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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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