Covid-19 roundup: An old, cheap steroid proves to be a ma­jor boon to coro­n­avirus pa­tients; BAR­DA puts $85M be­hind Re­gen­eron an­ti­body ef­fort

Re­searchers to­day spot­light­ed da­ta from a clin­i­cal study of­fer­ing the first hard ev­i­dence that a treat­ment can save the lives of pa­tients suf­fer­ing from Covid-19.

The old gener­ic dex­am­etha­sone was tied to a one-third re­duc­tion of deaths among ven­ti­lat­ed pa­tients with a one-fifth re­duc­tion in mor­tal­i­ty among a group get­ting oxy­gen. There was no ben­e­fit for pa­tients who did not re­quire res­pi­ra­to­ry as­sis­tance.

“Dex­am­etha­sone is the first drug to be shown to im­prove sur­vival in COVID-19,” not­ed Pe­ter Hor­by, an Ox­ford pro­fes­sor and a chief in­ves­ti­ga­tor in the tri­al. “This is an ex­treme­ly wel­come re­sult. The sur­vival ben­e­fit is clear and large in those pa­tients who are sick enough to re­quire oxy­gen treat­ment, so dex­am­etha­sone should now be­come stan­dard of care in these pa­tients. Dex­am­etha­sone is in­ex­pen­sive, on the shelf, and can be used im­me­di­ate­ly to save lives world­wide.”

“(I)t is fan­tas­tic that the first treat­ment demon­strat­ed to re­duce mor­tal­i­ty is one that is in­stant­ly avail­able and af­ford­able world­wide,” en­thused Ox­ford’s Mar­tin Lan­dray. — John Car­roll

BAR­DA puts $85M be­hind Re­gen­eron’s an­ti­body ef­fort

BAR­DA, the US biode­fense agency, is back­ing Re­gen­eron’s Covid-19 an­tivi­ral an­ti­body ef­fort with $85 mil­lion.

Al­though BAR­DA has al­ready promised over $2 bil­lion to ac­cel­er­ate and scale the de­vel­op­ment of Covid-19 vac­cines, but this is the largest tranche of fund­ing yet for a treat­ment ef­fort. BAR­DA worked with Re­gen­eron on their Ebo­la an­ti­body ef­fort – help­ing lead to one of the first two suc­cess­ful treat­ments for the virus in a tri­al last Au­gust – and the pair first an­nounced col­lab­o­ra­tion on a sim­i­lar ef­fort for Covid-19 in Feb­ru­ary.

The news of the fund­ing comes days af­ter Re­gen­eron put their first cock­tail of an­ti­bod­ies in the clin­ic. The Tar­ry­town-based biotech plans to even­tu­al­ly run 4 tri­als, 2 of them test­ing the drug as a treat­ment and 2 as a pro­phy­lac­tic.

HHS has al­so fund­ed an­ti­body ef­forts from As­traZeneca and SAb Bio­ther­a­peu­tics. Roche and J&J, among oth­ers, have re­ceived fund­ing for oth­er types of treat­ment. — Ja­son Mast

Pe­ter Kolchin­sky of­fers Covid-19 play­er No­vavax a thumbs up and $200M 

RA Cap­i­tal’s Pe­ter Kolchin­sky is back­ing No­vavax’s Covid-19 play, to the tune of $200 mil­lion.

A fund af­fil­i­at­ed with RA is buy­ing 4.4 mil­lion shares of stock $NVAX in the com­pa­ny at the June 12 clos­ing price.

Covid-19 has been a big help for No­vavax, which has had its share of clin­i­cal fail­ures to deal with. CEPI stepped up with its largest com­mit­ment to date, back­ing the biotech’s Phase I and Phase II tri­als for NVX-CoV2373 for up to $384 mil­lion while “dra­mat­i­cal­ly” in­creas­ing its pro­duc­tion ca­pac­i­ty for the vac­cine anti­gen as well as the ad­ju­vant need­ed to boost its ef­fi­ca­cy. That mon­ey was added on top of the $4 mil­lion CEPI sent No­vavax to get things go­ing in R&D with­out any de­lays for ne­go­ti­a­tions.

“The glob­al vac­cine ef­fort is search­ing for can­di­dates that are ca­pa­ble of both gen­er­at­ing the high­est neu­tral­iz­ing an­ti­body titers and large-scale pro­duc­tion. We are ex­cit­ed to in­crease our in­vest­ment in No­vavax, which along with re­sources from CEPI and the U.S. De­part­ment of De­fense, will sup­port No­vavax in its im­por­tant work de­vel­op­ing an ef­fec­tive, scal­able vac­cine for SARS-CoV-2,” said Kolchin­sky in a state­ment. — John Car­roll

Sanofi sets aside $679M cash for new vac­cine sites in France

As Sanofi push­es its par­al­lel R&D ef­forts on a pair of Covid-19 vac­cine can­di­dates, the French drug­mak­er said it would pour $679.4 mil­lion (€610 mil­lion) in­to two vac­cine sites on its home turf.

The com­mit­ment to “make France its world class cen­ter of ex­cel­lence” comes just weeks af­ter CEO Paul Hud­son, a Brit, drew the ire of French min­is­ters by say­ing in an in­ter­view that the US gov­ern­ment “has the right to the largest pre-or­der be­cause it’s in­vest­ed in tak­ing the risk” — a com­ment Sanofi swift­ly walked back.

“Sanofi’s heart beats in France,” Hud­son said in a pre­pared state­ment. “Sanofi is a ma­jor health­care play­er in France, in Eu­rope, and world­wide. It is our re­spon­si­bil­i­ty to fo­cus our re­sources and ex­per­tise against the cur­rent pan­dem­ic, but al­so to in­vest in prepar­ing for fu­ture ones.”.

French au­thor­i­ties have been work­ing with Sanofi the last sev­er­al months to achieve this, he added, in a com­ment that echoed Ger­many’s de­ci­sion to buy a stake of mR­NA biotech Cure­Vac with €300 mil­lion in fed­er­al mon­ey. And Pres­i­dent Em­manuel Macron came through with a pledge of €200 mil­lion to fu­el do­mes­tic re­search and man­u­fac­tur­ing, a boost Hud­son has been ad­vo­cat­ing for.

“Every­body saw that dur­ing this cri­sis some com­mon­ly used drugs were no longer pro­duced in France and Eu­rope. So we must no longer just ask ques­tions, but draw the con­clu­sions,” Macron said at Sanofi’s Mar­cy-L’Étoile fa­cil­i­ty.

At the same time — and it might have been drowned out by the Syn­thorx buy­out and dra­mat­ic cuts in the car­dio and di­a­betes units — the com­pa­ny re­mind­ed read­ers of the press re­lease that vac­cines were iden­ti­fied as a key area for growth in the cor­po­rate strat­e­gy Hud­son laid out last year.

Sanofi plans to build a vac­cine pro­duc­tion site at Neuville-sur-Saône and a re­search cen­ter at Mar­cy-l’Étoile, cre­at­ing a whole chain from R&D to man­u­fac­tur­ing with­in the coun­try.

The for­mer fa­cil­i­ty will cost an es­ti­mat­ed €490 mil­lion over five years and is ex­pect­ed to cre­ate 200 new jobs. The lat­ter will fo­cus on de­vel­op­ing fu­ture vac­cines, with high­ly-spe­cial­ized labs fo­cused on emerg­ing dis­eases and pan­dem­ic risks. — Am­ber Tong

Im­pe­r­i­al Col­lege of Lon­don preps Phase I tri­al of mR­NA vac­cine

A new mR­NA vac­cine ef­fort is en­ter­ing the clin­ic.

Three months af­ter Mod­er­na be­gan hu­man Covid-19 vac­cine test­ing with an mR­NA can­di­date, a can­di­date based on sim­i­lar tech­nol­o­gy from the Im­pe­r­i­al Col­lege of Lon­don will go in­to an ear­ly-stage tri­al this week, Reuters re­port­ed.

Un­like vir­tu­al­ly every oth­er clin­i­cal-stage Covid-19 vac­cine, the Im­pe­r­i­al Col­lege does not have a ma­jor in­dus­try part­ner. In­stead they’ve re­ceived over $56.5 mil­lion in fund­ing from par­lia­ment and donors, and have set up a new ven­ture for com­mer­cial­iz­ing the vac­cine should it prove safe and ef­fec­tive.

Al­though sim­i­lar in prin­ci­ple to Mod­er­na’s can­di­date — putting the ge­net­ic code for a coro­n­avirus pro­tein in­to hu­man cells, which ex­press the pro­tein and trig­ger an im­mune re­sponse — the col­lege’s tech­nol­o­gy dif­fers in key ways. Called small-am­pli­fy­ing RNA, the ge­net­ic code in the vac­cine will repli­cate it­self in­side cells, al­low­ing for much small­er dos­es and thus a po­ten­tial­ly much broad­er scale. It was de­vel­oped in part by Robin Shat­tock, who has al­so de­signed the Covid-19 can­di­date.

To com­mer­cial­ize the vac­cine, the col­lege set up a new com­pa­ny called VacE­quity Glob­al Health with the Hong Kong-based in­vest­ment firm Morn­ing­side Ven­tures. Its goal will be to make the vac­cine as wide­ly avail­able as pos­si­ble, while still turn­ing a prof­it — pos­si­bly by sell­ing for slight­ly high­er prices in high-in­come than low-in­come coun­tries.

The vac­cine will be one of sev­er­al that en­ter the clin­ic in the com­ing weeks and months. Cure­Vac, one of the first biotechs to be­gin de­vel­op­ing a vac­cine and which al­so us­es mR­NA, said ear­ly in the pan­dem­ic that they would aim for tri­als in June. And to­day sci­en­tists in Sin­ga­pore said they would be­gin test­ing an mR­NA vac­cine from the US biotech Arc­turus in Au­gust. — Ja­son Mast

As­traZeneca re­veals more of man­u­fac­tur­ing plan, adds an­oth­er part­ner

The streak of man­u­fac­tur­ing and sup­ply deals As­traZeneca has struck for Ox­ford’s Covid-19 vac­cine, cou­pled with rapid progress on the clin­i­cal front, ap­pears to have em­bold­ened the com­pa­ny in di­al­ing up its hopes, with CEO Pas­cal So­ri­ot pre­dict­ing that the pro­tec­tion would last for about a year, as re­port­ed by Reuters.

Un­der ide­al cir­cum­stances — which would in­volve enough vol­un­teers giv­en place­bo get in­fect­ed by the coro­n­avirus — re­sults of the on­go­ing Phase III tri­als will be ready in Au­gust or Sep­tem­ber.

“We are man­u­fac­tur­ing in par­al­lel,” he added. “We will be ready to de­liv­er from Oc­to­ber if all goes well.”

Through a glob­al net­work of part­ners, As­traZeneca said it’s se­cured ca­pac­i­ty for 2 bil­lion dos­es through 2021. A grow­ing list of part­ners have re­served more than half of that col­lec­tive­ly: 400 mil­lion dos­es for Eu­rope in its lat­est deal with France, Ger­many, Italy and the Nether­lands; 300 mil­lion for the US; 100 mil­lion for the UK; and 400 mil­lion to low- and mid­dle-in­come coun­tries by the end of the year.

On Tues­day the phar­ma gi­ant added Co­bra Bi­o­log­ics to the con­trac­tor fold, task­ing the UK man­u­fac­tur­er with pro­vid­ing GMP man­u­fac­ture of the vac­cine can­di­date AZD1222.

Co­bra had be­gun work­ing with Ox­ford’s Jen­ner In­sti­tute in March, be­fore As­traZeneca jumped on board with its pow­er­house in­fra­struc­ture. The sci­en­tists who de­vel­oped the re­com­bi­nant ade­n­ovirus vec­tor im­mu­niza­tion were think­ing about mass pro­duc­tion ear­ly on; some of the com­pa­nies that they had tapped for their man­u­fac­tur­ing con­sor­tium, such as Ox­ford Bio­med­ica, have since teamed up with As­traZeneca.

“The agree­ment with As­traZeneca comes at an op­por­tune time for us as we bring three ad­di­tion­al vi­ral vec­tor suites on­line as part of our on­go­ing ad­vanced ther­a­pies ex­pan­sion pro­gramme,” Pe­ter Cole­man, chief ex­ec­u­tive at Co­bra, said in a state­ment. — Am­ber Tong

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

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

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.”

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.

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 of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

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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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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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month to discuss the development and authorization of Covid-19 vaccines, the chairwoman won’t be there.

Hana El Sahly has recused herself from the expert panel’s review of the topic, citing her role as a lead investigator in Moderna’s Phase III trial, Reuters reported. An associate professor of virology and microbiology at Baylor College of Medicine in Houston, El Sahly was appointed the chairwoman last year.

Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.