Covid-19 roundup: South Africa con­sid­ers sell­ing or swap­ping As­traZeneca shots; Chi­na calls for WHO probe in US

Two days af­ter halt­ing the coun­try’s roll­out of As­traZeneca and Ox­ford Uni­ver­si­ty’s Covid-19 vac­cine, the South Africa gov­ern­ment said it is con­sid­er­ing sell­ing or ex­chang­ing the dos­es it’s al­ready re­ceived.

One mil­lion shots ar­rived in the coun­try last week, and an­oth­er 500,000 are ex­pect­ed to come in the near fu­ture. Of­fi­cials will ul­ti­mate­ly wait to make their de­ci­sion un­til af­ter they hear from sci­en­tif­ic ex­perts, and in the mean­time are prepar­ing to launch a study in health work­ers for J&J’s vac­cine, health min­is­ter Zweli Mkhize said at a news con­fer­ence, per Reuters.

“Why not sell the As­traZeneca to oth­er coun­tries, well it’s an op­tion … we will con­sid­er it,” Mkhize said. “First our sci­en­tists will tell us what we do with it, can we use it with­in the time that’s avail­able … be­fore it ex­pires.”

It’s not yet clear whether As­traZeneca would be OK with such a move, or how ex­act­ly a vac­cine ex­change might work.

The coun­try has pre­vi­ous­ly said it has pur­chased 9 mil­lion dos­es of J&J’s sin­gle-shot vac­cine, and is still in ne­go­ti­a­tions to ac­quire the Mod­er­na, Sinopharm and Sput­nik V jabs. In the South African por­tion of the com­pa­ny’s tri­al, the J&J vac­cine was 89% ef­fec­tive at pre­vent­ing se­vere dis­ease and 57% against mod­er­ate-to-se­vere dis­ease.

South Africa stopped the As­traZeneca dis­tri­b­u­tion af­ter da­ta from a small clin­i­cal tri­al in­di­cat­ed the shot was not ef­fec­tive against mild and mod­er­ate Covid-19 cas­es caused by the new vari­ant that first emerged in the coun­try. The strain is now dom­i­nant, with stud­ies from No­vavax and J&J in the coun­try sug­gest­ing it now makes up more than 90% of cas­es.

Reuters re­port­ed ear­li­er this week that pri­or to the spread of the vari­ant, As­traZeneca’s vac­cine was show­ing an ef­fi­ca­cy of around 75%. But in an­oth­er analy­sis based most­ly on in­fec­tions by the new vari­ant, the ef­fi­ca­cy rate was about 22%.

And in a study of on­ly those in­fect­ed by the new vari­ant, there was ef­fec­tive­ly no dif­fer­ence in the num­ber of cas­es in the place­bo group and the vac­cine group.

Chi­na ratch­ets up rhetoric, calls for virus ori­gins probe in US

One day af­ter the WHO com­plet­ed its probe in Chi­na in­to the ori­gins of the Covid-19 pan­dem­ic, all but rul­ing out the pos­si­bil­i­ty that the virus first emerged in a Wuhan lab, the Chi­nese gov­ern­ment con­tin­ued push­ing a the­o­ry that it first orig­i­nat­ed out­side its bor­ders.

Chi­na nee­dled the US over the in­ves­ti­ga­tion on Wednes­day, call­ing on the coun­try to in­vite WHO re­searchers to con­duct a sep­a­rate in­quiry in­to Covid-19 be­gin­nings on Amer­i­can soil, Reuters re­port­ed. US of­fi­cials had said ear­li­er Tues­day that they want to in­de­pen­dent­ly scru­ti­nize da­ta used by the team from the Wuhan probe.

Led by Pe­ter Ben Em­barek, the WHO team said Tues­day it was “ex­treme­ly un­like­ly” that the nov­el coro­n­avirus came from the re­sult of a lab ac­ci­dent, con­firm­ing what most health ex­perts had said since it first emerged in late 2019. He al­so raised the pos­si­bil­i­ty that frozen food pack­ag­ing could be a means of trans­mit­ting the virus. Chi­na has blamed some clus­ters of out­breaks on im­port­ed food.

The WHO probe all but swat­ted down the lab ac­ci­dent the­o­ry that had been pro­mot­ed at times by for­mer Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion, among oth­ers. Chi­na on Wednes­day called out for­mer Sec­re­tary of State Mike Pom­peo, with a state-run news­pa­per say­ing the team’s con­clu­sion “com­plete­ly re­futes the con­spir­a­cy the­o­ry” of a lab ac­ci­dent, per Reuters

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

So­cial: Elz­bi­eta Krzysztof / Shut­ter­stock

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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