L-R: CDC director Robert Redfield, NIAID director Anthony Fauci, HHS assistant secretary for health Brett Giroir and FDA commissioner Stephen Hahn testify before Congress, June 23, 2020 (Kevin Dietsch, Pool via AP Images)

Covid-19 roundup: An­tho­ny Fau­ci, Stephen Hahn tes­ti­fy in Con­gress; Chi­na's Sinopharm speeds in­to PhI­II vac­cine tri­al

In the ear­ly days of the out­break, NI­AID-chief-turned-Amer­i­ca’s-Doc­tor An­tho­ny Fau­ci cau­tioned Amer­i­cans that a vac­cine could come in 12-18 months. Af­ter sev­er­al months of re­search and de­vel­op­ment and hun­dreds of vac­cine projects around the globe, he’s stick­ing with the most op­ti­mistic end of that as­s­es­ment.

Ap­pear­ing in a black cloth mask be­fore the House En­er­gy and Com­merce Com­mit­tee, Fau­ci ex­pressed con­fi­dence about the ar­rival of a vac­cine even as he of­fered a sober as­sess­ment of the “dis­turb­ing surge” of in­fec­tions now tak­ing off in some parts of the coun­try.

“You re­mem­ber, I told your com­mit­tee a few months ago, that a vac­cine would be avail­able from a year to 18 months,” he said in a re­sponse to a ques­tion from Di­ana DeGette (D-CO). “I said that in Jan­u­ary of 2020. A year from Jan­u­ary is De­cem­ber. I still think there is a rea­son­ably good chance that by the very be­gin­ning of 2021, that — if we’re go­ing to have a vac­cine — that we will have it by then.”

For a lit­tle over 2 hours, Fau­ci an­swered ques­tions along­side CDC di­rec­tor Robert Red­field, FDA di­rec­tor Stephen Hahn and HHS as­sis­tant sec­re­tary for health Brett Giroir. He ex­plained ad­ju­vants, the first large-scale tri­als set to be­gin this sum­mer, and how the gov­ern­ment and in­dus­try were scal­ing up pro­duc­tion at-risk so they’ll be ready if one proves ef­fec­tive. He bat­ted down the idea that mu­ta­tions in the virus might make a vac­cine in­ef­fec­tive — an as­ser­tion not yet borne out by da­ta on the thou­sands of se­quenced coro­n­avirus genomes.

“Well, we al­ready know it’s mu­tat­ed, right?” Kurt Schrad­er (D-OR) said, af­ter Fau­ci said the flu vac­cine is of­ten in­ef­fec­tive be­cause of in­fluen­za virus changes.

“Yeah,” said Fau­ci. “That doesn’t make any dif­fer­ence. All RNA virus­es mu­tate. That doesn’t mean they change.”

Hahn, mean­while, faced a litany of ques­tions on how the FDA would eval­u­ate a vac­cine. The agency has faced scruti­ny for its ac­tions dur­ing the out­break par­tic­u­lar­ly af­ter it au­tho­rized the Trump-tout­ed an­ti-malar­ia drug hy­drox­y­chloro­quine, de­spite a pauci­ty of ev­i­dence for the ef­fec­tive­ness.

“Let me be clear,” he said. “The da­ta and sci­ence will dic­tate when we will have safe and ef­fec­tive treat­ments and vac­cines for Covid-19.”

“The ac­cel­er­a­tion is re­al­ly around tak­ing fi­nan­cial risk round the de­vel­op­men­tal process; the ac­cel­er­a­tion is not cut­ting cor­ners with re­spect to the as­sess­ment of safe­ty and ef­fec­tive­ness,” he added when pressed by Fred Up­ton (R-MI). “We’ve been do­ing this for years, and we will re­ly up­on the sci­ence and da­ta when it’s avail­able to us, to make that ad­ju­di­ca­tion and de­ci­sion re­gard­ing an EUA. I can­not pre­judge when that will hap­pen.” — Ja­son Mast

Unit­ed Arab Emi­rates hosts PhI­II tri­al for vac­cine can­di­date from Chi­na’s Sinopharm

Leapfrog­ging both do­mes­tic and over­seas ri­vals, Chi­na’s Sinopharm has start­ed a Phase III tri­al for one of its in­ac­ti­vat­ed vac­cine can­di­dates against Covid-19 in the Unit­ed Arab Emi­rates.

That the study of a home­grown vac­cine is tak­ing place out­side Chi­na high­lights the bizarre prob­lem re­searchers can en­counter when a coun­try brings its lo­cal out­break (even the sec­ond waves) un­der con­trol. If the dis­ease isn’t preva­lent enough in a giv­en re­gion, it may be near im­pos­si­ble to tease out the re­al ef­fects of an im­mu­niza­tion com­pared to place­bo.

Sinopharm is work­ing with lo­cal part­ners for both da­ta an­a­lyt­ics and man­u­fac­tur­ing, in­clud­ing Abu Dhabi-based AI and cloud com­put­ing com­pa­ny Group 42.

The vac­cine be­ing test­ed is made by the Wuhan In­sti­tute of Bi­o­log­i­cal Prod­ucts, one of its mul­ti­ple sub­sidiaries, and has com­plet­ed Phase I/II tri­als in Henan province. A sim­i­lar ex­per­i­men­tal vac­cine de­vel­oped by the Bei­jing In­sti­tute of Bi­o­log­i­cal Prod­ucts is still in the ear­li­er phase.

A state-owned en­ter­prise, Sinopharm en­list­ed its own work­ers to help de­ter­mine the safe­ty and ef­fi­ca­cy of the vac­cines in de­vel­op­ment, ul­ti­mate­ly ad­min­is­ter­ing them to more than 1,000 em­ploy­ees. It’s al­so of­fered jabs to staffers of oth­er state-owned en­ter­pris­es trav­el­ling over­seas.

Spe­cial­ized man­u­fac­tur­ing fa­cil­i­ties are re­quired to pro­duce in­ac­ti­vat­ed vac­cines since the pro­duc­ers must first bring in the live virus in or­der to “kill” them, ei­ther with heat or chem­i­cals. Sinopharm has dis­closed that it has ca­pac­i­ty to make 120 mil­lion dos­es in Bei­jing and an­oth­er 100 mil­lion in Wuhan — al­though it’s not yet clear how many shots each per­son will need. — Am­ber Tong

As­traZeneca turns to Scot­land for lat­est vac­cine sup­ply deal

Scot­land’s Sym­bio­sis Phar­ma­ceu­ti­cal is the lat­est part­ner on As­traZeneca’s ros­ter for churn­ing out 2 bil­lion dos­es of the Ox­ford vac­cine by the end of 2021.

By Reuterscount, this marks the 10th Covid-19 vac­cine sup­ply deal from the phar­ma gi­ant, which had signed on less than two months ago to scale up the glob­al de­vel­op­ment, man­u­fac­tur­ing and dis­tri­b­u­tion of the chim­panzee ade­n­ovirus-based vac­cine can­di­date orig­i­nat­ing from the Jen­ner In­sti­tute.

The new part­ners didn’t spec­i­fy how many dos­es Sym­bio­sis has com­mit­ted to pro­duc­ing, not­ing on­ly that its head­quar­ters in Stir­ling is staffed with 100 pro­fes­sion­als.

With Phase III tri­als un­der­way in the UK and Brazil, As­traZeneca had mapped out plans to launch with help from Op­er­a­tion Warp Speed. — Am­ber Tong

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

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.