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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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