Covid-19 roundup: Har­vard sci­en­tist who in­vest­ed in Mod­er­na ear­ly be­comes a pan­dem­ic bil­lion­aire — and he's giv­ing much of the mon­ey away

Covid-19 has vault­ed a Har­vard pro­fes­sor in­to the glob­al ranks of bil­lion­aires.

Tim­o­thy Springer, the soft-spo­ken, gar­den-tend­ing, Chi­nese rock-col­lect­ing im­mu­nol­o­gist made some head­lines a cou­ple years ago when it got out that he was the 4th largest share­hold­er in Mod­er­na, a com­pa­ny that was launch­ing the largest IPO in biotech his­to­ry. Springer, who made his first for­tune from sell­ing his com­pa­ny LeukoSite to Mil­len­ni­um Phar­ma­ceu­ti­cals for $100 mil­lion, had made an ear­ly $5 mil­lion in­vest­ment in the com­pa­ny in 2010 af­ter founder and fel­low Har­vard sci­en­tist Der­rick Rossi asked him for ad­vice on how to pitch to ven­ture cap­i­tal­ists, who had con­sis­tent­ly passed on his mR­NA-based idea. Even­tu­al­ly Rossi found a tak­er in Flag­ship, who want­ed to build not sim­ply a biotech but es­sen­tial­ly a new phar­ma gi­ant. Mod­er­na went pub­lic in 2018. Springer made $400 mil­lion overnight.

Tim­o­thy Springer

Then, this year, Mod­er­na emerged as the fron­trun­ner to build a vac­cine for Covid-19, quick­ly be­com­ing the first com­pa­ny to put their vac­cine in the clin­ic and re­cent­ly nab­bing a near­ly $500 mil­lion con­tract from BAR­DA. As the virus spread and shook the glob­al econ­o­my by its roots, in­vestors poured mon­ey in­to the biotech. The stock shot up 152% in three-and-a-half months. CEO Stéphane Ban­cel, with his stock op­tions, soon be­came a bil­lion­aire.

And yes­ter­day, Bloomberg re­port­ed, so did Springer. His in­vest­ment in a friend’s start­up is now worth over $800 mil­lion. That’s a 17,000% re­turn. With his oth­er funds, that puts him in­to the biotech bil­lion­aires club, along­side folks like Robert Dug­gan and Patrick Soon-Sh­iong.

It al­so puts him along­side Zoom founder Er­ic Yuan in the per­haps un­com­fort­able but cer­tain­ly en­vi­able po­si­tion of pas­sive­ly prof­it­ing off a pan­dem­ic that has shut down the glob­al econ­o­my and cost 20 mil­lion jobs in the US alone.

Springer said his mon­ey, though, won’t stay in pock­et. Most of it will go to the In­sti­tute for Pro­tein In­no­va­tion, an open source hub he and col­league An­drew Kruse found­ed sev­er­al years ago to de­sign an­ti­bod­ies and oth­er pro­teins as cures for in­tractable dis­eases.

It suits his aca­d­e­m­ic lifestyle, he said, one cen­tered on a sin­gle home in Chest­nut Hill, aca­d­e­mics, gar­den­ing and col­lect­ing gong­shi, or schol­ar’s rocks. Still, if Mod­er­na emerges with a vac­cine for this once-in-a-cen­tu­ry virus, part of the cred­it may be­long to Springer, and to some ad­vice — and $5 mil­lion — he gave to a younger col­league a decade ago. — Ja­son Mast 

Vol­un­teers in NIH tri­al get sec­ond shot of Mod­er­na’s vac­cine

Twen­ty eight days have passed since vol­un­teers in Seat­tle re­ceived their first shot of the first Covid-19 vac­cine to be test­ed in hu­mans. And in­ves­ti­ga­tors are now wel­com­ing them back for the sec­ond in­jec­tion.

The Phase I tri­al, con­duct­ed at Kaiser Per­ma­nente in Seat­tle and Emory Uni­ver­si­ty in At­lanta, Geor­gia, tests Mod­er­na’s mR­NA vac­cine can­di­date. As safe­ty is its main end­point, the fact that it’s still go­ing on is good news.

“The tri­al hasn’t been stopped. We know from the study pro­to­col that if ad­verse events had hap­pened, the pro­to­col would have re­quired that,” Lisa Jack­son, a se­nior in­ves­ti­ga­tor at Kaiser who is lead­ing the tri­al, told USA To­day. “There­fore we pre­sume those things haven’t hap­pened.”

The sec­ond shot that vol­un­teers will re­ceive is in­tend­ed to build on the im­muno­genic­i­ty giv­en by the first primer shot, so that the body can pro­duce an­ti­bod­ies more rapid­ly when it’s ex­posed to the re­al SARS-CoV-2.

Hav­ing en­rolled 45 par­tic­i­pants in the first round, the NIH is ex­pand­ing the tri­al to in­clude 60 more adults over the age of 56.

Mod­er­na — which re­cent­ly se­cured $483 mil­lion from BAR­DA to rapid­ly ramp up man­u­fac­tur­ing and re­cruit 150 more staffers — has in­di­cat­ed that it in­tends to con­tin­ue its break­neck de­vel­op­ment pace and launch a Phase II this quar­ter if the ini­tial re­sults come in pos­i­tive. — Am­ber Tong

Can Farx­i­ga pro­tect Covid-19 pa­tients from or­gan fail­ure and death? As­traZeneca launch­es PhI­II

As doc­tors be­gin to get a clear­er pic­ture of Covid-19’s clin­i­cal man­i­fes­ta­tions, the search for drugs to push back the most se­vere con­se­quences of SARS-CoV-2 in­fec­tion has turned up un­like­ly can­di­dates. In the lat­est ex­am­ple, As­traZeneca has launched a Phase III tri­al to test the abil­i­ty of Farx­i­ga, orig­i­nal­ly ap­proved for di­a­betes, to re­duce the risk of se­ri­ous com­pli­ca­tions and or­gan fail­ure.

Da­ta from its ex­ten­sive Farx­i­ga pro­gram have shown that it has a pro­tec­tive ef­fect in pa­tients with heart fail­ure with re­duced ejec­tion frac­tion (HFrEF), chron­ic kid­ney dis­ease (CKD) and type 2 di­a­betes, As­traZeneca point­ed out. Co­in­ci­den­tal­ly, “car­diac, re­nal and meta­bol­ic co­mor­bidi­ties have been as­so­ci­at­ed with poor out­comes and death in Covid-19 pa­tients.”

The phar­ma gi­ant is team­ing up with Saint Luke’s Mid Amer­i­ca Heart In­sti­tute on the place­bo-con­trolled tri­al, dubbed DARE-19. It will en­roll pa­tients who have a med­ical his­to­ry of hy­per­ten­sion, ath­er­o­scle­rot­ic CV dis­ease, HFrEF, CKD or T2D, and shoot for a di­rect mea­sure of ef­fi­ca­cy: time to first oc­cur­rence of death from any cause or new/wors­ened or­gan dys­func­tion.

All pa­tients will re­ceive stan­dard-of-care ther­a­py.

As­traZeneca has been ac­tive re­pur­pos­ing some of its biggest drugs for Covid-19, re­cent­ly kick­ing off a piv­otal tri­al for the BTK in­hibitor Calquence. That’s on top of ef­forts to dis­cov­er new an­ti­body-based treat­ments that could be de­ployed ear­li­er in dis­ease pro­gres­sion. — Am­ber Tong

Pan­dem­ic im­pacts close to two-thirds of one CRO’s clin­i­cal sites

We’ve all heard, through up­dates from bio­phar­ma com­pa­nies here and there, how the pan­dem­ic is weigh­ing on clin­i­cal tri­als. But what’s the sit­u­a­tion like from a bird’s eye view? A con­tract re­search or­ga­ni­za­tion has pro­vid­ed an­oth­er da­ta point.

ICON, which op­er­ates in 40 coun­tries, re­port­ed in its quar­ter­ly up­date that around 65% of its glob­al clin­i­cal sites were im­pact­ed in some way by the pan­dem­ic.

“Fur­ther­more, we are see­ing Site ID & en­roll­ment de­lays due to site clo­sures and move­ment re­stric­tions on pa­tients. We are proac­tive­ly re­view­ing and agree­ing to al­ter­na­tive ap­proach­es with cus­tomers on a study-by-study ba­sis, in­clud­ing re­mote and risk based mon­i­tor­ing and ‘at home’ ser­vices de­liv­ered through our Sym­pho­ny Clin­i­cal Re­search group,” the com­pa­ny wrote.

Ex­ecs are adopt­ing a cost con­tain­ment plan to weath­er the cri­sis, in­clud­ing salary re­duc­tions, a re­cruit­ment freeze, cut­ting con­trac­tors and oth­er ex­pen­di­tures.

The sil­ver lin­ing is that op­er­a­tions in Chi­na, which be­gan hav­ing is­sues in Feb­ru­ary, are see­ing con­di­tions im­prove since mid-March with sites re-open­ing and mon­i­tor­ing ac­tiv­i­ties re­sum­ing. — Am­ber Tong

UK out­lines na­tion­wide study to test for virus, an­ti­bod­ies and gauge the scale of the out­break

The UK will con­duct a large na­tion­al study to sur­vey the rate of Covid-19 in­fec­tion in its pop­u­la­tion — which should yield cru­cial num­bers to in­form when it can re­lax lock­down mea­sures.

Over 300,000 peo­ple will be test­ed reg­u­lar­ly for the coro­n­avirus over the next year for the virus via self-ad­min­is­tered swabs, 1,000 of whom will al­so be asked to pro­vide blood sam­ples to see if they’ve de­vel­oped an­ti­bod­ies against the virus. Sci­en­tists at Ox­ford are in the process of val­i­dat­ing an an­ti­body test for the tri­al af­ter find­ing that most of the kits the gov­ern­ment has pur­chased give in­ac­cu­rate re­sults.

Health sec­re­tary Matt Han­cock said the study should “con­tin­ue to build up our un­der­stand­ing of this new virus,” such as the ex­tent of com­mu­ni­ty trans­mis­sion and how long im­mu­ni­ty lasts. A pi­lot will be­gin short­ly in­volv­ing 20,000 house­holds.

IQVIA will dis­patch its nurs­es to con­duct home vis­its where they will ask the par­tic­i­pants ques­tions and, when an an­ti­body test is in­volved, draw blood sam­ples. — Am­ber Tong

Chi­nese vac­cine de­vel­op­er notch­es loan and land to scale up man­u­fac­tur­ing as hu­man study gets un­der­way

Sino­vac — one of two Chi­nese de­vel­op­ers to get IND clear­ance for a coro­n­avirus vac­cine tri­al in re­cent days — has quick­ly racked up new loans and land to man­u­fac­ture up to 100 mil­lion shots a year.

The Bank of Bei­jing pro­vid­ed an $8.5 mil­lion (RMB$60 mil­lion) cred­it line to match Sino­vac’s own in­vest­ment while the city gov­ern­ment gave it ac­cess to 70,000 square me­ters of land in the Dax­ing dis­trict. The biotech plans to build a large pro­duc­tion com­plex for mul­ti­ple prod­ucts, with one plant de­vot­ed to the coro­n­avirus vac­cine if it proves ef­fec­tive in tri­als.

“It took one, two weeks for the (lo­cal gov­ern­ment) de­ci­sion,” an anony­mous ex­ec told Reuters. “Pre­vi­ous­ly, two years wouldn’t have been long enough to com­plete ne­go­ti­a­tions.”

The speed un­der­scores the ur­gency for pro­tec­tion against a dead­ly dis­ease that’s killed thou­sands in Chi­na and more than 180,000 world­wide.

Sino­vac is a Nas­daq-list­ed com­pa­ny that mar­kets vac­cines for he­pati­tis A, he­pati­tis B and H1N1 in­fluen­za do­mes­ti­cal­ly. — Am­ber Tong

Azar re­lied on trust­ed aide and side­lined Hahn in ear­ly days of coro­n­avirus re­sponse — re­ports

FDA Com­mis­sion­er Stephen Hahn was ex­clud­ed from the coro­n­avirus task force ear­ly in the US out­break on HHS sec­re­tary Alex Azar’s or­der, Reuters re­port­ed. Rather, the for­mer in­dus­try ex­ec tapped his chief of staff, who had to co­or­di­nate his agency’s re­sponse.

Bri­an Har­ri­son had worked in the of­fice of the deputy HHS sec­re­tary in the George W. Bush ad­min­is­tra­tion — over­lap­ping with Azar’s ear­li­er HHS tenure — and held oth­er fed­er­al po­si­tions be­fore go­ing off to run busi­ness­es in Texas, in­clud­ing a stint breed­ing labradoo­dles, ac­cord­ing to the Wall Street Jour­nal. He was re­cruit­ed back to the HHS in 2018 and pro­mot­ed to chief of staff last June.

Be­fore Vice Pres­i­dent Pence took over from Azar as the head of the coro­n­avirus task force, he re­port­ed­ly served as the key man­ag­er through whom “every­one had to re­port up.” Some White House of­fi­cials ap­par­ent­ly called him “the dog breed­er,” sources told Reuters.

The new re­ports in­ten­si­fy some ap­par­ent in-fight­ing with­in the top de­part­ments tasked with tack­ling the biggest pub­lic health cri­sis the coun­try has seen in years. Rick Bright, un­til re­cent­ly the chief of Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty — an­oth­er HHS unit — said he was oust­ed be­cause he stood against “drugs, vac­cines and oth­er tech­nolo­gies that lack sci­en­tif­ic mer­it.” Specif­i­cal­ly, he cit­ed his cau­tious stance on chloro­quine and hy­drox­y­chloro­quine, which Pres­i­dent Trump tout­ed as po­ten­tial game-chang­ers with­out de­fin­i­tive ev­i­dence. — Am­ber Tong

Cor­rec­tion: An ear­li­er ver­sion of this ar­ti­cle in­cor­rect­ly named a for­mer Do­cuSign chair­man among those who have prof­it­ed dur­ing the Covid-19 pan­dem­ic.

So­cial im­age: Tim­o­thy Springer (Boston Chil­dren’s Hos­pi­tal)

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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