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.

CDC’s Robert Redford, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA, ques­tions need to length­en process

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

The mi­cro-cap that tapped a mask-skep­tic con­gress­man for their Covid DSMB is ap­ply­ing for an EUA. Their ev­i­dence? 21 pa­tients

NeuroRx, the tiny biotech that came under fire last week after Politico reported they selected a congressman and two other acquaintances of the CEO to supervise their Covid-19 drug trial, announced today that they will ask the FDA to authorize their drug based on the results of just 21 patients.

Such an application would test the agency’s standards of evidence for an EUA, which have already come under scrutiny after controversial authorizations for convalescent plasma and hydroxychloroquine. The only other company to discuss their intention to file for an EUA, Eli Lilly, did so after results came back from a randomized control study testing their antibody in over 450 patients.