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.

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.

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.

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.