Covid-19 roundup: Chi­na's Sino­vac goes to Brazil for PhI­II; As­traZeneca signs Emer­gent on for $87M man­u­fac­tur­ing deal

Sino­vac, the first Chi­nese biotech to pub­lish an­i­mal da­ta on a Covid-19 vac­cine, is team­ing up with a Brazil­ian part­ner to test its can­di­date in the South Amer­i­can coun­try.

In­sti­tu­to Bu­tan­tan is still await­ing clear­ance from lo­cal au­thor­i­ties to kick off the Phase III tri­al, which will en­roll 9,000 peo­ple in Ju­ly. The com­pa­ny will get a li­cense for the vac­cine in Brazil should it prove ef­fec­tive.

As new in­fec­tions in Chi­na be­come a rare oc­cur­rence, sci­en­tists have run in­to the bizarre prob­lem of not hav­ing enough ex­po­sure to re­al­ly know whether the in­oc­u­la­tions are pro­tect­ing their vol­un­teers.

CanSi­no Bi­o­log­ics, the lead­ing de­vel­op­er, has turned to Cana­da for its Phase III. The gov­ern­ment is re­port­ed­ly go­ing to of­fer two ex­per­i­men­tal can­di­dates from state-owned phar­ma con­glom­er­ate Sinopharm to em­ploy­ees of oth­er state-run com­pa­nies trav­el­ling over­seas.

Brazil is bat­tling a se­ri­ous coro­n­avirus out­break, top­ping the glob­al charts with over 30,000 new cas­es record­ed in a day.

— Am­ber Tong

As­traZeneca signs Emer­gent on for $87M man­u­fac­tur­ing deal

Hav­ing ne­go­ti­at­ed left and right to se­cure sup­ply of Ox­ford Uni­ver­si­ty’s Covid-19 vac­cine around the world, As­traZeneca has sealed a $87 mil­lion deal with a US man­u­fac­tur­ing part­ner.

Emer­gent BioSo­lu­tions al­ready ob­tained a meaty $628 mil­lion con­tract from BAR­DA to sup­port Op­er­a­tion Warp Speed, as well as a col­lab­o­ra­tion with J&J. With the new As­traZeneca pact, it now sup­ports “two of the five lead­ing can­di­dates be­ing de­vel­oped with U.S. gov­ern­ment fund­ing,” CEO Robert Kramer said.

The com­pa­ny will of­fer up its prod­uct de­vel­op­ment fa­cil­i­ty in Gaithers­burg, MD for de­vel­op­ment ser­vices, tech­nol­o­gy trans­fer, an­a­lyt­i­cal test­ing, drug sub­stance process and per­for­mance qual­i­fi­ca­tion. Large-scale man­u­fac­tur­ing ca­pac­i­ty will al­so be re­served at the Bal­ti­more Bayview site through 2020.

No­tably, with a ca­pac­i­ty to pro­duce tens to hun­dreds of mil­lions of dos­es every year, Emer­gent on­ly meets a frac­tion of the goal sketched out by com­pa­nies — with As­traZeneca out­lin­ing a goal for 2 bil­lion. — Am­ber Tong

Fol­low­ing Sino­vac, Chi­na’s Sinopharm posts pos­i­tive an­i­mal da­ta

Sinopharm has re­port­ed an­i­mal da­ta for one of two Covid-19 vac­cine can­di­dates its sub­sidiaries are test­ing in the clin­ic, spot­light­ing “high lev­els of neu­tral­iz­ing an­ti­bod­ies titers in mice, rats, guinea pigs, rab­bits and non­hu­man pri­mates.”

Like three oth­er Chi­nese can­di­dates cur­rent­ly in clin­i­cal test­ing, BBIBP-CorV is an in­ac­ti­vat­ed ver­sion of SARS-CoV-2.

All in all, the sci­en­tists re­port­ed in Cell, every­thing — in­clud­ing the ge­net­ic sta­bil­i­ty for man­u­fac­ture — sup­port­ed fur­ther eval­u­a­tion in the clin­ic. And eval­u­at­ed it is, with a mul­ti-arm Phase I/II tri­al on­go­ing.

Two-dose im­mu­niza­tions us­ing 2 μg/dose of BBIBP-CorV pro­vid­ed high­ly ef­fi­cient pro­tec­tion against SARS-CoV-2 in­tra­tra­cheal chal­lenge in rhe­sus macaques, with­out de­tectable an­ti­body-de­pen­dent en­hance­ment of in­fec­tion. — Am­ber Tong

Rus­sia to test ser­vice­men in race to get vac­cine ap­proved by Sep­tem­ber

Rus­sia is bar­rel­ing for­ward on a home­grown vac­cine race, with 10 can­di­dates in the pipeline, plans to test them on mil­i­tary re­cruits, and the po­ten­tial­ly dan­ger­ous goal  of hav­ing one ap­proved by Sep­tem­ber.

The Wall Street Jour­nal dove in­to the bristling ef­fort, as coro­n­avirus cas­es sur­pass 500,000 in a coun­try that once count­ed among the world’s top re­search hubs. Al­though Rus­sia lacks the biotech and phar­ma base that have made the UK, US and Chi­na home to the world’s lead­ing vac­cine ef­forts, the coun­try’s race bears pass­ing sim­i­lar­i­ties to pro­grams, such as Op­er­a­tion Warp Speed, where­by gov­ern­ments try to se­cure their cit­i­zens ac­cess to the first vac­cines avail­able.

Pres­i­dent Vladimir Putin has in­sist­ed on an ap­proval by Sep­tem­ber, in line when As­traZeneca may be­gin de­liv­er­ing vac­cines to the UK. It’s un­clear, though, if the coun­try plans on the kind of large-scale test­ing As­traZeneca, in part­ner­ship with the US gov­ern­ment, has al­ready set in­to mo­tion and which is nec­es­sary to test not on­ly a vac­cine’s ef­fi­ca­cy, but al­so its safe­ty.

Rus­sia has 10 can­di­dates, the fourth most of any coun­try, be­hind the US, Chi­na and Cana­da, ac­cord­ing to the WHO. Last week, the Russ­ian mil­i­tary iso­lat­ed 45 men and 5 women from the mil­i­tary, who will then be giv­en a vac­cine de­vel­oped by the min­istries of de­fense and health. Clin­i­cal re­search for that vac­cine is sched­uled to be com­plet­ed by Ju­ly, ac­cord­ing to WSJ.

An­oth­er vac­cine will soon be­gin test­ing on paid vol­un­teers at the In­sti­tute for Trans­la­tion­al Med­i­cine and Biotech­nol­o­gy at Sechen­ov Uni­ver­si­ty. A third is un­der­way at the St. Pe­ters­burg In­sti­tute for Ex­per­i­men­tal Med­i­cine. That one in­volves a coro­n­avirus gene de­liv­ered via pro­bi­ot­ic bac­te­ria in yo­gurt. — Ja­son Mast

Equipped with €2.7B fund, EU eyes BAR­DA-style deals with vac­cine de­vel­op­ers

The Eu­ro­pean Union will be pri­or­i­tiz­ing com­pa­nies with man­u­fac­tur­ing ca­pac­i­ty out­side of the US as it gears up to ink ad­vance pur­chase deals with de­vel­op­ers of Covid-19 vac­cines with a €2.7 bil­lion emer­gency fund.

EU health min­is­ters will dis­cuss the strat­e­gy to­day, the Fi­nan­cial Times wrote, echo­ing a pre­vi­ous Reuters re­port. By hand­ing over mil­lions to mul­ti­ple phar­ma com­pa­nies — some­times be­fore clin­i­cal tri­als even start — the goal is to se­cure ac­cess to one or more that’s even­tu­al­ly proven to work.

“Every month gained in the de­ploy­ment of a vac­cine will save many lives, many jobs and many bil­lions of eu­ros,” read a doc­u­ment re­viewed by the FT.

Sanofi CEO Paul Hud­son height­ened con­cerns about so-called “vac­cine na­tion­al­ism” when he said in an in­ter­view that the US will have the right to the largest pre-or­der of the French drug­mak­er’s vac­cines — due to its gen­er­ous fi­nan­cial sup­port at-risk. Ethi­cists and non-gov­ern­men­tal or­ga­ni­za­tions fear that politi­cians will fight for cov­et­ed vac­cines at the per­il of poor­er and more vul­ner­a­ble coun­tries.

On their part, vac­cine de­vel­op­ers have most­ly vowed to strive for eq­ui­table ac­cess. As­traZeneca has struck deals to pro­vide the Ox­ford vac­cine to low- and mid­dle-in­come coun­tries even as it signed sup­ply com­mit­ments with the US and the UK.

The new EU ini­tia­tive will be look­ing for projects that are ready for mass pro­duc­tion in 2021.

“Lo­ca­tion is im­por­tant, tim­ing is im­por­tant and the solid­ness of the sci­en­tif­ic ap­proach is im­por­tant,” an of­fi­cial told the pa­per. “We need to make sure we are bet­ting on can­di­dates that have a good chance of be­ing suc­cess­ful.” — Am­ber Tong

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

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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