Covid-19 roundup: CanSi­no sub­mits vac­cine to Chi­nese reg­u­la­tors; As­traZeneca says an­ti­bod­ies show ear­ly ef­fi­ca­cy against new vari­ants — re­port

CanSi­no says their sin­gle-dose Covid-19 vac­cine is 65.28% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 cas­es, and they’ve of­fi­cial­ly filed for au­tho­riza­tion with Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

The vac­cine was 90.07% ef­fec­tive at pre­vent­ing se­vere dis­ease 28 days af­ter the sin­gle dose, ac­cord­ing to a state­ment re­port­ed by lo­cal me­dia. Ef­fi­ca­cy rates were slight­ly high­er 14 days af­ter the sin­gle dose, at 68.83% for symp­to­matic dis­ease and  95.47% for se­vere dis­ease.

The re­sults come from a mul­ti­cen­ter Phase III tri­al that took place in Pak­istan, Mex­i­co, Rus­sia, Chile and Ar­genti­na. To date, 40,000 vol­un­teers have been vac­ci­nat­ed, CanSi­no said.

Chi­na’s gov­ern­ment be­gan al­low­ing its mil­i­tary to use the ade­n­ovi­ral vec­tor-based vac­cine back in June, mak­ing it the first vac­cine ap­proved for lim­it­ed hu­man use. It was al­so Chi­na’s first vac­cine to en­ter hu­man test­ing.

Fac­ing con­cerns that the can­di­date had lim­it­ed ef­fi­ca­cy, CanSi­no en­tered a Phase I tri­al in Chi­na study­ing the ef­fi­ca­cy of a two-dose reg­i­men in Sep­tem­ber. That tri­al, which is ac­tive but no longer re­cruit­ing, en­rolled 149 par­tic­i­pants ac­cord­ing to reg­is­tra­tion records.

As­traZeneca says its an­ti­bod­ies show ear­ly ef­fi­ca­cy against new vari­ants — re­port

Ear­ly tests sug­gest that As­traZeneca’s mon­o­clon­al an­ti­body cock­tail ap­pears to be ef­fec­tive against emerg­ing vari­ants, the phar­ma’s head of mi­cro­bial sci­ences, Mark Ess­er, told Bloomberg. 

Ess­er said the an­ti­bod­ies showed promise against two strains first de­tect­ed in the UK and South Africa, Bloomberg’s Suzi Ring re­port­ed. In to­tal, As­traZeneca is run­ning five late-stage tri­als eval­u­at­ing the an­ti­bod­ies for pre­ven­tion and treat­ment — though Ess­er says the com­pa­ny is strug­gling with en­roll­ment as peo­ple drop out to get vac­ci­nat­ed.

AZD7442 en­tered an in­ter­na­tion­al Phase III tri­al back in No­vem­ber, with a tar­get of 5,000 par­tic­i­pants. So far, As­traZeneca has re­cruit­ed 3,000 vol­un­teers, Bloomberg re­port­ed.

Pro­phy­lac­tic treat­ments like the one As­traZeneca is de­vel­op­ing could prove use­ful for those with weak­er im­mune sys­tems, or those who don’t re­spond well to a vac­cine. AZD7442 is a com­bi­na­tion of two mon­o­clon­al an­ti­bod­ies that is de­signed to be in­ject­ed in­to the mus­cle.

Mene Pan­ga­los

“These have been en­gi­neered specif­i­cal­ly to have what we call a long half-life, (so) we think they will con­fer pro­tec­tion for (at least) six, but more like­ly clos­er to 12 months,” Mene Pan­ga­los, As­traZeneca’s ex­ec­u­tive vice pres­i­dent of bio­phar­ma­ceu­ti­cals R&D, said in No­vem­ber, per Reuters.

Eli Lil­ly clinched the first emer­gency use au­tho­riza­tion for a Covid-19 an­ti­body back in No­vem­ber, and racked up an­oth­er EUA ear­li­er this month for the use of its two-drug an­ti­body cock­tail in re­cent­ly di­ag­nosed pa­tients with mild to mod­er­ate dis­ease.

The news comes about a week af­ter the WHO ap­proved As­traZeneca and Ox­ford’s Covid-19 vac­cine. The As­traZeneca shot makes up the vast ma­jor­i­ty of CO­V­AX vac­cines, with more than 330 mil­lion dos­es sched­uled for de­liv­ery start­ing in late Feb­ru­ary.

NIH launch­es new ini­tia­tive study­ing Covid long-haulers

As a grow­ing num­ber of Covid-19 pa­tients re­port symp­toms that just won’t go away, the NIH has launched a new ini­tia­tive to un­der­stand the long-term ef­fects of the virus.

Large num­bers of pa­tients con­tin­ue to ex­pe­ri­ence a “con­stel­la­tion” of symp­toms af­ter re­cov­er­ing from the ini­tial stages of Covid-19, from “brain fog” to short­ness of breath, ac­cord­ing to the NIH. The symp­toms, dubbed “Long Covid,” can per­sist for months. And in some cas­es, new symp­toms arise over time.

Fran­cis Collins

“We do not know yet the mag­ni­tude of the prob­lem, but giv­en the num­ber of in­di­vid­u­als of all ages who have been or will be in­fect­ed with SARS-CoV-2, the coro­n­avirus that caus­es COVID-19, the pub­lic health im­pact could be pro­found,” NIH di­rec­tor Fran­cis Collins said in a state­ment.

With the help of $1.15 bil­lion from Con­gress over the next four years, the NIH is launch­ing the Post-Acute Se­que­lae of SARS-CoV-2 in­fec­tion (PASC) Ini­tia­tive in the hopes of ad­dress­ing key ques­tions, in­clud­ing what caus­es the pro­longed symp­toms and why some peo­ple are more vul­ner­a­ble than oth­ers.

The ini­tia­tive’s cen­tral pro­gram, the SARS-CoV-2 Re­cov­ery Co­hort, will fo­cus main­ly on char­ac­ter­iz­ing the long-term ef­fects and the tra­jec­to­ry of symp­toms over time. An­oth­er com­ple­men­tary study will source da­ta from health records and data­bas­es to un­der­stand how many peo­ple are af­fect­ed and what con­tributes to re­cov­ery. A sec­ond one will eval­u­ate in­jury to the brain and oth­er or­gans.

“Through this ini­tia­tive, we aim to learn more about how SARS-CoV-2 may lead to such wide­spread and last­ing symp­toms, and to de­vel­op ways to treat or pre­vent these con­di­tions,” Collins said. “We be­lieve that the in­sight we gain from this re­search will al­so en­hance our knowl­edge of the ba­sic bi­ol­o­gy of how hu­mans re­cov­er from in­fec­tion, and im­prove our un­der­stand­ing of oth­er chron­ic post-vi­ral syn­dromes and au­toim­mune dis­eases, as well as oth­er dis­eases with sim­i­lar symp­toms.”

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

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

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Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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FDA ad­comm nar­row­ly votes in fa­vor of Mer­ck­'s an­tivi­ral for out­pa­tient Covid-19

With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase 3 trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

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After some ups and downs surrounding the manufacturing of J&J’s Covid-19 vaccine as the South African company’s site, Aspen Pharmacare has announced an agreement with the pharma to make and sell an Aspen-branded Covid-19 vaccine through the continent.

The agreement will expand the already-existing tech transfer and agreement to give Aspen the right to make vaccines from drug substance supplied by J&J, and sell the finished form under the name Aspenovax to public sector markets in Africa.

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Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.