Covid-19 roundup: Re­gen­eron asks FDA: Which gov­ern­ment agen­cies are track­ing vari­ants of con­cern?; Pfiz­er, As­traZeneca vac­cines most­ly hold strong against Delta vari­ant

As the race to keep Covid-19 vari­ants at bay con­tin­ues, Re­gen­eron is call­ing on the FDA to pro­vide ad­di­tion­al clar­i­ty on which gov­ern­ment agen­cies are ac­tu­al­ly track­ing and pub­lish­ing lists on vari­ants of con­cern like the Delta vari­ant.

The New York-based biotech, which has made a name for it­self dur­ing the pan­dem­ic for not on­ly treat­ing for­mer Pres­i­dent Trump with its an­ti­body cock­tail but al­so de­vel­op­ing a cock­tail that can with­stand the chang­ing na­ture of the coro­n­avirus in the US. Mean­while, its com­peti­tors from Eli Lil­ly were pulled from the mar­ket late last month as vari­ants were able to pen­e­trate the firm’s an­ti­body drugs.

Lil­ly clar­i­fied that its com­bo of bam­lanivimab and ete­se­vimab ad­min­is­tered to­geth­er does not re­tain neu­tral­iza­tion ef­fects against the Gam­ma or Be­ta vari­ants, has slight­ly re­duced ac­tiv­i­ty against the Ep­silon, Io­ta and Kap­pa vari­ants, but does re­tain neu­tral­iza­tion ac­tiv­i­ty against the Delta and Al­pha vari­ants.

“Spon­sors de­vel­op­ing mon­o­clon­al an­ti­bod­ies tar­get­ing emerg­ing SARS-CoV-2 vari­ants would ben­e­fit from know­ing which Agen­cies are track­ing and pub­lish­ing lists with the vari­ants of con­cerns that should be tar­get­ed, sim­i­lar­ly to what is done with in­fluen­za virus strains,” Re­gen­eron said in a com­ment post­ed re­cent­ly by the FDA.

A Re­gen­eron spokesper­son not­ed to End­points News that the com­pa­ny of­fers a pub­licly-avail­able track­ing dash­board on vari­ants, in­clud­ing through this dash­board we’ve made pub­licly avail­able and that is re­freshed dai­ly with new genomes/meta­da­ta from GI­SAID, which is a glob­al ini­tia­tive and pri­ma­ry source that pro­vides open-ac­cess to ge­nom­ic da­ta of in­fluen­za virus­es and the coro­n­avirus.

The biotech al­so sug­gest­ed that FDA could strength­en its rec­om­men­da­tions from its Feb­ru­ary guid­ance, and help en­sure that spon­sors are best po­si­tioned to de­vel­op mon­o­clon­al an­ti­bod­ies to the SARS-CoV-2 vari­ants pos­ing the great­est threats to pub­lic health.

Re­gen­eron al­so sug­gest­ed that the CDC and/or the WHO guid­ance doc­u­ments on vari­ants are ref­er­enced in FDA’s guid­ance. — Zachary Bren­nan

New study shows Pfiz­er/BioN­Tech, As­traZeneca vac­cines hold up against Delta vari­ant

A new study found “on­ly mod­est dif­fer­ences” in pro­tec­tion of­fered by the Pfiz­er/BioN­Tech and As­traZeneca Covid-19 vac­cines against the Delta vari­ant, which has be­come the dom­i­nant strain in the US.

On Tues­day, CDC di­rec­tor Rochelle Walen­sky said the Delta vari­ant, which was first iden­ti­fied in In­dia, now ac­counts for about 83% of all Covid-19 cas­es in the US, up from just over 50% a few days pri­or. This par­tic­u­lar strain is thought to have in­creased repli­ca­tion, which leads to high­er vi­ral loads and in­creased trans­mis­sion.

Ear­li­er this month, re­searchers at the Guang­dong Provin­cial Cen­ter for Dis­ease Con­trol and Pre­ven­tion re­port­ed that on av­er­age, peo­ple in­fect­ed with the new strain had 1,000 times more copies of the virus in their res­pi­ra­to­ry tracts than those in­fect­ed with the orig­i­nal strain.

Ac­cord­ing to a study fund­ed by Pub­lic Health Eng­land and pub­lished in the New Eng­land Jour­nal of Med­i­cine, two dos­es of Pfiz­er’s vac­cine were found to be 88% ef­fec­tive against the Delta vari­ant, com­pared to 93.7% ef­fec­tive against the Al­pha strain. And As­traZeneca’s shot was 67% ef­fec­tive against the Delta vari­ant, ver­sus 74.5% ef­fec­tive against the Al­pha.

The pro­tec­tion of­fered by just one shot of ei­ther vac­cine was “no­tably low­er,” the re­searchers said, with both vac­cines show­ing ef­fi­ca­cy rates around 30.7% for the Delta vari­ant and 48.7% for the Al­pha vari­ant.

“On­ly mod­est dif­fer­ences in vac­cine ef­fec­tive­ness were not­ed with the delta vari­ant as com­pared with the al­pha vari­ant af­ter the re­ceipt of two vac­cine dos­es,” the re­searchers wrote.

A dif­fer­ent study pub­lished on Mon­day (which has not been peer-re­viewed) showed that neu­tral­iz­ing titers in­duced by J&J’s vac­cine de­creased 5.4-fold against the “Delta plus” vari­ant, a mu­ta­tion that sci­en­tists say al­lows the virus to bet­ter at­tack the lungs. — Nicole De­Feud­is

Top Chi­nese of­fi­cial speaks out against WHO’s Covid-19 ori­gin study — re­port 

Amid brew­ing con­tro­ver­sy over the ori­gins of Covid-19, Chi­na’s Na­tion­al Health Com­mis­sion Vice Min­is­ter Zeng Yix­in said he was “rather tak­en aback” by the World Health Or­ga­ni­za­tion’s plans for the sec­ond phase of a study to rule out whether the virus leaked from a lab, ac­cord­ing to the As­so­ci­at­ed Press. 

Zeng re­port­ed­ly dis­missed the lab-leak the­o­ry as a ru­mor lack­ing in com­mon sense.

“It is im­pos­si­ble for us to ac­cept such an ori­gin-trac­ing plan,” he told re­porters, per the AP.

The WHO said back in Feb­ru­ary that the pos­si­bil­i­ty of the nov­el coro­n­avirus stem­ming from the re­sult of a lab ac­ci­dent was “ex­treme­ly un­like­ly,” adding that ev­i­dence con­tin­ues to point to the virus jump­ing from an­i­mals to hu­mans.

How­ev­er, the lab ac­ci­dent the­o­ry, which was at times pro­mot­ed by for­mer Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion, has gained trac­tion in the US, with the con­tro­ver­sy erupt­ing back in May when Pres­i­dent Joe Biden or­dered the US com­mu­ni­ty and gov­ern­ment labs to dou­ble down on their ef­forts to reach a con­sen­sus.

“Cer­tain­ly, the peo­ple who in­ves­ti­gat­ed it say it like­ly was the emer­gence from an an­i­mal reser­voir that then in­fect­ed in­di­vid­u­als, but it could have been some­thing else, and we need to find that out. So, you know, that’s the rea­son why I said I’m per­fect­ly in fa­vor of any in­ves­ti­ga­tion that looks in­to the ori­gin of the virus,” NI­AID di­rec­tor An­tho­ny Fau­ci said at a Sen­ate Ap­pro­pri­a­tions Com­mit­tee hear­ing in May.

Chi­nese of­fi­cials have re­peat­ed­ly de­nied that the Wuhan In­sti­tute of Vi­rol­o­gy in Chi­na had any­thing to do with the out­break, and Zeng said the Wuhan lab has no virus that can di­rect­ly in­fect hu­mans, ac­cord­ing to the AP. — Nicole De­Feud­is

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.

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.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Shankar Musunuri, Ocugen CEO

Ocu­gen hits an­oth­er snag in bring­ing its Bharat Biotech-part­nered Covid-19 vac­cine to the US

Back in July, Ocugen and Bharat Biotech unveiled some Phase III data suggesting their Covid-19 vaccine, Covaxin, was 77.8% effective at preventing overall disease in India. They’re now looking to launch an immuno-bridging study to see if those numbers hold up in the US — but on Friday, the FDA said not so fast.

Regulators have placed a clinical hold on the partners’ IND, Ocugen shared on Friday. Ocugen’s stock $OCGN sank 9% on the news Friday, but was up almost 7% in pre-market trading on Monday.

Covid-19 roundup: As Omi­cron spreads, African biotech re­port­ed­ly close to re­pro­duc­ing Mod­er­na's vac­cine, while WHO cre­ates pan­dem­ic pre­ven­tion body

The emergence of the Omicron variant over the holiday has reignited the focus on vaccine equity, and in its efforts to bring more shots to Africa, one South African biotech is reportedly close to reproducing Moderna’s mRNA shot.

Afrigen Biologics and Vaccines is speeding toward its pivotal trials, the Washington Post reported Sunday, though it’s doing so without Moderna’s recipe. The biotech reportedly has finished sequencing the Moderna vaccine and plans to soon compare its own recreation to Moderna’s jab.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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