Mene Pangalos (AstraZeneca via YouTube)

Pas­sive vac­ci­na­tion? As­traZeneca spot­lights six-month pro­tec­tion with Covid-19 an­ti­body among vul­ner­a­ble group

New fol­low-up da­ta sug­gest that As­traZeneca’s long-act­ing an­ti­body can pro­tect high-risk pop­u­la­tions from con­tract­ing Covid-19 for as long as six months, beef­ing up the case for it as a form of “pas­sive im­mu­niza­tion” or “pas­sive vac­ci­na­tion.”

At a six-month cut­off for the Phase III PROVENT tri­al, in­ves­ti­ga­tors tracked an 83% re­duc­tion in risk of symp­to­matic Covid-19 af­ter one dose of the an­ti­body among 4,991 vol­un­teers. The com­pa­ny did not spell out case counts on ei­ther arm, not­ing on­ly that there were no se­vere dis­ease or Covid-re­lat­ed deaths in the AZD7442 arm and two ad­di­tion­al cas­es of se­vere Covid-19 in the place­bo arm (for a to­tal of five se­vere cas­es and two re­lat­ed deaths).

Com­ing al­most two months af­ter the ini­tial read­out, the up­date was re­leased along­side a new analy­sis of the TACK­LE tri­al, which test­ed AZD7442 as a treat­ment and showed that, when giv­en with­in three days of symp­tom on­set, it can cut the risk of se­vere dis­ease or death by 88% — a sig­nif­i­cant leap from the pre­vi­ous­ly re­port­ed 50% num­ber when treat­ment was giv­en with­in sev­en days.

To­geth­er, As­traZeneca said, they paint a fuller pic­ture of AZD7442, which it had first li­censed from Van­der­bilt, as an im­por­tant ad­di­tion to the ar­se­nal.

“AZD7442 is the on­ly long-act­ing an­ti­body with Phase III da­ta to demon­strate ben­e­fit in both pre-ex­po­sure pro­phy­lax­is and treat­ment of COVID-19 with one dose,” said Mene Pan­ga­los, EVP of bio­phar­ma R&D in a state­ment.

In a re­cent in­ter­view with End­points News, Pan­ga­los em­pha­sized how the drug’s long-act­ing prop­er­ty sets it apart from oth­er an­ti­bod­ies. Eli Lil­ly, Re­gen­eron and Vir/Glax­o­SmithK­line have all nabbed emer­gency use au­tho­riza­tions for their ther­a­pies, with an uptick in use amid new surges due to the Delta vari­ant and break­through cas­es.

“Oth­ers are talk­ing about pro­phy­lax­is, but they’re talk­ing about month­ly ad­min­is­tra­tion,” he said. “We’re talk­ing about, po­ten­tial­ly, at a max­i­mum twice a year, I’m hop­ing it’ll be once a year. And so al­most in a way be, you know, pas­sive im­mu­niza­tion or pas­sive vac­ci­na­tion.”

The FDA is cur­rent­ly re­view­ing an EUA fil­ing in the pro­phy­lac­tic set­ting.

It’s es­pe­cial­ly rel­e­vant when you con­sid­er that PROVENT sought to en­roll par­tic­i­pants who are im­muno­com­pro­mised — peo­ple with mul­ti­ple scle­ro­sis, say, or can­cer. These peo­ple, es­ti­mat­ed to make up about 2 to 3% of the pop­u­la­tion, are thought to be less pro­tect­ed by vac­ci­na­tion.

“Im­por­tant­ly, six months of pro­tec­tion was main­tained de­spite the surge of the Delta vari­ant among these high-risk par­tic­i­pants who may not re­spond ad­e­quate­ly to vac­ci­na­tion,” said Hugh Mont­gomery, prin­ci­pal in­ves­ti­ga­tor and pro­fes­sor of in­ten­sive care med­i­cine at Uni­ver­si­ty Col­lege Lon­don.

On the treat­ment side, TACK­LE sim­i­lar­ly tar­get­ed pa­tients at high risk of pro­gres­sion to se­vere Covid-19 for en­roll­ment — with 90% of par­tic­i­pants in that cat­e­go­ry. Again, there was no break­down on the num­ber of cas­es in each group.

The new, ex­plorato­ry analy­sis sug­gest­ed that when giv­en soon­er af­ter symp­tom on­set, a sin­gle dose of AZD7442 could bet­ter pre­vent those se­vere out­comes much bet­ter than place­bo among non-hos­pi­tal­ized pa­tients. “You could treat with an oral an­tivi­ral, that’s great,” Pan­ga­los said. “Now, you could treat with an an­ti­body, or you could treat with ours down the road as well, and you won’t just be treat­ed for the two weeks that you’ve got the symp­toms. You’ll be treat­ed the next 12 months in terms of pre­ven­tion.”

In a Q&A call this morn­ing, CEO Pas­cal So­ri­ot con­firmed that plans for a pe­di­atric tri­al are un­der­way. And in terms of pric­ing, what that will look like hasn’t been de­ter­mined yet — EVP Iskra Re­ic on­ly said they are pur­su­ing a “com­mer­cial pric­ing strat­e­gy.”

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

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Steve Worland, eFFECTOR CEO

Sur­prise piv­ot rocks eF­FEC­TOR's I/O plans — al­though ex­ecs promise big­ger slice of the NSCLC mar­ket in the long run

When eFFECTOR Therapeutics went public last summer on the coattails of a reverse merger with Locust Walk’s SPAC, the potential of its lead drug, tomivosertib, as a combo agent with Merck’s flagship PD-1 Keytruda was hailed as the main draw.

But the biotech is now axing those plans and essentially starting over.

In a surprise move, San Diego-based eFFECTOR said it’s halting the development of tomivosertib in non-small cell lung cancer patients who have already progressed on Keytruda monotherapy after running into enrollment challenges in a Phase IIb trial.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.