Covid-19 roundup: With ef­fi­ca­cy da­ta in hand, BioN­Tech talks pric­ing; Brazil halts Sino­vac tri­al fol­low­ing pa­tient death

On the heels of be­com­ing the first to re­lease Phase III ef­fi­ca­cy da­ta for the Covid-19 vac­cine it de­vel­oped with Pfiz­er, BioN­Tech is now talk­ing pric­ing.

Ryan Richard­son

BioN­Tech CSO Ryan Richard­son said at a Fi­nan­cial Times vir­tu­al event that the com­pa­ny is aim­ing to set a price point be­low “typ­i­cal mar­ket rate” for its two-shot vac­cine, per Reuters. The firm al­so ex­pects the price will be dif­fer­ent de­pend­ing on the coun­try or re­gion in which it’s sold, though Richard­son did not elab­o­rate.

Richard­son added that what­ev­er the price ends up be­ing, it will re­flect the fi­nan­cial risks in­curred by the com­pa­ny’s pri­vate-sec­tor in­vestors.

“We’ve tried to pur­sue a bal­anced ap­proach that rec­og­nizes that in­no­va­tion re­quires cap­i­tal and in­vest­ment so we plan to price our vac­cine well be­low typ­i­cal mar­ket rates re­flect­ing the sit­u­a­tion that we’re in and with the goal to en­sure broad-based ac­cess around the world,” Richard­son said at the FT event, ac­cord­ing to Reuters. 

The two com­pa­nies re­leased the first look at their late-stage vac­cine da­ta Mon­day, say­ing that the can­di­date is more than 90% ef­fec­tive af­ter an analy­sis of 94 con­firmed Covid-19 cas­es. The Phase III tri­al has en­rolled near­ly 44,000 vol­un­teers thus far, and an EUA could be on the hori­zon once the safe­ty da­ta are ex­pect­ed to come in lat­er this month.

In Ju­ly, Pfiz­er agreed to sell 100 mil­lion dos­es of the vac­cine to the US for $1.9 bil­lion, putting the price of a two-dose reg­i­men at $39 per pa­tient. And over the last sev­er­al months, BioN­Tech has re­ceived €100 mil­lion from the EU’s fi­nan­cial arm and €375 mil­lion from the Ger­man gov­ern­ment to de­vel­op the vac­cine. — Max Gel­man

Sino­vac vac­cine tri­al halt­ed in Brazil af­ter pa­tient death

A se­ri­ous ad­verse event has spurred Brazil’s health reg­u­la­tor to halt a Phase III tri­al of Sino­vac’s coro­n­avirus vac­cine can­di­date — the first such set­back so far for any Chi­nese de­vel­op­ers.

Di­mas Co­vas

An­visa an­nounced the move on its web­site Mon­day morn­ing, sur­pris­ing the Bu­tan­tan In­sti­tute, the state-run bio­med­ical re­search in­sti­tute in São Paulo that is con­duct­ing the tri­al. The de­ci­sion was re­lat­ed to the death of a vol­un­teer in the tri­al, ac­cord­ing to lo­cal me­dia re­ports. Bu­tan­tan head Di­mas Co­vas said on TV that he found the de­ci­sion to sus­pend dos­ing strange be­cause the death was deemed un­re­lat­ed to the vac­cine.

“As there are more than 10,000 vol­un­teers at this mo­ment, deaths can oc­cur … It’s a death that has no re­la­tion with the vac­cine and as such it is not the mo­ment to in­ter­rupt the tri­als,” Co­vas told lo­cal broad­cast­er TV Cul­tura, as quot­ed by Reuters.

In its state­ment, An­visa not­ed that it was no­ti­fied of the “event” (it didn’t spec­i­fy) on Oct. 29, and now wants to eval­u­ate the ben­e­fits and risks be­fore de­cid­ing whether the tri­al should con­tin­ue.

Echo­ing the mes­sag­ing from the US and the UK when they hit the brakes on As­traZeneca and J&J’s tri­als, the Brazil­ian agency not­ed in­ter­rup­tions to guar­an­tee safe­ty are all part of the stan­dard prac­tice.

“Sino­vac will con­tin­ue to com­mu­ni­cate with Brazil on this mat­ter,” the com­pa­ny wrote in a state­ment. “The clin­i­cal study in Brazil is strict­ly car­ried out in ac­cor­dance with GCP re­quire­ments and we are con­fi­dent in the safe­ty of the vac­cine.”

Sino­vac and Bu­tan­tan had planned on test­ing a two-dose reg­i­men of its in­ac­ti­vat­ed virus vac­cine, Coro­n­aVac, on 13,000 vol­un­teers in Brazil. It’s al­so run­ning late-stage tri­als in Turkey and In­done­sia.

But 3,000 of Sino­vac’s own em­ploy­ees — in­clud­ing its CEO — have re­ceived the vac­cine out­side of clin­i­cal tri­als. Fol­low­ing an emer­gency use au­tho­riza­tion based on Phase I/II da­ta, es­sen­tial work­ers and oth­er high-risk groups such as stu­dents trav­el­ing over­seas can al­so get vac­ci­nat­ed for about $60.

In what’s been de­scribed as vac­cine diplo­ma­cy, the Chi­nese gov­ern­ment has pledged that any made-in-Chi­na vac­cine would be a glob­al pub­lic good and promised pri­or­i­ty ac­cess for coun­tries that host­ed late-stage clin­i­cal tri­als.

Sino­vac is sup­posed to send 6 mil­lion dos­es of its vac­cines to Brazil, Reuters re­port­ed. Hours be­fore the news of the clin­i­cal hold dropped, the state of São Paulo tout­ed the con­struc­tion of a $26.5 mil­lion fa­cil­i­ty that would man­u­fac­ture 100 mil­lion dos­es of Coro­n­aVac per year. The site is ex­pect­ed to come on­line by next Sep­tem­ber. — Am­ber Tong

Am­gen and Ei­sai join study fa­cil­i­tat­ed by ar­ti­fi­cial in­tel­li­gence

Two promi­nent drug­mak­ers are join­ing a new kind of study for Covid-19 treat­ments that us­es ar­ti­fi­cial in­tel­li­gence.

Am­gen and Ei­sai have signed on to REMAP-CAP, eval­u­at­ing their ex­per­i­men­tal drugs in a glob­al adap­tive tri­al where an AI will rapid­ly com­pare treat­ments for the dis­ease. The type of AI in­volved in the study, called re­in­force­ment learn­ing, is able to ad­just treat­ment pro­to­cols based on how dif­fer­ent ther­a­pies af­fect pa­tient out­comes.

Run­ning the tri­al will be the Uni­ver­si­ty of Pitts­burgh Med­ical School. The two com­pa­nies are the first in the phar­ma in­dus­try to join the study.

Am­gen’s apremi­last in­hibits the ac­tiv­i­ty of an en­zyme found in in­flam­ma­to­ry cells in the hu­man body, mod­u­lat­ing the pro­duc­tion of in­flam­ma­to­ry cy­tokines and oth­er me­di­a­tors in some Covid-19 pa­tients. The drug is cur­rent­ly ap­proved in 45 coun­tries to treat in­flam­ma­to­ry dis­ease like plaque pso­ri­a­sis and pso­ri­at­ic arthri­tis.

Ei­sai’s Er­i­toran is an in­ves­ti­ga­tion­al TLR4 an­tag­o­nist that had been de­vel­oped for se­vere sep­sis, where it was found to be safe in a Phase III study. The com­pa­ny hopes the can­di­date can sup­press in­flam­ma­tion caused by Covid-19 by in­hibit­ing the ac­ti­va­tion of TLR4. — Max Gel­man

Cana­di­an biotech Med­ica­go says its vac­cine pro­duced a 100% an­ti­body re­sponse in PhI

Med­ica­go, a Cana­di­an biotech backed by Philip Mor­ris, has re­port­ed pos­i­tive Phase I da­ta from its Covid-19 vac­cine de­vel­oped from to­bac­co leaves.

Af­ter re­ceiv­ing two dos­es of the ad­ju­vant­ed vac­cine, 100% of pa­tients reg­is­tered an­ti­body re­spons­es, the com­pa­ny said in a press re­lease Tues­day. In a preprint of the study, al­so pub­lished Tues­day, the vac­cine re­port­ed­ly did not cause any se­vere side ef­fects.

The tri­al it­self eval­u­at­ed three dosage lev­els in the 180 pa­tients. Med­ica­go stud­ied drug arms of 3.75 μg, 7.5 μg and 15 μg us­ing ei­ther its virus-like par­ti­cle-based vac­cine alone or with one of two ad­ju­vants from GSK and Dy­navax. Even at the low­est ad­ju­vant­ed dose, neu­tral­iz­ing an­ti­body titers were 10 times high­er than those found in the blood of pa­tients who re­cov­ered from Covid-19 on their own.

Ad­di­tion­al­ly, all pa­tients in the group with GSK’s ad­ju­vant de­vel­oped an­ti-spike IgG an­ti­bod­ies af­ter a sin­gle dose of the vac­cine, at all dosage lev­els. Med­ica­go al­so says its vac­cine can­di­date can be stored at tem­per­a­tures above freez­ing — be­tween 2 and 8 de­grees Cel­sius.

With the re­sults, Med­ica­go plans to move in­to a Phase II/III tri­al some­time soon, though they didn’t spec­i­fy ex­act­ly when. The com­pa­ny said that the da­ta sup­ports tak­ing the low­est dose in­to fur­ther tri­als, but it wasn’t im­me­di­ate­ly clear that’s what it plans to do.

Med­ica­go has pre­vi­ous­ly said it could make up to 100 mil­lion dos­es of its vac­cine can­di­date in 2021. The biotech ranks 9th in End­points News’ Covid-19 vac­cine race track­er. — Max Gel­man

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

Biogen CEO Michel Vounatsos (via Getty Images)

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

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With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

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Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

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The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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