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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.