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

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

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.