Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

An­oth­er Big Phar­ma is en­ter­ing the Covid-19 an­ti­body hunt.

Ab­b­Vie has an­nounced a col­lab­o­ra­tion with the Nether­lands’ Utrecht Uni­ver­si­ty and Eras­mus Med­ical Cen­ter and the Chi­nese-Dutch biotech Har­bour Bio­med to de­vel­op a neu­tral­iz­ing an­ti­body that can treat Covid-19. The an­ti­body, called 47D11, was dis­cov­ered by Ab­b­Vie’s three part­ners, and Ab­b­Vie will sup­port ear­ly pre­clin­i­cal work, while prepar­ing for lat­er pre­clin­i­cal and clin­i­cal de­vel­op­ment. Re­searchers de­scribed the an­ti­body in Na­ture Com­mu­ni­ca­tions last month.

Al­though ear­ly in the out­break, Ab­b­Vie con­tributed its HIV an­tivi­ral cock­tail Kale­tra to clin­i­cal tri­als, this is the drug com­pa­ny’s first for­ay in­to de­vel­op­ing new treat­ments for the nov­el virus. Al­though the Illi­nois-based phar­ma has lit­tle ap­par­ent ex­pe­ri­ence in de­vel­op­ing an­ti­bod­ies for virus­es, much of their com­mer­cial and re­search work cen­ters on an­ti­bod­ies, in­clud­ing with the block­buster TNF-block­ing an­ti­body Hu­mi­ra.

Last Au­gust, an NIH-fund­ed clin­i­cal tri­al found two dif­fer­ent an­ti­body treat­ments to be the first and on­ly ef­fec­tive treat­ments for Ebo­la, and when the new coro­n­avirus emerged in De­cem­ber, re­searchers jumped in ear­ly to be­gin de­vel­op­ing an­ti­bod­ies for it. Most promi­nent­ly, Re­gen­eron, which de­vel­oped one of the ef­fec­tive Ebo­la treat­ments, and Vir, which owns the plat­form that helped de­vel­op the oth­er one, an­nounced pro­grams in late Jan­u­ary and ear­ly Feb­ru­ary.

Ab­Cellera, a com­pa­ny known for help­ing Big Phar­ma and ma­jor biotechs de­vel­op their an­ti­bod­ies, then fol­lowed up with a pro­gram in part­ner­ship with Eli Lil­ly. Ear­li­er this week, that pro­gram was the first to en­ter clin­i­cal tri­als, al­though Vir and Re­gen­eron are each ex­pect­ed to start their own pro­grams short­ly. David Ho, the renowned HIV re­searcher and Co­lum­bia Uni­ver­si­ty pro­fes­sor, is work­ing on his own an­ti­body project, as are a long list of oth­er re­searchers and small biotechs.

Neu­tral­iz­ing an­ti­bod­ies are a part of the body’s nat­ur­al re­sponse to in­fec­tion, as B cells cre­ate mol­e­cules that match re­cep­tors on the virus and, ide­al­ly, block its abil­i­ty to en­ter cells while re­cruit­ing oth­er im­mune cells to at­tack. That process though can take days or weeks, dur­ing which time the in­fec­tion can spread. Over the last few decades, re­searchers have de­vel­oped pro­grams to cre­ate these an­ti­bod­ies ar­ti­fi­cial­ly through trans­genic mice or by ex­tract­ing them from the blood of sur­vivors. You can then give them to pa­tients as a treat­ment or a pre­ven­ta­tive mea­sure.

Cre­at­ing a can­di­date an­ti­body, though, is on­ly step one, and the one that Ab­b­Vie has part­nered on still has sig­nif­i­cant steps to take. The com­pa­ny holds an op­tion to li­cense for com­mer­cial and clin­i­cal de­vel­op­ment. — Ja­son Mast

As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

For­get 1 bil­lion. As­traZeneca is now promis­ing to sup­ply 2 bil­lion dos­es of Ox­ford Uni­ver­si­ty’s Covid-19 vac­cine around the world per year.

Three new part­ners are com­ing on board to help reach that goal, as well as a broad­er vi­sion to en­sure ac­cess for na­tions that have been large­ly left out of the bar­gain­ing ta­ble.

CEPI — the coali­tion that’s been dol­ing out grants to sup­port oth­er vac­cine projects — is pro­vid­ing $383 mil­lion to sup­port man­u­fac­tur­ing of 300 mil­lion dos­es, while Gavi the Vac­cine Al­liance will chip in $367 mil­lion and be in charge of the pro­cure­ment and dis­tri­b­u­tion, a spokesper­son told Wall Street Jour­nal. A sep­a­rate li­cens­ing agree­ment di­rects the Serum In­sti­tute of In­dia to pro­duce 1 bil­lion dos­es for low- and mid­dle-in­come coun­tries, with the first 400 mil­lion due be­fore the end of the year.

As­traZeneca CEO Pas­cal So­ri­ot stressed in a state­ment that the vac­cines will be pro­vid­ed “at no prof­it” dur­ing the pan­dem­ic.

The al­lo­ca­tion of vac­cines has be­come a top con­cern as gov­ern­ments scram­ble to se­cure first dibs for their cit­i­zens, trig­ger­ing fears that peo­ple in poor­er coun­tries — pop­u­la­tions who are most vul­ner­a­ble to out­breaks — will be left out.

Ox­ford re­searchers al­so ap­pear to be keep­ing that in mind as they or­ga­nize the clin­i­cal tri­als, an­nounc­ing to­day that Brazil­ian health au­thor­i­ties have cleared an ap­pli­ca­tion to in­clude Brazil in the Phase III tri­al of the re­com­bi­nant ade­n­ovirus vac­cine can­di­date.

The uni­ver­si­ty has be­gun re­cruit­ing 10,000 par­tic­i­pants in the UK while As­traZeneca en­rolls 30,000 in the US. For Brazil, the goal is to test the vac­cine in 2,000 vol­un­teers.

“Brazil is a pri­or­i­ty for the study be­cause of the as­cen­dant curve of the COVID-19,” they wrote. — Am­ber Tong

CSL com­mits to fund­ing, man­u­fac­tur­ing Aus­tralian vac­cine can­di­date

Aus­tralian phar­ma gi­ant CSL is throw­ing its weight be­hind a Covid-19 vac­cine de­vel­oped at the Uni­ver­si­ty of Queens­land, help­ing fund the de­vel­op­ment and sign­ing up as the man­u­fac­tur­er.

UQ re­searchers are work­ing with a “mol­e­c­u­lar clamp” en­abled vac­cine, whose core idea is to “lock” the un­sta­ble, pre­fu­sion ver­sion of the sur­face pro­teins on en­veloped virus to gen­er­ate syn­thet­ic pro­teins that can elic­it a more ef­fi­cient im­mune re­sponse. They have been ex­per­i­ment­ing with a cou­ple of ad­ju­vants, one from GSK and an­oth­er pro­vid­ed by CSL sub­sidiary Se­qirus.

To­geth­er with CEPI — which had backed the tech­nol­o­gy plat­form with a $10.6 mil­lion grant in ear­ly 2019, and lat­er came back to fund a Covid-19 project — CSL will sup­port the up­com­ing Phase I safe­ty study as well as lat­er-stage tri­als.

They will al­so prep their fa­cil­i­ties in Mel­bourne for large-scale man­u­fac­tur­ing. Should the vac­cine be proven ef­fec­tive, they ex­pect to scale the pro­duc­tion to 100 mil­lion dos­es to­ward the end of 2021, while sub­con­tract­ing out to oth­er CMOs around the world.

“We’ll go as fast as we can, we’re em­pha­sis­ing it is a high-risk project,” CSO An­drew Cuth­bert­son told the Syd­ney Morn­ing Her­ald. — Am­ber Tong

Lancet, NE­JM re­trac­tions height­en scan­dal around pa­pers tied to con­tro­ver­sial da­ta an­a­lyt­ics firm

In the world of aca­d­e­m­ic re­search, the coro­n­avirus cri­sis has glo­ri­fied the adage: Shoot first, ask ques­tions lat­er.

Sci­en­tists, des­per­ate to sep­a­rate the wheat from the chaff to has­ten the search for a vi­able ther­a­peu­tic, have been lean­ing heav­i­ly on preprint servers to vault their find­ings in­to the pub­lic sphere even be­fore their peers have a chance to re­view their work. But now, the first big re­search ca­su­al­ty of the cri­sis has emerged from two pres­ti­gious med­ical jour­nals.

It all start­ed with a May 22 pa­per in the Lancet, which de­pict­ed the re­sults of a large ret­ro­spec­tive study on 96,000 Covid-19 pa­tients, us­ing hos­pi­tal records pro­cured by a lit­tle-known da­ta an­a­lyt­ics com­pa­ny Sur­gi­sphere. The con­clu­sion — that coro­n­avirus pa­tients tak­ing chloro­quine or hy­drox­y­chloro­quine were more like­ly to ex­pe­ri­ence ir­reg­u­lar heart rhythms and were more like­ly to die — erod­ed al­ready wan­ing sci­en­tif­ic in­ter­est in the malar­ia ther­a­pies cham­pi­oned by Pres­i­dent Don­ald Trump to such a de­gree that a num­ber of key ran­dom­ized, place­bo-con­trolled tri­als test­ing them, in­clud­ing one by the WHO, ground to a halt.

Ear­li­er this week, how­ev­er, con­cerns about the ret­ro­spec­tive study and oth­er tri­als by the same lead au­thor and Har­vard pro­fes­sor Man­deep Mehra us­ing Sur­gi­sphere da­ta sur­faced. Af­ter an open let­ter signed by 150 doc­tors called in­to ques­tion the pa­per’s con­clu­sions and asked for pub­lic ac­cess to peer re­view com­men­tary that pre­ced­ed pub­li­ca­tion, on Tues­day Lancet ed­i­tors ac­knowl­edged that “im­por­tant sci­en­tif­ic ques­tions have been raised about da­ta re­port­ed” and that an in­de­pen­dent au­dit had been com­mis­sioned. On Wednes­day, the WHO restart­ed its tri­al. Yes­ter­day, the Lancet pa­per was re­tract­ed.

Sur­gi­sphere, the Chica­go-based com­pa­ny found­ed by the fourth au­thor of the Lancet pa­per Sapan De­sai, re­fused to trans­fer the full dataset, client con­tracts, and the full ISO au­dit re­port to their servers for analy­sis, cit­ing con­fi­den­tial­i­ty rea­sons. “As such, our re­view­ers were not able to con­duct an in­de­pen­dent and pri­vate peer re­view and there­fore no­ti­fied us of their with­draw­al from the peer-re­view process…based on this de­vel­op­ment, we can no longer vouch for the ve­rac­i­ty of the pri­ma­ry da­ta sources,” the first three au­thors of the Lancet study wrote in their re­trac­tion state­ment.

Mean­while, an­oth­er study led by Mehra us­ing Sur­gi­sphere da­ta in the New Eng­land Jour­nal of Med­i­cine (NE­JM) was al­so re­tract­ed on Thurs­day.

Mehra con­nect­ed with the vas­cu­lar sur­geon and sci­ence fic­tion writer De­sai through a co-au­thor, and per­son­al­ly re­viewed the Sur­gi­sphere analy­ses for both the Lancet and NE­JM pa­pers, he told the news di­vi­sion of the jour­nal Sci­ence.

But in the rush to pub­lish dur­ing the Covid-19 cri­sis, he con­ced­ed he “did not do enough to en­sure that the da­ta source was ap­pro­pri­ate for this use. For that, and for all the dis­rup­tions—both di­rect­ly and in­di­rect­ly—I am tru­ly sor­ry.” — Na­tal­ie Grover

Re­port­ed­ly snubbed by Op­er­a­tion Warp Speed, No­vavax gets up to $60M in DoD fund­ing 

If re­ports by the New York Times and Bloomberg are on the mon­ey, then No­vavax may not have made it to the whit­tled down short­list for fi­nan­cial and lo­gis­ti­cal sup­port from Op­er­a­tion Warp Speed — the White House-led am­bi­tious pub­lic-pri­vate ini­tia­tive to se­cure vac­cine ac­cess for Amer­i­cans be­fore the end of this year.

As a con­so­la­tion prize, how­ev­er, the Covid-19 vac­cine de­vel­op­er has been award­ed a con­tract of up to $60 mil­lion by the US De­part­ment of De­fense (DoD) to pro­duce of sev­er­al com­po­nents of the vac­cine in the coun­try. The deal in­cludes a 2020 de­liv­ery of 10 mil­lion dos­es of the vac­cine — called NVX‑CoV2373 — for DoD that could be used in Phase 2/3 clin­i­cal tri­als or un­der an emer­gency use au­tho­riza­tion (EUA) if grant­ed by the FDA, the com­pa­ny said.

No­vavax, which has a pipeline of ex­per­i­men­tal vac­cines for RSV, in­fluen­za and Ebo­la, has not yet man­aged to score any FDA vac­cine ap­provals akin to some oth­er Covid-19 vac­cine hope­fuls such as Mod­er­na and In­ovio. To make its can­di­date, No­vavax gen­er­at­ed an anti­gen de­rived from the spike pro­tein of SARS CoV 2, the virus that caus­es Covid-19, and added an ad­ju­vant to en­hance the im­mune re­sponse to the vac­cine.

An ear­ly-stage study was kicked off last month, and pre­lim­i­nary da­ta should be avail­able by Ju­ly. CEPI is putting in up to $388 mil­lion to fund the de­vel­op­ment.

Re­port­ed­ly, No­vavax was in­clud­ed in the ini­tial 18-name short­list for Op­er­a­tion Warp Speed.

Five groups — Mod­er­na, J&J, the joint As­traZeneca-Ox­ford, the Pfiz­er, BioN­Tech part­ner­ship and Mer­ck — who have made it to whit­tled down short­list as re­port­ed by the NYT and Bloomberg. But vac­cines made by No­vavax, Sanofi, In­ovio, Med­ica­go, the U.S. Army, British Amer­i­can To­bac­co, Coda­genix, In­sti­tut Pas­teur, Vaxart, Nan­tK­west, Geo­vax, Gr­ef­fex, and the Uni­ver­si­ty of Queens­land, were on the ini­tial 18-name short­list, ac­cord­ing to a Sci­ence re­port.

In mid-May how­ev­er, the HHS put out a state­ment say­ing it had a list of 14 ef­forts — from the more than 100 can­di­dates in de­vel­op­ment at com­pa­nies and uni­ver­si­ties — as a start­ing point. The of­fi­cial word from the HHS on what groups the short­er short­list con­tains is ex­pect­ed short­ly.

“It’s typ­i­cal Op­er­a­tion Warp Speed, where every­thing is sort of cryp­tic and it’s un­clear what they’re ac­tu­al­ly say­ing,” said Pe­ter Hotez, a vac­cine re­searcher at the Bay­lor Col­lege of Med­i­cine who is part of a team de­vel­op­ing a COVID-19 vac­cine in an in­ter­view with Sci­ence and serves on the vac­cine com­mit­tee of a pub­lic-pri­vate part­ner­ship or­ga­nized by the NIH that is sup­posed to as­sist Op­er­a­tion Warp Speed run clin­i­cal tri­als of cho­sen vac­cines.

But he and sev­er­al oth­er mem­bers of this com­mit­tee told Sci­ence that Op­er­a­tion Warp Speed did not ask for their in­put in the se­lec­tion. “We’re sort of like two par­al­lel uni­vers­es,” Hotez said. — Na­tal­ie Grover

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

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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