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 Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.