Joseph Kim (Andrew Harnik/AP Images)

In­ovio's long­time CEO is out as Covid vac­cine lag­gard throws in the tow­el on PhI­II, piv­ots to boost­er

Joseph Kim, the long­time CEO who’s be­come al­most syn­ony­mous with In­ovio, is leav­ing the be­lea­guered com­pa­ny.

Jacque­line Shea

Step­ping down to make room for Jacque­line Shea — who first joined In­ovio as COO in 2019 — Kim leaves be­hind a lega­cy of bois­ter­ous claims and promis­es about DNA vac­cines over decades and a habit of cap­i­tal­iz­ing on pan­demics but no ap­proved prod­uct to show for it.

Shea will be over­see­ing a change in di­rec­tion as In­ovio, a lag­gard in the Covid-19 vac­cine race, shut­ters a Phase III tri­al in fa­vor of a boost­er strat­e­gy.

Board chair­man Si­mon Ben­i­to praised Shea, who’s held po­si­tions at Emer­gent and man­aged tu­ber­cu­lo­sis vac­cine projects at a non­prof­it, for her tech­ni­cal ex­per­tise. Since March 2019 she’s been over­see­ing every­thing from man­u­fac­tur­ing and com­mer­cial to busi­ness de­vel­op­ment and al­liance man­age­ment.

“We look for­ward to Dr. Shea tak­ing the helm dur­ing a par­tic­u­lar­ly chal­leng­ing pe­ri­od in IN­OVIO’s his­to­ry,” he said.

Chal­leng­ing, per­haps, be­cause the biotech is now fac­ing de­lays in not just the Covid ef­fort but al­so a cer­vi­cal can­cer drug af­ter the FDA told ex­ecs that its on­go­ing Phase III tri­al would not be enough to sup­port ap­proval.

In­ovio shares $INO — no stranger to ris­es and falls as Kim nav­i­gat­ed in and out of hype and bust — have gone down more than 60% over the past year, and dropped an­oth­er 18.88% in pre-mar­ket trad­ing Wednes­day to $2.49.

On the Covid front, In­ovio said it will now fo­cus on test­ing INO-4800 as a boost­er to oth­er vac­cines (mak­ing it a “het­erol­o­gous” boost­er) rather than a pri­ma­ry se­ries vac­cine op­tion.

Here’s Shea on In­ovio’s Q1 call, just hours af­ter she was of­fi­cial­ly put in charge:

As we shift to pri­or­i­tize our het­erol­o­gous boost strat­e­gy, we will dis­con­tin­ue our glob­al Phase III IN­NO­VATE tri­al. This de­ci­sion re­flects emerg­ing glob­al da­ta that in­di­cates a low­er in­stance of se­vere COVID-19 cas­es caused by the Omi­cron vari­ant [In­audi­ble], which would ne­ces­si­tate a sub­se­quent in­crease in tri­al size and costs for In­no­vate to ob­tain an ef­fi­ca­cy read­out against se­vere dis­ease.

Even though Kim was among a se­lect group of CEOs who met with Pres­i­dent Don­ald Trump ear­ly in the pan­dem­ic to dis­cuss the de­vel­op­ment of vac­cines and ther­a­peu­tics against the nov­el coro­n­avirus, In­ovio con­sis­tent­ly strug­gled to make progress, held back at var­i­ous points by a stand­off with its con­tract man­u­fac­tur­er, a clin­i­cal hold, slow en­roll­ment and a with­draw­al of fund­ing. With the ex­cep­tion of No­vavax (whose vac­cine is at least au­tho­rized in mul­ti­ple oth­er coun­tries), every oth­er com­pa­ny, from Pfiz­er to Gilead, has steered prod­ucts to the mar­ket.

Mean­while, In­ovio re­vealed it’s al­so chang­ing di­rec­tions with VGX-3100, an ex­per­i­men­tal treat­ment for HPV-16/18-as­so­ci­at­ed cer­vi­cal high-grade squa­mous in­traep­ithe­lial le­sions. The FDA ad­vised the com­pa­ny to con­duct an­oth­er tri­al to con­firm its hy­poth­e­sis that the im­munother­a­py works for a bio­mark­er-se­lect­ed sub­group.

True to its spir­it, the com­pa­ny is al­so de­vel­op­ing a slate of oth­er pro­grams to treat can­cer and a rare res­pi­ra­to­ry dis­ease, among oth­ers.

Amid the pipeline shuf­fle and a “repri­or­i­ti­za­tion” of re­sources, CFO Pe­ter Kies said on the Q1 call that In­ovio an­tic­i­pates a “re­duc­tion in our month­ly burn” — with up­dates to come lat­er in the sum­mer.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.