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.

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.