Stéphane Bancel (AP Images, Boston Herald)

Covid-19 roundup: FDA short­ens in­ter­val for Mod­er­na boost­er dose to 5 months; Mod­er­na CEO says an­oth­er boost­er could be nec­es­sary this fall — re­port

The FDA has short­ened the rec­om­mend­ed in­ter­val be­tween the pri­ma­ry se­ries of Mod­er­na’s Covid-19 vac­cine and a boost­er shot to at least five months for adults.

The news comes days af­ter the agency short­ened the time in­ter­val be­tween Pfiz­er and BioN­Tech’s pri­ma­ry se­ries and boost­er to five months for chil­dren and adults 12 years and old­er. The FDA has al­so cleared a third dose of the Pfiz­er/BioN­Tech shot for cer­tain kids ages five through 11 who are im­muno­com­pro­mised.

“The coun­try is in the mid­dle of a wave of the high­ly con­ta­gious omi­cron vari­ant, which spreads more rapid­ly than the orig­i­nal SARS-CoV-2 virus and oth­er vari­ants that have emerged,” Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, said in a state­ment.

Mod­er­na CEO says an­oth­er boost­er could be nec­es­sary this fall — re­port

While an Omi­cron-spe­cif­ic boost­er of Mod­er­na’s Covid-19 vac­cine prob­a­bly won’t be ready in the next cou­ple of months, ac­cord­ing to a Reuters re­port, CEO Stéphane Ban­cel says an­oth­er shot will like­ly be nec­es­sary for the fall.

“I still be­lieve we’re go­ing to need boost­ers in the fall of ’22 and for­ward,” Ban­cel said at a Gold­man Sachs-or­ga­nized event, per Reuters.

The news comes days af­ter Is­rael Prime Min­is­ter Naf­tali Ben­nett an­nounced that a study con­duct­ed in the coun­try sug­gests a fourth Covid-19 vac­cine dose spurs a five-fold in­crease in an­ti­bod­ies just a week af­ter be­ing ad­min­is­tered.

Ban­cel said in a re­cent let­ter to in­vestors that Mod­er­na con­tin­ues to eval­u­ate vari­ant-spe­cif­ic and mul­ti­va­lent vac­cines (com­bi­na­tions of vari­ant spe­cif­ic vac­cines) to stay ahead of fu­ture vari­ants, in­clud­ing Omi­cron.

“In ad­di­tion, we are eval­u­at­ing mR­NA-1283 as a next gen­er­a­tion, re­frig­er­a­tor sta­ble vac­cine,” he wrote.

Just be­fore the new year, Ban­cel re­vealed pre­lim­i­nary da­ta sug­gest­ing a boost­er dose of its orig­i­nal vac­cine, mR­NA-1273, was enough to kick up Omi­cron neu­tral­iz­ing an­ti­body lev­els dra­mat­i­cal­ly. The cur­rent­ly au­tho­rized 50 µg boost­er in­creased Omi­cron-spe­cif­ic an­ti­bod­ies around 37-fold com­pared to pre-boost lev­els, re­searchers re­port­ed, while a 100 µg dose in­creased neu­tral­iz­ing an­ti­body lev­els ap­prox­i­mate­ly 83-fold.

J&J touts re­al-world da­ta sup­port­ing a sin­gle dose of its vac­cine

The CDC rec­om­mend­ed weeks ago that Amer­i­cans re­ceive one of the mR­NA vac­cines over J&J’s sin­gle-dose vac­cine due to re­newed con­cerns about blood clots. But the phar­ma gi­ant isn’t back­ing down.

On Thurs­day, J&J un­veiled new re­al-world da­ta that sug­gest a sin­gle shot of its Covid-19 vac­cine of­fered pro­tec­tion against break­through in­fec­tions, hos­pi­tal­iza­tions, and ICU ad­mis­sions for up to six months.

It’s im­por­tant to note that da­ta from the J&J-spon­sored tri­al are pre­lim­i­nary, and have yet to be peer-re­viewed. And they were col­lect­ed be­fore the Omi­cron vari­ant was dis­cov­ered.

One month post-vac­ci­na­tion, J&J re­port­ed ef­fi­ca­cy rates of 81% for pre­vent­ing hos­pi­tal­iza­tion and 74% for pre­vent­ing break­through in­fec­tions. Over the course of six months, the phar­ma said there was no ev­i­dence of wan­ing pro­tec­tion against hos­pi­tal­iza­tions or Covid-re­lat­ed ICU ad­mis­sions. How­ev­er, there was some “mod­est wan­ing” of pro­tec­tion against break­through in­fec­tions start­ing in month 4.

J&J not­ed that wan­ing pro­tec­tion against break­through cas­es be­gan in month 2 for both the Mod­er­na and Pfiz­er/BioN­Tech shots.

The study was con­duct­ed us­ing na­tion­al claims, lab and hos­pi­tal da­ta for 17 mil­lion ful­ly-vac­ci­nat­ed in­di­vid­u­als be­tween Jan. 1 and Sept. 7, 2021.

A few weeks ago, the CDC rec­om­mend­ed against tak­ing J&J’s shot if ei­ther the Pfiz­er/BioN­Tech or Mod­er­na shot is avail­able, over con­cerns about rare but some­times fa­tal blood clots. J&J’s vac­cine will still be avail­able to those who are un­able or un­will­ing to get an mR­NA vac­cine.

Math­ai Mam­men

“We con­tin­ue to un­der­take ex­ten­sive ef­forts to study the dura­bil­i­ty of pro­tec­tion of­fered by the John­son & John­son vac­cine amidst the ever-chang­ing COVID-19 pan­dem­ic,” Math­ai Mam­men, Janssen’s ex­ec­u­tive VP of phar­ma­ceu­ti­cals, said in a state­ment.

The FDA and CDC put a hold on J&J’s vac­cine back in April to as­sess the risk of such blood clots but end­ed up lift­ing the pause less than two weeks lat­er af­ter de­cid­ing that the shot’s known and po­ten­tial ben­e­fits still out­weigh the risks.

But at an ACIP meet­ing, it was re­vealed that there are more cas­es of throm­bo­sis with throm­bo­cy­tope­nia syn­drome (TTS) in those who re­ceived the J&J vac­cine than pre­vi­ous­ly thought.

J&J put out a state­ment that it re­mains con­fi­dent in the vac­cine’s ben­e­fit-risk pro­file.

Alexander Lefterov/Endpoints News

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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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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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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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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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.