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.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.