Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

In­ovio was one of the first vac­cine de­vel­op­ers to snag at­ten­tion for a jab that their ex­ecs said promised to end the Covid-19 pan­dem­ic. Us­ing their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while ri­vals are rac­ing to the fin­ish line with am­bi­tious plans to make vast quan­ti­ties of their vac­cines with bil­lions of dol­lars of deals, In­ovio is still stuck at the start­ing line on man­u­fac­tur­ing.

The biotech — which has yet to de­vel­op a sin­gle ap­proved prod­uct in 4 decades — says it cur­rent­ly has been stymied by a stand­off with its longterm con­tract man­u­fac­tur­er. And In­ovio filed a law­suit to free it­self from the re­la­tion­ship and move on to new part­ners who can make hun­dreds of mil­lions of dos­es — if it pass­es muster.

The prob­lem, In­ovio claims in its law­suit, is that a Ko­re­an-owned com­pa­ny called VGXI, which has long been re­spon­si­ble for mak­ing the batch­es of vac­cines the biotech us­es in tri­als, can’t make the vac­cine in com­mer­cial quan­ti­ty and re­fus­es to trans­fer the tech­nol­o­gy re­quired to oth­ers who can — de­spite be­ing con­trac­tu­al­ly bound to do so.

VGXI is build­ing a plant, the biotech adds, but that won’t come on­line un­til 2022 — an eter­ni­ty in pan­dem­ic tim­ing, es­pe­cial­ly as a group of vac­cine mak­ers who have man­u­fac­tur­ing ca­pac­i­ty ei­ther in-house or con­tract­ed or both are rac­ing to start pro­vid­ing vac­cines as ear­ly as this fall, with bil­lions of dos­es pos­si­ble next year.

In­ovio is ask­ing a judge for dam­ages as well as an or­der to shift the tech to new ven­dors.

While VGXI, based in The Wood­lands out­side of Hous­ton, TX, hasn’t filed a re­sponse yet, In­ovio in­clud­ed sev­er­al let­ters from their COO, Dorothy Pe­ter­son, say­ing that the man­u­fac­tur­ing tech in­volved is pro­pri­etary to her com­pa­ny. One oth­er let­ter from Pe­ter­son to a com­pa­ny called Ol­o­gy, which had sought to make the vac­cine for In­ovio, de­mand­ed that they stop us­ing tech that be­longed to VGXI.

Pe­ter­son al­leged that In­ovio vi­o­lat­ed their sup­ply agree­ment by go­ing to oth­er man­u­fac­tur­ers — which In­ovio de­nied — but of­fered to work out a new mas­ter sup­ply agree­ment to take its place.

Like oth­er com­pa­nies that jumped in­to the Covid-19 race, In­ovio has seen its stock price gy­rate high­er on spec­u­la­tion over which com­pa­ny will be a suc­cess. Op­er­a­tion Warp Speed out of the White House re­port­ed­ly is set on as­sist­ing a small group of vac­cine de­vel­op­ers, like Mod­er­na. But In­ovio wasn’t men­tioned.

To­day, the biotech’s stock is down about 5%, but it’s still rough­ly triple the mark it trad­ed at in late Feb­ru­ary, when the out­break went glob­al.

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

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.5 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Covid-19 roundup: Con­tro­ver­sy around colchicine per­co­lates af­ter study fail­ure; As­traZeneca's meet­ing with EU was 'con­struc­tive,' but did­n't solve much

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

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'Bank of BAR­DA': In­ves­ti­ga­tion finds HHS raid­ed pan­dem­ic pre­pared­ness funds for decade be­fore Covid-19

Before 2020, few Americans had ever heard of the Biomedical Advanced Research and Development Authority, BARDA, or its far-flung mission to stave off future pandemics and bio-threats. Allegedly, that made it a pretty good target for others in HHS who needed to scavenge some extra cash.

Over the last decade, other HHS officials raided BARDA’s coffers and misappropriated millions of dollars that Congress had earmarked to fund vaccine research and prepare for public health emergencies like Covid-19, according to a new report from the US Office of Special Counsel, which investigated a whistleblower report.

Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.