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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

South Korean Olympic table tennis team player Lee Sang-su receiving the first dose of the Pfizer/BioNTech Covid-19 coronavirus vaccine in Seoul (Chung Sung-Jun/Pool Photo via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech do­nate their vac­cine to the Tokyo Olympics; No­vavax, Pfiz­er/BioN­Tech vac­cines ap­pear to be less ef­fec­tive against vari­ants

The long-delayed 2020 Olympics in Tokyo will feature gymnast Simone Biles in what is likely her last Summer Games, and skateboarder Nyjah Huston in what will be his first. But the players with the most impact on the games could be Pfizer and BioNTech. After a meeting between Pfizer CEO Albert Bourla and Japan’s Prime Minister Yoshihide Suga, a plan has been outlined to donate doses of their Covid-19 vaccine for the Olympic Games.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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