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

2022-05-21 17:25:25 By : Mr. Frank Wong

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

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.

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

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The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

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According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Moderna’s rapid fire development of its hugely successful mRNA vaccine for Covid saved lives, changed the vaccine industry forever and made CEO Stéphane Bancel a billionaire. But perhaps the sweetest reward came this week, when Bancel was named a Chevalier — basically knighted — by the president of France.

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AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

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Sanofi CEO Paul Hudson has made clear his intention to develop new rare disease drugs and broaden his company’s offerings. That effort leaped forward on Friday with the EMA’s signing off on the company’s — and the EU’s — first drug to treat the non-central nervous system manifestations of the rare and debilitating Niemann-Pick disease.

The enzyme replacement therapy, developed to replace patients’ deficient or defective enzyme, known as acid sphingomyelinase, was first developed by Genzyme, which Sanofi acquired for more than $20 billion in 2011. That acquisition has also helped Sanofi pull in sales in the field of MS.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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