Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA re­leased brief­ing doc­u­ments this week from the agency and Pfiz­er each out­lin­ing their ar­gu­ments for to­day’s Covid-19 boost­er shot ad­comm, but one thing con­spic­u­ous­ly miss­ing was the ques­tion on which pan­el mem­bers would be vot­ing. But late Thurs­day night, reg­u­la­tors pub­lished that ques­tion.

Ad­comm mem­bers will be asked whether or not the safe­ty and ef­fi­ca­cy da­ta from Pfiz­er/BioN­Tech’s orig­i­nal Phase III study “sup­port ap­proval” of a boost­er shot at least six months af­ter the sec­ond dose in in­di­vid­u­als old­er than 16. The ques­tion no­tably ex­cludes the re­al-world da­ta from Is­rael and oth­er analy­ses that Pfiz­er and the Biden ad­min­is­tra­tion had said would be a cen­ter­piece of their ar­gu­ments for boost­ers.

It’s not im­me­di­ate­ly clear whether this ques­tion would be the on­ly one asked at the ad­comm, but the FDA had yet to up­date its web­site as of ear­ly Fri­day morn­ing.

Here’s the ex­act word­ing:

Do the safe­ty and ef­fec­tive­ness da­ta from clin­i­cal tri­al C4591001 sup­port ap­proval of a COMIR­NATY boost­er dose ad­min­is­tered at least 6 months af­ter com­ple­tion of the pri­ma­ry se­ries for use in in­di­vid­u­als 16 years of age and old­er? Please vote Yes or No.

Pfiz­er spent much of its 53-page brief­ing doc­u­ment on the var­i­ous ob­ser­va­tion­al stud­ies that have popped up dur­ing the Delta surge, show­ing the vac­cine’s pro­tec­tion against mild dis­ease wan­ing over time but re­main­ing very strong against se­vere Covid-19 and hos­pi­tal­iza­tion. The FDA’s brief­ing doc­u­ments, how­ev­er, spent on­ly two para­graphs ad­dress­ing those stud­ies, say­ing there is a lot that present “con­flict­ing con­clu­sions.”

The word­ing of the ques­tion dif­fers con­sid­er­ably from those asked in the orig­i­nal vac­cine ad­comms last year, be­fore any vac­cine had been au­tho­rized or ap­proved. Fri­day’s ques­tion fo­cus­es specif­i­cal­ly on sup­port­ing ap­proval, where­as the old­er ques­tions asked whether or not the ben­e­fits of the vac­cine out­weighed the risks.

It’s a phras­ing some out­side ob­servers strug­gled to in­ter­pret. Walid Gel­lad, di­rec­tor of the Uni­ver­si­ty of Pitts­burgh Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing, not­ed in a Twit­ter thread Thurs­day night the con­trast be­tween the ques­tion and the “nar­row” fo­cus on the Phase III study.

— Max Gel­man

FDA ex­pands EUA for Eli Lil­ly’s an­ti­body cock­tail to cov­er pre­ven­tion

Eli Lil­ly and Ab­Cellera are square­ly back in ac­tion.

Just days af­ter the US re­sumed dis­tri­b­u­tion of their an­ti­body cock­tail na­tion­wide to fight against a surge in cas­es — dom­i­nat­ed by the Delta vari­ant — the com­pa­nies said the com­bo of bam­lanivimab and ete­se­vimab has been cleared for emer­gency use to pre­vent Covid-19 in peo­ple who have been ex­posed to some­one in­fect­ed with SARS-CoV-2 or at high risk of ex­po­sure, such as in the prison or nurs­ing home set­ting.

It marks the sec­ond EUA the FDA has is­sued for post-ex­po­sure pro­phy­lax­is, af­ter grant­i­ng the same ex­pan­sion for Re­gen­eron’s an­ti­bod­ies.

On top of pro­tect­ing peo­ple who have not been ful­ly vac­ci­nat­ed, Lil­ly notes that in­di­vid­u­als who can’t mount an ad­e­quate im­mune re­sponse to com­plete vac­ci­na­tion may ben­e­fit from the drugs. It’s sanc­tioned for high-risk in­di­vid­u­als 12 or old­er.

The com­bi­na­tion of a low vac­ci­na­tion rate and a rise in break­through Covid-19 cas­es has trans­lat­ed to sky­rock­et­ing de­mand for mon­o­clon­al an­ti­bod­ies. Just days ago, Re­gen­eron re­vealed the gov­ern­ment has placed a new, $2.9 bil­lion or­der for 1.4 mil­lion ad­di­tion­al dos­es of its an­ti­bod­ies.

Lil­ly had li­censed bam­lanivimab from Ab­Cellera and ete­se­vimab from Shang­hai’s Jun­shi to put to­geth­er the com­bo.

“The ex­pand­ed use au­tho­riza­tion for bam­lanivimab to­geth­er with ete­se­vimab pro­vides a way to pro­tect the sig­nif­i­cant num­ber of peo­ple who, be­cause of their sit­u­a­tion­al ex­po­sure risk or med­ical con­di­tion, re­main vul­ner­a­ble to COVID-19,” Ab­Cellera CEO Carl Hansen said in a state­ment. “More than 535,000 pa­tients have been treat­ed with bam­lanivimab alone or to­geth­er with ete­se­vimab, po­ten­tial­ly keep­ing more than 25,000 pa­tients out of the hos­pi­tal and sav­ing more than 10,000 lives.”

— Am­ber Tong

Re­searchers peg As­traZeneca/Ox­ford, Pfiz­er/BioN­Tech vac­cine im­mu­ni­ty about 1 year

A group of Ox­ford sci­en­tists says the Covid-19 vac­cine that their col­leagues have de­vel­oped with As­traZeneca ap­pears to kick up an­ti­bod­ies that last equal­ly as long as the ones elicit­ed by Pfiz­er and BioN­Tech’s ri­val shot.

An­a­lyz­ing an­ti-spike IGG an­ti­body re­spons­es among 186,527 vac­ci­nat­ed peo­ple in the UK to fig­ure out the du­ra­tion of pro­tec­tion of­fered by the two vac­cines, the re­searchers con­clud­ed:

Pro­tec­tion based on cur­rent pos­i­tiv­i­ty thresh­olds can last for at least 0.5-1 year for ChA­dOx1 and over a year for BNT162b2; how­ev­er, giv­en the re­duced ef­fec­tive­ness against vari­ants of con­cern, the du­ra­tion of pro­tec­tion may be sig­nif­i­cant­ly re­duced. These re­sults may in­form vac­ci­na­tion strate­gies; a third boost­ing dose may be need­ed, and could be pri­ori­tised to the more vul­ner­a­ble pop­u­la­tion groups.

They al­so found that no mat­ter when it’s giv­en af­ter the first dose, a sec­ond dose of ChA­dOx1 and BNT162b2 in­duced “sig­nif­i­cant boost­ing” of an­ti-spike an­ti­bod­ies tar­get­ing SARS-CoV-2.

There was, how­ev­er, a key dif­fer­ence: An­ti­body lev­els de­clined faster for younger in­di­vid­u­als af­ter a sec­ond dose of the Ox­ford/As­traZeneca vac­cine, while old­er peo­ple get­ting BNT162b2 saw their lev­els de­cline faster — al­though it was off­set by high­er peak lev­els.

“In the most vul­ner­a­ble groups, the net ef­fect was a sim­i­lar du­ra­tion of time above dif­fer­ent thresh­olds from the two vac­cines, but with longer du­ra­tions with BNT162b2 in younger groups,” they added.

No­tably, they al­so of­fered a coun­ter­point to re­cent stud­ies that sug­gest­ed longer dos­ing in­ter­vals may gen­er­ate more im­mu­ni­ty, sug­gest­ing that the dif­fer­ences in an­ti­body lev­els may be re­lat­ed to how and when those stud­ies mea­sured an­ti­body lev­els.

— Am­ber Tong

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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