WHO ACT-Ac­cel­er­a­tor pri­or­i­tizes glob­al vac­cine ap­proach

The im­por­tance of a glob­al ap­proach to vac­cine de­vel­op­ment and pro­duc­tion, with a fo­cus on col­lab­o­ra­tion, was a top­ic of a tech­ni­cal up­date and press brief­ing held 26 June by the WHO.

Soumya Swami­nathan

The usu­al prac­tices for drug de­vel­op­ment have been up­end­ed by the speed and scale of the Covid-19 pan­dem­ic, said of­fi­cials. “I’m very hope­ful and op­ti­mistic that this will be an un­prece­dent­ed col­lab­o­ra­tion that al­so sets a mod­el for the fu­ture,” said WHO Chief Sci­en­tif­ic Of­fi­cer Soumya Swami­nathan, MD, speak­ing in an up­date on WHO’s col­lab­o­ra­tive Ac­cess to COVID Tools (ACT) Ac­cel­er­a­tor project. “Com­pa­nies that are tra­di­tion­al­ly ri­vals are shar­ing” re­search pro­to­cols and oth­er da­ta and process­es usu­al­ly held as con­fi­den­tial com­mer­cial in­for­ma­tion, said Swami­nathan.

In re­sponse to ques­tion­ing from jour­nal­ists, Swami­nathan ac­knowl­edged that As­tra Zeneca may have the “lead­ing can­di­date” in the race to a vac­cine. “The Mod­er­na vac­cine is not too far be­hind,” she said, adding that “As­tra Zeneca has a more glob­al scope in terms of where they are plan­ning their vac­cine tri­als; there is an ad­van­tage for com­pa­nies” who can plan for mul­ti­ple tri­al sites in a va­ri­ety of glob­al set­tings.

An­drew Wit­ty

Added An­drew Wit­ty, the WHO Di­rec­tor-Gen­er­al Spe­cial En­voy for the ACT Ac­cel­er­a­tor, “We have seen a tremen­dous amount of ef­fort on a va­ri­ety of vac­cines… A va­ri­ety of dif­fer­ent tech­niques are be­ing em­ployed with a va­ri­ety of sci­en­tif­ic tar­gets,” so as­sess­ing which vac­cine is re­al­ly the front-run­ner might not be so straight­for­ward. “At this very ear­ly stage it’s im­por­tant to re­main quite hum­ble; un­til we start to see suc­cess this is in a very ex­per­i­men­tal phase.”

The di­ver­si­fied port­fo­lio of vac­cines re­search in­creas­es the chances of find­ing suc­cess on a prac­ti­cal as well as a sci­en­tif­ic lev­el, added Wit­ty. “Glob­al­ly, di­verse and sig­nif­i­cant con­ri­bu­tions are be­ing made by large phar­ma­ceu­ti­cal com­pa­nies…but we’ve got very ac­tive re­search pro­grams in Chi­na.” Wit­ty not­ed that In­dia al­so has ac­tive vac­cine re­search un­der­way.

Said Wit­ty, “It’s still very ear­ly days in this jour­ney. We could be su­per-lucky – which would be ter­rif­ic – and have an ear­ly win.” Re­gard­less, he said, “This is with­out prece­dent the world’s fastest de­vel­op­ment of a vac­cine.”

Bruce Ayl­ward

Bruce Ayl­ward, MD, the se­nior ad­vi­sor to WHO’s Di­rec­tor-Gen­er­al on Or­ga­ni­za­tion­al Change, added that not all vac­cine de­vel­op­ment ef­forts may be on the radar of those track­ing the ini­tia­tives. “There are a num­ber of dif­fer­ent plat­forms on which the vac­cines are be­ing pro­duced … The oth­er thing we need to be care­ful about is that there may be lots of oth­ers we may not be aware of,” if the vac­cines are not be­ing de­vel­oped un­der pub­lic con­tracts.

WHO is cur­rent­ly in the process of sign­ing con­fi­den­tial­i­ty agree­ments to re­view dossiers, pro­vide ad­vice and sup­port, and fa­cil­i­tate clin­i­cal tri­al ac­tiv­i­ty for Chi­nese vac­cine man­u­fac­tur­ers, in­clud­ing Sino­vac, CanSi­no, and the Bei­jing In­sti­tute of Vi­ral Tech­nol­o­gy, said Swami­nathan. The goal is to make sure tri­als get the de­tails right, achiev­ing “the right set­tings, the right size, the right end­points.”

She added that Chi­nese man­u­fac­tur­ers, along with In­di­an de­vel­op­ers “are a lit­tle be­hind – but there are a lot of good ef­forts go­ing on.” In par­tic­u­lar, she called out In­di­an man­u­fac­tur­ers as ex­plor­ing “a lot of in­no­v­a­tive vac­cine de­vel­op­ment pro­grams,” not­ing al­so that Brazil and Nige­ria are work­ing on their own pro­grams as well. “The more shots we have [at a suc­cess­ful vac­cine] the bet­ter,” she said. “This is a virus we didn’t know much about 6 to 9 months ago, but we are learn­ing more about it every day.”

When it comes to de­vel­op­ment and dis­tri­b­u­tion of vac­cines and ther­a­peu­tics, WHO plans to use an “all-coun­tries ap­proach,” said Mar­i­an­gela Simao, MD, WHO’s As­sis­tant Di­rec­tor-Gen­er­al for Ac­cess to Med­i­cines, Vac­cines and Phar­ma­ceu­ti­cals. From the WHO per­spec­tive, a trans­par­ent process of se­lec­tion and al­lo­ca­tion of vac­cine re­cip­i­ents that is dri­ven by pub­lic health needs is para­mount, she said. WHO ex­pects to have an al­lo­ca­tion mech­a­nism to share with the pub­lic by the end of Au­gust.

“We are fo­cus­ing on vac­cines first. It will take some time to ramp up pro­duc­tion of safe and ef­fec­tive prod­ucts,” and de­tails down to the minu­ti­ae of cold-chain re­quire­ments will need to be sort­ed out at the coun­try and lo­cal lev­el, she said. In the past, “weak­er sup­ply chains at the coun­try lev­el have de­layed in­tro­duc­tion of vac­cines. We want to avoid that.”

So­cial im­age: WHO head­quar­ters (Alexan­dre Gele­bart, Sipa via AP Im­ages)

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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.