Covid-19 roundup: Yet more dos­es of the As­traZeneca-Ox­ford vac­cine; A sec­ond ran­dom­ized hy­drox­y­chloro­quine study fails

An­oth­er gene ther­a­py com­pa­ny is of­fer­ing its fa­cil­i­ties to the Covid-19 fight.

Ox­ford Bio­med­ica, a 90s-era spin­out of Ox­ford Uni­ver­si­ty, has signed a 5-year agree­ment to help man­u­fac­ture the Covid-19 vac­cine be­ing de­vel­oped by Ox­ford Uni­ver­si­ty’s Jen­ner In­sti­tute and As­traZeneca. The deal is with the Vac­cines Man­u­fac­tur­ing and In­no­va­tion Cen­tre, a gov­ern­ment-spon­sored non-prof­it set up 2 years ago to shore up the isle’s vac­cine man­u­fac­tur­ing ca­pac­i­ty.

The part­ner­ship works be­cause of the par­tic­u­lar type of vac­cine the Jen­ner In­sti­tute it’s de­vel­op­ing. An ade­n­ovi­ral vec­tor, the vac­cine can­di­date us­es a weak­ened ver­sion of a com­mon cold-caus­ing virus to de­liv­er the gene for a coro­n­avirus in­to hu­man cells. It’s a sim­i­lar sys­tem to the one gene and cell ther­a­py com­pa­nies like Bio­med­ica or AveX­is — which last month agreed to man­u­fac­ture a vac­cine based on a sim­i­lar tech­nol­o­gy — use to de­liv­er their ther­a­pies.  Along­side its own pipeline, the UK biotech helps sup­ply the lentivi­ral vec­tors used in No­var­tis’s CAR-T treat­ment Kym­ri­ah.

Bio­med­ica first an­nounced it was work­ing with the Jen­ner In­sti­tute in ear­ly April, when they joined a con­sor­tium ded­i­cat­ed to push­ing their vac­cine for­ward. But the new agree­ment fi­nal­izes the part­ner­ship and calls for the Vac­cines Man­u­fac­tur­ing and In­no­va­tion Cen­tre to help the biotech out­fit two new man­u­fac­tur­ing sites, with an eye to­ward sat­is­fy­ing UK and EU de­mand for a vac­cine, should it prove ef­fec­tive.

Chi­nese biotech brings sec­ond an­ti­body in­to clin­ic

A week af­ter Eli Lil­ly and its biotech part­ner Ab­Cellera brought the first Covid-19 an­ti­body ther­a­py in­to the clin­ic, Shang­hai-based Jun­shi Bio­sciences has brought the sec­ond.

Jun­shi dosed their first pa­tient in Chi­na, though the com­pa­ny has its own part­ner­ship with Lil­ly and will start a US tri­al on the drug can­di­date, known as JS016, in the sec­ond quar­ter of the year. Phase I is in healthy vol­un­teers and will test safe­ty and im­muno­genic­i­ty.

Nu­mer­ous com­pa­nies, promi­nent and ob­scure, are try­ing to de­vel­op an­ti­bod­ies that can treat or pre­vent Covid-19. These lab-grown mol­e­cules mim­ic the body’s nat­ur­al best de­fense against for­eign in­vaders and have proven the best treat­ments for oth­er pathogens, in­clud­ing an­thrax, RSV, and Ebo­la. Two of the most watched ef­forts are the ones from Re­gen­eron and Vir Biotech­nol­o­gy, both of which are set to en­ter the clin­ic in the com­ing weeks and months.

Most re­cent­ly Ab­b­Vie stepped in­to the race, sign­ing a col­lab­o­ra­tion with the Chi­nese biotech Har­bour Med and a pair of Dutch aca­d­e­m­ic and med­ical cen­ters. An­ti­bod­ies are par­tic­u­lar­ly dif­fi­cult to man­u­fac­ture, and, like vac­cines, mul­ti­ple can­di­dates may be need­ed. Jun­shi said they can make 100,000 dos­es by the end of the year.

Sec­ond hyr­doxy­chloro­quine RCT fails, this time in hos­pi­tal­ized pa­tients

Days af­ter a large Uni­ver­si­ty of Min­neso­ta study found the an­ti-malar­i­al hy­drox­y­chloro­quine didn’t pre­vent ex­posed pa­tients from de­vel­op­ing Covid-19, UK sci­en­tists have halt­ed a tri­al af­ter find­ing that the drug had no ef­fect on hos­pi­tal­ized pa­tients.

”This is not a treat­ment for Covid-19. It doesn’t work,” lead in­ves­ti­ga­tor and Ox­ford Uni­ver­si­ty pro­fes­sor Mar­tin Lan­dray told re­porters, per Reuters. “This re­sult should change med­ical prac­tice world­wide. We can now stop us­ing a drug that is worth­less.”

The re­sults add to a grow­ing, if some­times mud­dled body of ev­i­dence against a drug that doc­tors iden­ti­fied ear­ly as one of the po­ten­tial off-the-shelf treat­ments for the virus and which be­came one of the most talked-about and stud­ied ther­a­pies af­ter Pres­i­dent Trump tout­ed it in press con­fer­ences, of­ten over the ad­vice of med­ical ex­perts.

While re­searchers raced to test the drug in ran­dom­ized, con­trolled tri­als, doc­tors — boost­ed by an FDA emer­gency use au­tho­riza­tion for the pill and lack­ing oth­er good op­tions — pre­scribed it for their Covid-19 pa­tients. Two of the ear­li­est pieces of ev­i­dence against its use as a coro­n­avirus treat­ment then were pub­li­ca­tions in the New Eng­land Jour­nal of Med­i­cine and the Lancet that tracked med­ical records of pa­tients world­wide who had been giv­en the drug and found hy­drox­y­chloro­quine ac­tu­al­ly raised the risk of death.

Both of those tri­als were, in a no­table and high­ly un­usu­al event for the pres­ti­gious jour­nals, re­tract­ed last week af­ter in­ves­ti­ga­tors found they were un­able to ver­i­fy the da­ta, which had been col­lect­ed by a tiny US firm with ques­tion­able sci­en­tif­ic ex­per­tise. Those stud­ies had in­formed de­ci­sions by WHO and sev­er­al re­search in­sti­tutes to halt tri­als on the drug, and their re­trac­tion in the­o­ry opened the door for the drug to still prove ef­fec­tive.

But the re­trac­tions came just as the first and much-an­tic­i­pat­ed ran­dom­ized con­trolled tri­als — the gold stan­dard when it comes to eval­u­at­ing drugs — came out. First, in NE­JM, the Uni­ver­si­ty of Min­neso­ta found that across 821 pa­tients, hy­drox­y­chloro­quine didn’t work as post-ex­po­sure pro­phy­lax­is.

Now, the UK tri­al found it didn’t work in hos­pi­tal­ized pa­tients. In­ves­ti­ga­tors as­signed 1,542 pa­tients to hy­drox­y­chloro­quine and com­pared them with 3,132 pa­tients ran­dom­ly as­signed to stan­dard of care. There was no sig­nif­i­cant dif­fer­ence in death rates af­ter 28 days, length of stay in the hos­pi­tal or oth­er out­comes.

Tri­als are for now con­tin­u­ing around the world for the an­ti-malar­i­al and some doc­tors con­tin­ue to see po­ten­tial ben­e­fit, but the in­ves­ti­ga­tors in both of the ran­dom­ized con­trolled stud­ies were blunt in their as­sess­ments.

“Now that we know there is no ben­e­fit and we know there are side ef­fects, there is re­al­ly no rea­son to take this drug fur­ther,” the Uni­ver­si­ty of Min­neso­ta’s Rad­ha Ra­jas­ing­ham told End­points News last week.

Lan­dray, the Ox­ford pro­fes­sor, said sim­ply: “If you’re ad­mit­ted to hos­pi­tal, don’t take hy­drox­y­chloro­quine.”

A UK vac­cine lab tries to get around the in­dus­try

All roads to a Covid-19 vac­cine so far have led through Big Phar­ma. Now a promi­nent British lab is try­ing to change that.

Robin Shat­tock, the sci­en­tist be­hind the vac­cine project at the Im­pe­r­i­al Col­lege of Lon­don, told the New York Times to­day that the col­lege is start­ing a new “so­cial en­ter­prise” that would en­sure Shat­tock’s vac­cine is avail­able at the low­est pos­si­ble cost both in the UK and in low- and mid­dle-in­come coun­tries. The Im­pe­r­i­al Col­lege’s work is one of two aca­d­e­m­ic Covid-19 vac­cine projects the UK gov­ern­ment has poured tens of mil­lions of pounds in­to, along­side the much-pub­li­cized Ox­ford Uni­ver­si­ty can­di­date.

The new com­pa­ny will be called VacE­quity Glob­al Health and found­ed in part­ner­ship with the Hong-Kong based in­vest­ment firm Morn­ing­side Ven­tures. While aim­ing to make the vac­cine wide­ly ac­ces­si­ble, VacE­quity will al­so be for-prof­it and may charge high­er rates in wealth­i­er coun­tries.

The new ven­ture comes amid a grow­ing de­bate over how to best to scale up and al­lo­cate a Covid-19 vac­cine once one (or sev­er­al) proved ef­fec­tive, par­tic­u­lar­ly for mid­dle-in­come coun­tries. With the US and the UK fund­ing can­di­dates ear­ly and lav­ish­ly in ex­change for pref­er­en­tial ac­cess, the EU has re­cent­ly sig­naled they would make sim­i­lar in­vest­ments, and GAVI — the Gates-backed non­prof­it that works on vac­ci­na­tion across the de­vel­op­ing world — is try­ing to do the same.

Al­most all of these ef­forts, though, go through ex­ist­ing big biotech and phar­ma com­pa­nies. Ox­ford part­nered with As­traZeneca on their vac­cine, and have since signed agree­ments with the US, the UK and en­ti­ties in oth­er coun­tries promis­ing to sup­ply up to 2 bil­lion dos­es of a vac­cine on a “no prof­it” ba­sis. Mod­er­na, de­vel­op­ing a vac­cine de­signed in part at the NIH, signed a deal with the Swiss CMO Lon­za to scale up to 1 bil­lion dos­es by next year.

The col­lege thinks they may have an up­per hand on scale be­cause of the tech­nol­o­gy they use, called self-am­pli­fy­ing RNA. It is sim­i­lar to the tech­nol­o­gy used in the vac­cines be­ing de­vel­oped by Mod­er­na and the Pfiz­er-BioN­Tech col­lab­o­ra­tion — de­liv­er­ing the ge­net­ic code for the virus anti­gen — but it can be giv­en in much small­er dos­es be­cause the RNA makes copies of it­self af­ter it’s been in­ject­ed. An­oth­er RNA vac­cine ef­fort from Cure­Vac is al­so de­signed to be giv­en at much small­er dos­es, al­though that one works by trig­ger­ing an im­me­di­ate im­mune re­sponse.

Shat­tock’s vac­cine is set to en­ter a Phase I/II on June 15,  fol­lowed by a 6,000-per­son ef­fi­ca­cy tri­al in Oc­to­ber.

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

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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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

Over the past 4 months, a group of analysts at GlobalData tracked 322 biopharma companies — biotechs, pharmas, CROs and such — reporting on the trouble Covid-19 has caused for their clinical development plans.

Slightly more than half — 179 — are US operations, with about 1 in 4 scattered throughout Europe and in Canada. And the disruptions are clustered around mid-stage development, though a hefty number of late-stage derailments may well blunt the stream of approvals down the road.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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