Moncef Slaoui, head of Operation Warp Speed (AP Images)

Covid-19 roundup: No­vavax re­cruits As­traZeneca vet as its new CMO — right af­ter David Mott jumps on the board; Op­er­a­tion Warp Speed will cut to 7 can­di­dates

One of the dark-horse con­tenders in a race to the fin­ish line with a new vac­cine for Covid-19 has just wooed a se­nior As­traZeneca re­searcher to the fold as its new chief med­ical of­fi­cer.

Fil­ip Dubovsky

No­vavax re­ports that it has re­cruit­ed Fil­ip Dubovsky to the team af­ter a 14-year stretch at Med­Im­mune/As­traZeneca. While at the big As­traZeneca sub, Dubovsky had been area head for in­fec­tious dis­eases and vac­cines. Ear­li­er he had been sci­en­tif­ic di­rec­tor for PATH, a malar­ia vac­cine ini­tia­tive.

David Mott

Dubovsky’s ar­rival comes 1 day af­ter No­vavax an­nounced that David Mott — the ex-CEO at Med­Im­mune re­cent­ly re­tired from a top spot at New En­ter­prise As­so­ci­ates — is join­ing the board.

No­vavax al­so hired Sil­via Tay­lor, as SVP, in­vestor re­la­tions and cor­po­rate af­fairs.

No­vavax jumped in­to the race with a seed grant from the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions, which fol­lowed up with a grant of up to $384 mil­lion. And just yes­ter­day, the com­pa­ny raised $200 mil­lion in an eq­ui­ty in­vest­ment from RA Cap­i­tal. But the biotech has been no­tice­ably ab­sent from the fron­trun­ners cit­ed by Op­er­a­tion Warp Speed — so far in any case. — John Car­roll

Stéphane Ban­cel pre­dicts Mod­er­na vac­cine has 80% to 90% chance of suc­cess

It would come as no sur­prise that Stéphane Ban­cel is bull­ish about Mod­er­na’s Covid-19 vac­cine can­di­date, which has gar­nered plen­ty of at­ten­tion as the fron­trun­ning project most steps of the way. But just how bull­ish may yet turn some heads.

In an in­ter­view with CN­BC, Ban­cel went on the record giv­ing it an 80% to 90% chance that mR­NA-1273 can re­duce the risk of dis­ease by half, or ef­fi­ca­cy of above 50% in tech­ni­cal speak.

“At the pub­lic health lev­el, a vac­cine with 50% [ef­fi­ca­cy] will slow down dras­ti­cal­ly in­fec­tions,” Ban­cel said, even if it doesn’t pro­tect every­one who gets ex­posed to SARS-CoV-2.

He was cau­tious not to com­mit to a prob­a­bil­i­ty around 90% ef­fi­ca­cy, say­ing he’d need more da­ta to as­sess. Yet the op­ti­mism is still ex­tra­or­di­nary: As CN­BC not­ed, new vac­cines en­ter­ing hu­man tri­als from 2000 to 2015 had about a 1-in-3 chance of get­ting ap­proval.

Ban­cel cites sev­er­al rea­sons why Mod­er­na, a 10-year-old start­up, was able to leapfrog sto­ried bio­phar­ma play­ers. The mR­NA tech­nol­o­gy lends it­self to rapid turn­around; it’s been test­ed against nine oth­er pathogens; it had a tri­al run with part­ners at the NIH in MERS; and it boasts of its own man­u­fac­tur­ing site near its head­quar­ters in Boston.

Hav­ing tout­ed — some­what con­tro­ver­sial­ly — an an­ti­body re­sponse from eight pa­tients in the Phase I tri­al and more re­cent­ly re­leased an­i­mal da­ta, Mod­er­na has out­lined a 30,000-per­son Phase III tri­al to be­gin in Ju­ly. The goal is to have a vac­cine ready to de­ploy by the end of the year — a goal NI­AID di­rec­tor An­tho­ny Fau­ci has called “as­pi­ra­tional, but it’s cer­tain­ly doable.” — Am­ber Tong

For­mer Shkre­li biotech surges on cy­tokine storm drug

The stock of one of Mar­tin Shkre­li’s for­mer biotechs has been soar­ing over the last month, from less than a $1 to more than $5 per share.

Hu­mani­gen, which for sev­er­al weeks in 2015 was run by the in­fa­mous “Phar­ma Bro,” makes an­ti-in­flam­ma­to­ries for use in, among oth­er things, the hy­per­ac­tive im­mune re­spons­es, called cy­tokine storms, that of­ten af­flict pa­tients who re­ceive CAR-T can­cer treat­ments. That made their drug a nat­ur­al fit for Covid-19 af­ter doc­tors de­ter­mined these storms were caus­ing some of the worst symp­toms in in­fect­ed pa­tients.

Still, the da­ta on their drug, a GM-CSF in­hibitor called lenzilum­ab, are still high­ly lim­it­ed. In a non-con­trolled preprint post­ed on MedRx­iv ear­li­er this week, 12 pa­tients with se­vere pneu­mo­nia and at least one co-mor­bid­i­ty as­so­ci­at­ed with poor Covid-19 out­comes, were giv­en the drug. Of those, 11 were dis­charged with­in 5 days, with no treat­ment-emer­gent ad­verse ef­fects.

That par­tic­u­lar round of da­ta sent their stock from $4.08 to $5.45. The com­pa­ny plans to test their drug in larg­er tri­als.

Shkre­li and an in­vestor group bought a ma­jor­i­ty stake in the com­pa­ny, then known as Kalo­Bios, in 2015. But when Shkre­li was ar­rest­ed for se­cu­ri­ty fraud for his deal­ings at a dif­fer­ent com­pa­ny, Kalo­Bios fired him. It filed for bank­rupt­cy soon af­ter and re-emerged in 2016 as Hu­mani­gen.

On June 2, Ven­rock, Citadel, and Valiant in­vest­ed $72 mil­lion in­to the com­pa­ny, spurring the ini­tial resur­gence in val­ue and prep­ping the com­pa­ny for scal­ing the drug should it be ap­proved.

CEO Cameron Dur­rant, in an in­ter­view with the Wall Street Jour­nal, called Shkre­li’s time at the com­pa­ny an “un­for­tu­nate his­to­ry” that last­ed rough­ly 3 weeks.

Op­er­a­tion Warp Speed will cut to 7 can­di­dates, make vac­cine free for ‘vul­ner­a­ble’

The New York Times re­port­ed ear­li­er this month that the Trump ad­min­is­tra­tion had whit­tled Op­er­a­tion Warp Speed from 14 to 5 dif­fer­ent vac­cine can­di­dates, but HHS said yes­ter­day that there would be 7 can­di­dates that move be­yond the ini­tial list.

And for “vul­ner­a­ble” Amer­i­cans, any vac­cine that comes out of the project will be free.

The num­ber of can­di­dates be­yond the ini­tial list, in line with ear­ly re­port­ing from Bloomberg, give re­newed hope for vac­cine de­vel­op­ers who were left off the ini­tial re­port­ed list. That in­cludes No­vavax and In­ovio, both of which are in Phase I, and Sanofi, a com­pa­ny long backed by HHS and which ex­pects to put their vac­cine in­to clin­i­cal test­ing by the end of the year.

The list of 7 will then be win­nowed to a small­er, un­spec­i­fied num­ber of fi­nal­ists. The 7 will re­ceive fund­ing and as­sis­tance for ear­ly tri­als, and the fi­nal few will re­ceive aid for large-scale test­ing and man­u­fac­ture. The first of those large tri­als are ex­pect­ed to come this sum­mer: from Mod­er­na, As­traZeneca and J&J, in that or­der. The work of scal­ing is al­so un­der­way, most re­cent­ly with fed­er­al con­tracts of $628 mil­lion for Emer­gent BioSo­lu­tions and a $204 mil­lion for Corn­ing, who will make vials to store and dis­trib­ute a vac­cine.

Ques­tions of price have been thorny so far for the top vac­cine de­vel­op­ers. Some, such as J&J and As­traZeneca, have said they will not prof­it on the vac­cine. Mod­er­na and Pfiz­er have said they will not charge ex­or­bi­tant­ly.

Ad­min­is­tra­tion of­fi­cials pledged to make the vac­cine avail­able to those who can’t af­ford it or are “vul­ner­a­ble” on a con­fer­ence call yes­ter­day, ac­cord­ing to sev­er­al me­dia re­ports. The of­fi­cials al­so said that they can’t guar­an­tee a vac­cine will be avail­able by Jan­u­ary, the wide­ly re­port­ed aim of the ini­tia­tive. — Ja­son Mast

Cure­Vac en­ters the clin­ic af­ter sev­er­al tu­mul­tuous months

Two days af­ter the Ger­man gov­ern­ment poured €300 mil­lion in­to the mR­NA biotech Cure­Vac, the com­pa­ny an­nounced it will put their vac­cine in­to hu­man tri­als.

Al­though strag­gling some of the oth­er ma­jor play­ers, the date of the an­nounce­ment is in line with the time­line Cure­Vac laid out over the win­ter. Still, it comes on the heels of three tu­mul­tuous months for a com­pa­ny that pre­vi­ous­ly reached uni­corn sta­tus while large­ly avoid­ing con­tro­ver­sial head­lines.

Ar­guably the first biotech built around mR­NA, Cure­Vac was one of the first com­pa­nies to pub­licly be­gin work on a Covid-19 vac­cine af­ter the out­break emerged, and they were quick­ly backed by the Cen­ter for Epi­dem­ic Pre­pared­ness In­no­va­tions.

Then a flur­ry of head­lines hit over a sin­gle week in March. First CEO Daniel Menichel­la was re­placed by found­ing CEO In­g­mar Ho­err. The com­pa­ny cit­ed the need for lead­er­ship with a sci­en­tif­ic back­ground dur­ing a cri­sis, but the news of a CEO shift in the mid­dle of an un­prece­dent­ed vac­cine race prompt­ed wide spec­u­la­tion.

Then lat­er that week, Reuters and a promi­nent Ger­man pa­per re­port­ed that the Trump ad­min­is­tra­tion had tried to lure Cure­Vac to the US to se­cure ac­cess to their Covid-19 vac­cine, alarm­ing Ger­man of­fi­cials and be­gin­ning what has since been months of in­ter­na­tion­al tus­sling over vac­cine ac­cess. (Cure­Vac de­nied the re­ports, but the New York Times sub­se­quent­ly re­port­ed sim­i­lar­ly). The EU sub­se­quent­ly made €80 mil­lion avail­able to Cure­Vac to shore up man­u­fac­tur­ing on the con­ti­nent — on the same day Ho­err an­nounced that, af­ter a week-long re­turn, he was step­ping down for med­ical rea­sons and CCO Franz-Wern­er Haas would step in as act­ing CEO.

The con­cerns over ac­cess to Cure­Vac’s vac­cine haven’t dis­si­pat­ed. The Fi­nan­cial Times re­port­ed that the €300 mil­lion Ger­man gov­ern­ment in­vest­ment was in­tend­ed to ward off a planned IPO. FT cit­ed a doc­u­ment from the Ger­man Fi­nance Min­istry: “The in­tend­ed ac­qui­si­tion of a fed­er­al share­hold­ing in Cure­Vac is in­tend­ed to en­sure that the com­pa­ny is not tak­en over by a for­eign in­vestor and that it does not leave the coun­try … It is feared that in case of takeover and mi­gra­tion abroad, a vac­cine against Covid-19 de­vel­oped by Cure­Vac in the fu­ture will not be made avail­able to Ger­many and Eu­rope.”

Un­like Mod­er­na or the Pfiz­er-part­nered vac­cine de­vel­op­er BioN­Tech, Cure­Vac us­es a form of mR­NA vac­cine that trig­gers an in­nate im­mune re­sponse, which they’ve long tout­ed as al­low­ing them to give much small­er dos­es and thus pro­duce far more vac­cines. (Mod­er­na con­sid­ered the tech­nol­o­gy ear­ly in its his­to­ry and de­cid­ed against it.) Their first tri­al, set to take place in Bel­gium and Ger­many, will test be­tween 2 and 8 mi­cro­grams in 168 pa­tients. Mod­er­na, by con­trast, test­ed be­tween 10 and 200 mi­cro­grams. — Ja­son Mast

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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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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”