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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

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'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Covid-19 roundup: As­pen to pro­duce gener­ic J&J vac­cine for Africa; First boost­ers for un­der-18-year-olds could come next week — re­port

After some ups and downs surrounding the manufacturing of J&J’s Covid-19 vaccine as the South African company’s site, Aspen Pharmacare has announced an agreement with the pharma to make and sell an Aspen-branded Covid-19 vaccine through the continent.

The agreement will expand the already-existing tech transfer and agreement to give Aspen the right to make vaccines from drug substance supplied by J&J, and sell the finished form under the name Aspenovax to public sector markets in Africa.

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Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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