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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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Stéphane Bancel, AP Images

Covid-19 roundup: Mod­er­na says vac­cine pro­duces 'strong' re­sponse in 5- to 11-year-olds; As­pen Phar­ma­care plans to up vac­cine pro­duc­tion in South Africa — re­port

After seeing a “robust” immune response in 6- to 11-year-olds dosed with its Covid-19 vaccine, Moderna says it’s headed to the FDA.

The results came from the Phase II/III KidCOVE study, which enrolled 4,753 participants between the ages of 6 and under 12 years old. The kids were given two half-doses of the Moderna vaccine (50 µg each), and showed “strong immune response” a month after the second dose.

AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.