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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

David Kessler testifies during a Senate hearing in May (Jim Lo Scalzo/Pool via AP Images)

Biden's fight with Mod­er­na over pro­vid­ing vac­cines for the poor­est coun­tries in­ten­si­fies

With about $10 billion in taxpayer funds invested in Moderna so far, it would seem that the company would be more understanding of pleas from President Joe Biden and the federal government to provide more vaccine doses to low- and middle-income countries.

But the Biden-Moderna feud over supplying the world with doses of mRNA vaccines is now spilling into the public, with Biden’s chief science officer of the government’s Covid-19 response David Kessler explaining the details in an online panel discussion moderated by Yale law professor Amy Kapczynski on Wednesday.

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