Anthony Fauci, NIAID director (AP Images)

Covid-19 roundup: Fau­ci says first graders could have ac­cess to vac­cine by Sep­tem­ber — re­port; EMA be­gins rolling re­view of Cure­Vac vac­cine

NI­AID di­rec­tor An­tho­ny Fau­ci says kids as young as first grade could be el­i­gi­ble for Covid-19 vac­cines by the time school starts in Sep­tem­ber, per Prop­ub­li­ca. 

Fau­ci told Prop­ub­li­ca that age de-es­ca­la­tion tri­als are un­der­way to prove vac­cines are safe and ef­fec­tive in chil­dren. “I would think by the time we get to school open­ing, we like­ly will be able to get peo­ple who come in­to the first grade,” he said.

Pfiz­er and BioN­Tech have com­plet­ed en­roll­ment in a study with 12- to 15 year-olds, and ex­pect to read out da­ta ear­ly this year, a spokesper­son told the news or­ga­ni­za­tion. Then it’ll fi­nal­ize a study in 5- to 11-year-olds. Mod­er­na, on the oth­er hand, is still en­rolling par­tic­i­pants in its tri­al for kids 12 to 18 years old, and doesn’t ex­pect da­ta un­til mid-2021, the biotech said in an emailed state­ment to Prop­ub­li­ca.

John­son & John­son, which sub­mit­ted an EUA ap­pli­ca­tion for its one-shot vac­cine last week, an­nounced plans in Oc­to­ber to be­gin test­ing ado­les­cents ages 12 to 18 “as soon as pos­si­ble,” In­sid­er re­port­ed. But ac­cord­ing to Prop­ub­li­ca, the com­pa­ny has yet to be­gin ado­les­cent tri­als.

Pfiz­er’s vac­cine has been au­tho­rized for peo­ple 16 years and old­er, while Mod­er­na’s shot was au­tho­rized for those 18 and old­er. Mod­er­na an­nounced the first pa­tients were dosed in its Phase II/III ado­les­cent study on Dec. 10, which is en­rolling 3,000 pa­tients in the US.

Ac­cord­ing to Mod­er­na, ef­fec­tive­ness will be mea­sured by “achiev­ing a cor­re­late of pro­tec­tion (if es­tab­lished) or through im­muno­bridg­ing to the adult pop­u­la­tion.” The kids will be giv­en ei­ther two vac­cine or place­bo dos­es 28 days apart, and will be mon­i­tored for 12 months af­ter the sec­ond shot. — Nicole De­Feud­is 

EMA be­gins rolling re­view of Cure­Vac vac­cine

The EMA has be­gun a rolling re­view of Cure­Vac’s mR­NA vac­cine, the agency an­nounced on Fri­day.

Franz-Wern­er Haas

This means the agency’s hu­man med­i­cines com­mit­tee has be­gun eval­u­at­ing pre­lim­i­nary re­sults from ear­ly clin­i­cal stud­ies. The rolling re­view process con­tin­ues un­til the agency has all the ev­i­dence it needs to sup­port po­ten­tial mar­ket­ing au­tho­riza­tion.

Cure­Vac dosed the first pa­tient in a Phase IIb/III study in mid-De­cem­ber, putting the com­pa­ny well be­hind an am­bi­tious time­line that CEO Franz-Wern­er Haas laid out in Au­gust. Haas ini­tial­ly planned to kick off a piv­otal Phase III by the end of 2020, and read out da­ta that could be used to ap­proach reg­u­la­tors in Q1 2021. On Dec. 21, Cure­Vac an­nounced it was launch­ing a Phase III tri­al in health­care work­ers, to run in par­al­lel to the glob­al Phase IIb/III tri­al.

Ear­li­er this year, Bay­er and Cure­Vac en­tered in­to a “col­lab­o­ra­tion and ser­vices agreement” for the vac­cine, giv­ing Bay­er re­spon­si­bil­i­ty for some de­vel­op­ment, sup­ply and key ter­ri­to­ry op­er­a­tions.

“We are high­ly com­mit­ted to mak­ing our ca­pa­bil­i­ties and net­works avail­able to help end this pan­dem­ic,” Ste­fan Oel­rich, pres­i­dent of the phar­ma di­vi­sion, said in a state­ment. — Nicole De­Feud­is 

Pfiz­er/BioN­Tech vac­cine rec­om­mend­ed for ap­proval in Japan

Pfiz­er and BioN­Tech are lined up to get their Covid-19 shot ap­proved for use in Japan.

A Japan­ese pan­el gave the mR­NA shot the OK on Fri­day night, ac­cord­ing to Reuters. The gov­ern­ment could give its for­mal — and first — ap­proval by Sun­day, the news agency re­port­ed.

The coun­try pur­chased 144 mil­lion dos­es of Pfiz­er/BioN­Tech’s vac­cine, the first of which ar­rived on Fri­day, ac­cord­ing to The Japan Times. About 400,000 dos­es were de­liv­ered to Nari­ta Air­port east of Tokyo, ac­cord­ing to the pa­per.

The 144 mil­lion dos­es would have been enough to in­noc­u­late 72 mil­lion peo­ple. But af­ter Pfiz­er changed its la­bel to ac­count for six dos­es per vial in­stead of five, Japan wor­ries it won’t be able to stretch the sup­ply as far. A spe­cial sy­ringe is nec­es­sary to ex­tract the sixth dose, which is in short sup­ply across the coun­try. The Japan­ese gov­ern­ment put out a re­quest ear­li­er this week that man­u­fac­tur­ers boost pro­duc­tion of the sy­ringes, the Times re­port­ed. — Nicole De­Feud­is 

US inks deal for 200M more vac­cine dos­es from Pfiz­er, Mod­er­na

As vac­cine roll­out in the US con­tin­ues to lag be­hind sched­ule, Pres­i­dent Joe Biden told re­porters that his ad­min­is­tra­tion bought 200 mil­lion more shots — 100 mil­lion from each Pfiz­er/BioN­Tech and Mod­er­na, which are sched­uled to ar­rive by the end of Ju­ly.

Biden made use of op­tions built in­to ex­ist­ing con­tracts with the com­pa­nies, ac­cord­ing to the Wash­ing­ton Post. Pfiz­er and Mod­er­na were al­ready on the hook for 400 mil­lion dos­es to the US, and Biden said there’d be enough sup­ply to ful­ly vac­ci­nate 200 mil­lion peo­ple by the end of May, the Post re­port­ed.

In a state­ment, Mod­er­na said it has al­ready com­mit­ted to or­ders to­tal­ing 631.5 mil­lion dos­es, 300 mil­lion of which it promised to the US. The EU has pur­chased 160 mil­lion dos­es, and Cana­da 40 mil­lion. So far, over 41 mil­lion have al­ready been sup­plied to the US.

Stéphane Ban­cel

“We con­tin­ue to scale up our man­u­fac­tur­ing ca­pa­bil­i­ty, both in and out­side of the Unit­ed States,” CEO Stéphane Ban­cel said in a state­ment. “It is en­cour­ag­ing and hum­bling to know that more than 22 mil­lion Amer­i­cans have al­ready been pro­tect­ed with Mod­er­na’s vac­cine,” he added lat­er.

Mod­er­na says it re­mains on track to de­liv­er the first 100 dos­es to the US in this quar­ter, with the next 100 mil­lion com­ing in May. The Cam­bridge, MA-based biotech set a goal to de­liv­er the last 100 mil­lion by the end of Ju­ly.

Biden said last week that his ad­min­is­tra­tion was tak­ing sev­er­al steps un­der the De­fense Pro­duc­tion Act to make sure Pfiz­er has all the equip­ment it needs to boost man­u­fac­tur­ing.

So far, just over 46 mil­lion dos­es have been ad­min­is­tered in the US, ac­cord­ing to the CDC. And more than 68 mil­lion shots have been de­liv­ered.

John­son & John­son filed for emer­gency use au­tho­riza­tion of its jab last week, though its shot is no­tably less ef­fec­tive than the al­ready ap­proved ones from Pfiz­er and Mod­er­na. J&J said its shot was 66% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19, and 85% ef­fec­tive at pre­vent­ing se­vere dis­ease. In South Africa, where the B.1.351 has be­come com­mon, the vac­cine was 55% ef­fec­tive. — Nicole De­Feud­is 

Roche’s Actem­ra cuts risk of death in large tri­al — time to re­deem IL-6?

The IL-6 the­o­ry is mak­ing an­oth­er come­back in Covid-19.

Once marred by dis­ap­point­ing Phase III re­sults on pa­tients with ear­ly-stage Covid-19 pneu­mo­nia, Roche’s Actem­ra re­deemed it­self by cut­ting the risk of death in RE­COV­ERY, the UK-based tri­al that’s ce­ment­ed sev­er­al drugs’ role as stan­dard of care in treat­ing coro­n­avirus in­fec­tion.

In­ves­ti­ga­tors ac­knowl­edged that pre­vi­ous tri­als of Actem­ra, or tocilizum­ab, yield­ed mixed re­sults and on­ly weak ev­i­dence that it could short­en time to dis­charge or re­duce pro­gres­sion to in­va­sive me­chan­i­cal ven­ti­la­tion or death. But they em­pha­sized that their tri­al had a larg­er and more di­verse sam­ple size.

And the find­ings — gath­ered from 4116 hos­pi­tal­ized pa­tients — were sig­nif­i­cant, they wrote in a preprint:

Over­all, 596 (29%) of the 2022 pa­tients al­lo­cat­ed tocilizum­ab and 694 (33%) of the 2094 pa­tients al­lo­cat­ed to usu­al care died with­in 28 days (rate ra­tio 0.86; 95% con­fi­dence in­ter­val [CI] 0.77-0.96; p=0.007). Con­sis­tent re­sults were seen in all pre-spec­i­fied sub­groups of pa­tients, in­clud­ing those re­ceiv­ing sys­temic cor­ti­cos­teroids. Pa­tients al­lo­cat­ed to tocilizum­ab were more like­ly to be dis­charged from hos­pi­tal alive with­in 28 days (54% vs. 47%; rate ra­tio 1.23; 95% CI 1.12-1.34; p<0.0001). Among those not re­ceiv­ing in­va­sive me­chan­i­cal ven­ti­la­tion at base­line, pa­tients al­lo­cat­ed tocilizum­ab were less like­ly to reach the com­pos­ite end­point of in­va­sive me­chan­i­cal ven­ti­la­tion or death (33% vs. 38%; risk ra­tio 0.85; 95% CI 0.78-0.93; p=0.0005).

With a dif­fer­ence in mor­tal­i­ty of 4%, they ex­trap­o­lat­ed that for every 25 pa­tients treat­ed with Actem­ra, one ad­di­tion­al life would be saved.

The re­sults echo what Roche found in a small­er study where pa­tients with Covid-as­so­ci­at­ed pneu­mo­nia who took Actem­ra were 44% less like­ly to need mech­a­nism ven­ti­la­tion or die down the road, com­pared to the place­bo arm (p-val­ue = 0.0348).

In par­tic­u­lar, RE­COV­ERY joint chief in­ves­ti­ga­tor Pe­ter Horn­by not­ed, all pa­tients with low oxy­gen lev­els and sig­nif­i­cant in­flam­ma­tion stand to ben­e­fit.

Mar­tin Lan­dray, his coun­ter­part, added that the tri­al re­sults show Actem­ra with dex­am­etha­sone — a cor­ti­cos­teroid they’ve pre­vi­ous­ly shown to re­duce mor­tal­i­ty — can help tack­le the worst con­se­quences of Covid-19.

“Used in com­bi­na­tion, the im­pact is sub­stan­tial,” he said in a state­ment. “This is good news for pa­tients and good news for the health ser­vices that care for them in the UK and around the world.” — 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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