Covid-19 roundup: In­ovio gets FDA green­light to en­ter hu­man tri­als; Trump push­es untest­ed malar­ia drugs again

In­ovio, one of the clutch of com­pa­nies work­ing on a Covid-19 vac­cine, has been cleared by the FDA to kick off in-hu­man stud­ies of its ex­per­i­men­tal vac­cine can­di­date. The Penn­syl­va­nia com­pa­ny se­cured fund­ing from the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions (CEPI) and the Bill and Melin­da Gates Foun­da­tion to sup­port its ef­fort.

The tri­al test­ing the DNA vac­cine, INO-4800, in up to 40 healthy vol­un­teers is set to be­gin this week, and the first dose is planned to be ad­min­is­tered to­day. Each par­tic­i­pant will re­ceive two dos­es of INO-4800 a month apart, and the ini­tial im­mune re­spons­es and safe­ty da­ta from the study are ex­pect­ed by late sum­mer, the com­pa­ny said. Shares of In­ovio — which in four decades of ex­is­tence has not suc­cess­ful­ly de­vel­oped a prod­uct — $INO jumped about 11% to $8.60 in pre­mar­ket trad­ing.

Sci­en­tists es­ti­mate the ear­li­est a vi­able vac­cine can be ap­proved, even with ex­pe­dit­ed R&D and reg­u­la­to­ry re­view, is be­tween 12 to 18 months. The on­ly oth­er vac­cines to be in hu­man stud­ies are from Mod­er­na Ther­a­peu­tics, which is col­lab­o­rat­ing with the NIH, as well as Chi­na’s CanSi­no Bi­o­log­ics. Mod­er­na got their vac­cine in­to Phase I with­in 42 days, but did so by con­tro­ver­sial­ly putting in­to hu­mans be­fore com­plet­ing the or­di­nary an­i­mal test­ing, a fact In­ovio CEO Joseph Kim not­ed oblique­ly in an in­ter­view.

“In less than 3 months, we were able to de­sign the vac­cine, along the way con­duct­ing all the tests,” Kim told End­points News. “We did not take those risky short­cuts. We just did things faster.”

Still, re­searchers broad­ly have greater ex­pec­ta­tions for the mR­NA vac­cine be­ing de­vel­oped by Mod­er­na and oth­ers, in part be­cause mR­NA vac­cines can just en­ter the cell, while DNA vac­cines have to reach the cell nu­cle­us. For that rea­son, af­ter re­ceiv­ing the DNA vac­cine it­self, the vol­un­teers in In­ovio’s study will re­ceive 3 shots of elec­trophore­sis that guide the DNA to the de­sired spot.

It’s “a lit­tle bit more dif­fi­cult from a mol­e­c­u­lar bi­ol­o­gy per­spec­tive com­pared to mR­NA,” CEPI pro­grams and tech­nol­o­gy R&D chief Nick Jack­son told End­points in Feb­ru­ary.

Kim said they are work­ing with the FDA on de­sign­ing Phase II and Phase III stud­ies. The Phase II could be­gin as ear­ly as this sum­mer, a sim­i­lar time­line to the one put forth by Mod­er­na.

Trump lauds malar­ia drugs again

In a White House brief­ing on Sun­day, Pres­i­dent Trump once again is­sued an im­pas­sioned en­dorse­ment of malar­ia drugs chloro­quine and hy­drox­y­chloro­quine as treat­ments for Covid-19, as the virus be­hind the dis­ease rav­ages the Unit­ed States.

“I want peo­ple to live, and I’m see­ing peo­ple dy­ing. I’ve seen peo­ple dy­ing with­out it! They should do it (use the drugs), what re­al­ly do we have to lose?” he said. “This med­i­cine’s been test­ed for many years, for malar­ia and for lu­pus and its been out there, so it’s out there and it doesn’t kill peo­ple. We have some very good re­sults and some very good tests — but we don’t have time to say gee, let’s take a cou­ple of years and test it out, and let’s go and test with the test tubes and the lab­o­ra­to­ries.”

Trump, who is not a physi­cian, has been tout­ing the pair of drugs as Covid-19 treat­ments for weeks now, de­spite cau­tion from his own sci­en­tif­ic ad­vi­sors, in­clud­ing in­fec­tious dis­ease ex­pert and NI­AID chief An­tho­ny Fau­ci who has in­sist­ed that there is no strong sci­en­tif­ic proof back­ing their ef­fi­ca­cy against Covid-19. When a re­porter tried to en­gage Fau­ci di­rect­ly to weigh in on the drugs on Sun­day, Trump in­ter­vened.

A few tiny tri­als out of France and Chi­na have so far yield­ed in­con­clu­sive ev­i­dence on the use of the drugs in pa­tients with Covid-19.

Er­ic Topol — car­di­ol­o­gist, au­thor and founder of the Scripps Re­search Trans­la­tion­al In­sti­tute — un­der­scored that da­ta on the use of the drugs in Covid-19 is in­com­ing, that they can cause se­ri­ous side ef­fects, and that the treat­ments are not ap­proved by the FDA as as­sert­ed by Trump.

In the mid­dle of March, Trump per­son­al­ly pressed fed­er­al health of­fi­cials to make the malar­ia drugs avail­able to treat the new coro­n­avirus, Reuters re­port­ed. Soon af­ter, the FDA cit­ed lim­it­ed in-vit­ro and anec­do­tal clin­i­cal da­ta to en­dorse the emer­gency use of the two ther­a­pies to treat malar­ia and lu­pus among oth­er dis­or­ders for Covid-19 when clin­i­cal tri­als are not avail­able, or par­tic­i­pa­tion is not fea­si­ble.

“The pres­i­dent is short-cir­cuit­ing the process with his gut feel­ings,” said Jef­frey Fli­er, a for­mer dean of Har­vard Med­ical School told Reuters.  “We are in an emer­gency and we need to re­ly on our gov­ern­ment to en­sure that all these po­ten­tial ther­a­pies are test­ed in the most ef­fec­tive and ob­jec­tive way.”

In a state­ment to the wire agency, the White House de­nied the pres­i­dent had launched a “pres­sure cam­paign,” and sug­gest­ed he was tak­ing “ap­pro­pri­ate ac­tion.”

Rudy Giu­liani, for­mer New York City may­or and un­paid pri­vate at­tor­ney to Trump dur­ing the im­peach­ment pro­ceed­ings, has tak­en it up­on him­self to be­come a per­son­al sci­ence ad­vis­er to Trump, the Wash­ing­ton Post re­port­ed.

Giu­liani, who has pub­licly laud­ed the drugs on his Twit­ter feed and a pod­cast that he records in a stu­dio in­stalled at his New York City apart­ment, said he had not dis­cussed the drugs with Fau­ci, but that Trump agrees with him. “I’m sure he thinks I am an ig­no­ra­mus,” he said of Fau­ci, to the Post.

“They’ve thrown cold wa­ter on it be­cause they are aca­d­e­mics,” he said of sci­en­tists like Fau­ci. “ ‘You can’t blind test it.’ I know you can’t blind test it. But we’ve got thou­sands of peo­ple dy­ing, sweet­heart. And by the time you blind test it, we’ll have 100,000 peo­ple who are dead. Why don’t we get in the re­al world of be­ing a doc­tor in­stead of be­ing an aca­d­e­m­ic?”

Mean­while, there is grow­ing strife be­tween Trump’s med­ical ad­vi­sors and the pres­i­dent, the New York Times re­port­ed. On Fri­day, when the gov­ern­ment ad­vised Amer­i­cans wear masks when out in pub­lic, Trump re­fused to fol­low suit. While health ad­vi­sors and some law­mak­ers are push­ing for a uni­fied re­sponse to the pan­dem­ic such as a uni­form stay-at-home or­der for the en­tire na­tion, Trump has re­sist­ed and in­stead shift­ed blame to the states for be­ing un­pre­pared to deal with the virus.

“I don’t un­der­stand why that’s not hap­pen­ing,” Fau­ci said Thurs­day night on CNN. “The ten­sion be­tween fed­er­al­ly man­dat­ed ver­sus states’ rights to do what they want is some­thing I don’t want to get in­to. But if you look at what is go­ing on in this coun­try, I don’t un­der­stand why we’re not do­ing that. We re­al­ly should be.”

Take­da en­lists part­ners to as­sist with its plas­ma ther­a­py ef­fort

Take­da, which is de­vel­op­ing a plas­ma-de­rived ther­a­py from the blood of coro­n­avirus pa­tients who have re­cov­ered from the res­pi­ra­to­ry dis­ease, has en­list­ed blood prod­ucts com­pa­ny CSL Behring in its mis­sion. Biotest, BPL, LFB, and Oc­taphar­ma have joined al­so joined the al­liance, which is open to oth­er com­pa­nies pitch­ing in.

“Lead­ers lead dur­ing un­cer­tain­ty,” said Bill Mez­zan­otte, CSL Behring’s head of R&D. “This ef­fort aims to ac­cel­er­ate a re­li­able, scaleable and sus­tain­able op­tion for care­givers to treat pa­tients suf­fer­ing from the im­pact of COVID-19. In ad­di­tion to pool­ing in­dus­try re­sources, we will al­so col­lab­o­rate with gov­ern­ment and aca­d­e­m­ic ef­forts as a sin­gle al­liance when­ev­er we can, in­clud­ing im­por­tant ac­tiv­i­ties like clin­i­cal tri­als. This will make it more ef­fi­cient in these hec­tic times for these stake­hold­ers as well.”

British PM Boris John­son, who has test­ed pos­i­tive for Covid-19, is ad­mit­ted to hos­pi­tal

The 55-year old John­son was ad­mit­ted to the hos­pi­tal for undis­closed tests as a “pre­cau­tion­ary step” on Sun­day, af­ter suf­fer­ing per­sis­tent coro­n­avirus symp­toms ten days af­ter test­ing pos­i­tive for the virus. The news emerged soon af­ter Queen Eliz­a­beth made a rare ad­dress — on­ly her fifth such speech in her 68-year reign — urg­ing the na­tion to fol­low gov­ern­ment rules to stay at home and praised those “com­ing to­geth­er to help oth­ers.”

Down­ing Street has said John­son re­mains in charge of the gov­ern­ment — al­though for­eign Sec­re­tary Do­minic Raab will chair the gov­ern­ment’s emer­gency COVID-19 meet­ing on Mon­day.

John­son’s preg­nant fi­ancée, Car­rie Symonds, said she had spent the past week in bed with symp­toms of Covid-19, but said is feel­ing stronger and is “on the mend.”

Scot­land’s chief med­ical of­fi­cer Cather­ine Calder­wood — one of the cadre of law­mak­ers charged with urg­ing the pub­lic to stay at home to save lives and pro­tect the Na­tion­al Health Ser­vice — has re­signed af­ter pic­tures of her fam­i­ly trip to a sec­ond home dur­ing the lock­down were pub­lished.

“I am deeply sor­ry for my ac­tions and the mis­takes I have made,” she said in a state­ment.

Bill Gates will con­tribute bil­lions to Covid-19 vac­cine de­vel­op­ment

Bill Gates, one of the rich­est peo­ple in the world, said the Bill and Melin­da Gates Foun­da­tion will spend bil­lions to fund the con­struc­tion of fac­to­ries for the most promis­ing vac­cine ef­forts, in an in­ter­view with co­me­di­an Trevor Noah on Thurs­day. The Foun­da­tion has al­ready com­mit­ted $125 mil­lion ef­fort to iden­ti­fy and de­vel­op treat­ments to fight the virus.

More drug de­vel­op­ers join the race to de­vel­op a Covid-19 treat­ment 

  • AI drug dis­cov­ery com­pa­ny Healx is us­ing its plat­form to de­vel­op drug com­bi­na­tions from ap­proved drugs, in a bid to si­mul­ta­ne­ous­ly tar­get dif­fer­ent as­pects of Covid-19 pathol­o­gy.
  • XBiotech and the non-prof­it Bio­Bridge Glob­al have said they are join­ing forces to par­tic­i­pate in an FDA in­ves­ti­ga­tion­al pro­gram for US blood cen­ters to be­gin col­lect­ing and dis­trib­ut­ing con­va­les­cent plas­ma from in­di­vid­u­als who have re­cov­ered from Covid-19. XBiotech has de­vel­oped an an­ti­body test to iden­ti­fy those in­di­vid­u­als, while a sub­sidiary of Bio­Bridge will col­lect plas­ma from these donors.

Pfiz­er joins big drug­mak­ers in of­fer­ing funds to com­bat the glob­al ef­fort against Covid-19

Pfiz­er has com­mit­ted $40 mil­lion in med­ical and char­i­ta­ble cash grants to ad­dress the needs of part­ners who are work­ing to slow the spread of the virus with­in com­mu­ni­ties, it said on Mon­day. The com­pa­ny joins fel­low drug­mak­ers such as Am­gen, As­traZeneca, and Take­da in mak­ing do­na­tions in cash or equip­ment.

An­i­mals to hu­mans to an­i­mals again

It may be un­clear how the SARS-CoV-2 virus was con­tract­ed by hu­mans in Chi­na, but over the week­end a tiger at New York’s Bronx Zoo test­ed pos­i­tive for the virus, re­port­ed­ly via a zoo em­ploy­ee who was asymp­to­matic.

Na­dia, a 4-year-old Malayan tiger that test­ed pos­i­tive, was screened for Covid-19 af­ter de­vel­op­ing a dry cough along with three oth­er tigers and three li­ons, said the Wildlife Con­ser­va­tion So­ci­ety, which man­ages the zoo, in a state­ment. All of the cats are ex­pect­ed to re­cov­er, it added.

Ad­di­tion­al re­port­ing by Ja­son Mast.

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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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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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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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.

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.

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.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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