

On Thurs­day, the bank told clients that the famed con­fer­ence was go­ing vir­tu­al. That means no more pack­ing in­to ball­rooms and con­fer­ence halls, no more dash­ing be­tween dif­fer­ent ho­tel rooms for an end­less cir­cle of meet­ings, and cru­cial­ly no more $2,000 suites and $150 rent-a-ta­bles. In­stead, there will on­ly be what there has been for the last 6 months: End­less cir­cles of Zoom meet­ings, looped in in­fi­nite re­cur­sion from San Diego to Boston to Cam­bridge, UK.

The vir­tu­al con­fer­ence means that, af­ter years of chat­ter, the con­fer­ence will fi­nal­ly, at least for a year, leave San Fran­cis­co. In the­o­ry, though, you could still go. A room at the West­in is sell­ing for on­ly $276, break­fast not in­clud­ed. — Ja­son Mast

Would you take a vac­cine be­fore No­vem­ber 3?

Long­time FDA of­fi­cials and drug com­pa­nies are try­ing to shore up pub­lic con­fi­dence in an even­tu­al Covid-19 vac­cine, but a new poll sug­gests that, at least un­til the elec­tion, they could be fac­ing an up­hill bat­tle.

The poll, con­duct­ed by the Kaiser Fam­i­ly Foun­da­tion, found that most adults, both Re­pub­li­can and De­mo­c­rat, are wary of tak­ing a vac­cine be­fore the elec­tion. Six in ten adults, mean­while, were wor­ried that the Trump Ad­min­is­tra­tion would pres­sure the FDA to rush an ap­proval. The poll was con­duct­ed be­tween Au­gust 28 and Sep­tem­ber 3 — days af­ter a heav­i­ly politi­cized emer­gency use au­tho­riza­tion for con­va­les­cent plas­ma stoked fears that a vac­cine would be au­tho­rized un­der sim­i­lar con­di­tions.

Fear of po­lit­i­cal pres­sure was most acute among De­moc­rats, 51% of whom said they were “very wor­ried” and 85% of whom were at least “some­what wor­ried.” A ma­jor­i­ty of Re­pub­li­cans said they were “not too wor­ried” or “not at all wor­ried,” al­though 35% ex­pressed some con­cern.

As to whether they would take a vac­cine, though, the splits are re­versed. Half of De­moc­rats were will­ing to take a vac­cine, but on­ly 36% of Re­pub­li­cans said they would. These num­bers are in line with long-run­ning dif­fer­ences be­tween De­moc­rats and Re­pub­li­cans on vac­ci­na­tion, though it does sug­gest that re­cent events may have dent­ed views. A Gallup poll con­duct­ed in late Ju­ly and ear­ly Au­gust found 81% of De­moc­rats and 47% of Re­pub­li­cans were will­ing to take an “an FDA-ap­proved vac­cine to pre­vent coro­n­avirus/COVID-19” if it “was avail­able right now at no cost.” Those ques­tions, though, did not di­rect­ly ref­er­ence the elec­tion.

Still, most re­spon­dents did not think such an even­tu­al­i­ty was like­ly. Eighty-one per­cent of peo­ple, re­gard­less of par­ty, did not ex­pect a vac­cine to come be­fore No­vem­ber 3.

The polls come as of­fi­cials in the US strug­gle to shore up con­fi­dence in any even­tu­al­ly ap­proved vac­cine. Ear­li­er this week, 9 ma­jor drug com­pa­nies signed a pledge to on­ly sub­mit vac­cine da­ta when it meets safe­ty and ef­fi­ca­cy stan­dards and 8 FDA ca­reer of­fi­cials pub­lished an open let­ter in USA To­day on their com­mit­ment to sci­ence. Even be­fore the lat­est con­cerns of po­lit­i­cal in­ter­fer­ence, pub­lic health ex­perts have talked for months about how ris­ing rates of vac­cine hes­i­tan­cy could pose a bar­ri­er in pan­dem­ic re­sponse. Bill Gates has called get­ting peo­ple to ac­tu­al­ly take a vac­cine “the fi­nal hur­dle.”

New da­ta high­light how crit­i­cal mes­sag­ing can be on vac­cine up­take. A large study pub­lished this morn­ing in The Lancet tracked glob­al vac­cine hes­i­tan­cy from 2015 to 2019 iden­ti­fied mis­in­for­ma­tion as one of the key fac­tors in places with grow­ing skep­ti­cism of vac­cines, in­clud­ing South Ko­rea, Malaysia, and Geor­gia. An­thro­pol­o­gist and di­rec­tor of the Vac­cine Con­fi­dence Pro­ject Hei­di Lar­son, the study’s au­thor, said mes­sag­ing in the US and else­where that fo­cused on speed wasn’t help­ing.

“There’s a lot of anx­i­ety about the speed of vac­cine de­vel­op­ment (for COVID-19),” she told Reuters. “But the pub­lic is not re­al­ly keen on speed – they’re more keen on thor­ough­ness, ef­fec­tive­ness and safe­ty.” — Ja­son Mast

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.