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.

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