Covid-19 roundup: In­ovio fi­nal­ly gets PhII rolling — but there's still a clin­i­cal hold; Low cost vac­cine en­ters PhI/II in In­dia

In­ovio has man­aged to con­vince the FDA to sign off on a Phase II tri­al of its Covid-19 vac­cine. But the Phase III por­tion re­mains clamped by a par­tial clin­i­cal hold more than a month af­ter it was first im­posed.

The lit­tle biotech said that reg­u­la­tors still have re­main­ing ques­tions about the de­vice that will be used to de­liv­er its can­di­date, INO-4800, di­rect­ly in­to the skin. The plan is “to re­solve the re­main­ing de­vice ques­tions dur­ing the con­duct of Phase 2 seg­ment and pri­or to the start of the Phase 3 seg­ment of the tri­al,” ac­cord­ing to a state­ment.

CEO Joseph Kim gushed over the news with char­ac­ter­is­tic fer­vor, hail­ing the ini­ti­a­tion of Phase II as a “piv­otal mile­stone” and high­light­ing the fact that the De­part­ment of De­fense will fund the tri­al.

But over 40 years in the vac­cine busi­ness — with no ap­proved prod­ucts to show for it — In­ovio has con­sis­tent­ly fall­en short of its promis­es. Hav­ing start­ed out ear­ly with a DNA vac­cine that Kim said took on­ly 3 hours to come up, nabbed a grant from CEPI and lat­er got­ten the DoD on board with $71 mil­lion, the com­pa­ny had promised that a late-stage study should be set to go in the sum­mer.

In­stead, a big­ger le­gal feud with its con­tract man­u­fac­tur­er dragged In­ovio way be­hind the fron­trun­ning pack of big-name play­ers like Pfiz­er/BioN­Tech, Mod­er­na, As­traZeneca and J&J. Then came the dis­clo­sure, late Sep­tem­ber, that the FDA wasn’t sure its de­liv­ery de­vice is quite ready for prime time.

In­ovio said the FDA has now re­viewed enough non-clin­i­cal da­ta, de­vice in­for­ma­tion and in­ter­im Phase I safe­ty and im­muno­genic­i­ty as well as tri­al plans to give the green light.

The Phase II por­tion will en­roll around 400 par­tic­i­pants in the US as part of a dose-con­firm­ing ex­er­cise.

Like Pfiz­er/BioN­Tech and Mod­er­na — both of which pro­nounced stel­lar vac­cine ef­fec­tive­ness with­in the past few days — In­ovio’s vac­cine will be giv­en in a two-dose reg­i­men. But INO-4800 promis­es to do away with the frozen cold chain re­quire­ments, re­main­ing sta­ble at room tem­per­a­ture for more than a year.

If it proves ef­fi­ca­cious in tri­als, that is.

Shares of the Ply­mouth Meet­ing, PA-based com­pa­ny, which were ham­mered when the par­tial hold was dis­closed, climbed 12.92% in pre-mar­ket trad­ing.

In­di­an vac­cine mak­er kicks off tri­al for Bay­lor’s low-cost can­di­date

Years af­ter Pe­ter Hotez and his team at the Bay­lor Col­lege of Med­i­cine were forced to shelve a po­ten­tial vac­cine for SARS due to a lack of fund­ing, a new can­di­date they’ve de­vel­oped against SARS-CoV-2 is go­ing in­to the clin­ic.

Hy­der­abad-based Bi­o­log­i­cal E, which li­censed the sub­unit vac­cine from BCM Ven­tures, has start­ed a Phase I/II tri­al in In­dia, where the jab will be boost­ed by an ad­ju­vant from Dy­navax.

To be in­ject­ed in two in­tra­mus­cu­lar shots 28 days apart, the vac­cine can­di­date con­sists of the re­cep­tor bind­ing do­main of the spike pro­tein — rather than the whole spike pro­tein, which is the tar­get of both Pfiz­er/BioN­Tech and Mod­er­na’s in­oc­u­la­tions. In the new study, three dose lev­els will be test­ed among 360 healthy vol­un­teers be­tween 18 and 65 years old.

“This vac­cine rep­re­sents an ur­gent biotech­nol­o­gy in­no­va­tion for en­sur­ing health eq­ui­ty and com­bat­ing the COVID-19 pan­dem­ic,” said Hotez, dean of the Na­tion­al School of Trop­i­cal Med­i­cine at Bay­lor and co-di­rec­tor of Texas Chil­dren’s Hos­pi­tal Cen­ter for Vac­cine De­vel­op­ment.

Re­sults are ex­pect­ed by Feb­ru­ary.

Bay­lor be­gan work­ing with Bi­o­log­i­cal E back in Au­gust, when In­dia be­came the third-lead­ing na­tion in Covid-19 cas­es, to trans­fer the tech­nol­o­gy need­ed to scale up man­u­fac­tur­ing of its vac­cine with­in the coun­try. As the vac­cine is pro­duced us­ing a known yeast-based ex­pres­sion tech­nol­o­gy, the hope was the phar­ma com­pa­ny could lever­age its past ex­pe­ri­ence to push for­ward an af­ford­able vac­cine op­tion.

Naren­der Dev Man­te­na, a di­rec­tor of BioE Hold­ings who’s head­ing up the vac­cine ini­tia­tive, pre­vi­ous­ly said they ex­pect to make “sev­er­al hun­dred mil­lion dos­es avail­able an­nu­al­ly.”

Pfiz­er/BioN­Tech vac­cine like­ly to roll out in UK by Christ­mas

Britain will be ready to roll out the vac­cine de­vel­oped by Pfiz­er and BioN­Tech with­in two weeks, ac­cord­ing to health min­is­ter Matt Han­cock, re­it­er­at­ing a time­line he’s plot­ted in re­cent days.

“We’re work­ing very close­ly with the com­pa­ny,” he told BBC TV. “We’ll be ready to roll it out as soon as it comes, we’ll be ready from the first of De­cem­ber…, but more like­ly is that we may be able to start rolling it out be­fore Christ­mas.”

Pfiz­er and BioN­Tech have struck a deal to sup­ply the UK with 30 mil­lion dos­es of its mR­NA jab — vials that Han­cock has said he’s ready to fly in from Bel­gium if bor­der dis­putes arise due to Brex­it.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Biogen CEO Michel Vounatsos (via Getty Images)

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Pascal Soriot (AP Images)

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With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

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The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

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Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

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