Jacqueline Shea, Inovio CEO

As the pan­dem­ic high wanes, In­ovio chops head­count again while chas­ing Covid win

The Jacque­line Shea era at In­ovio will start with a sweep­ing re­or­ga­ni­za­tion.

Still ea­ger to prove that its DNA plas­mid tech­nol­o­gy will yield a Covid-19 boost­er and a vac­cine for HPV, among oth­er things, the biotech says it’s down­siz­ing to re­duce op­er­a­tional ex­pens­es and ex­tend its cash run­way in­to the third quar­ter of 2024.

As a re­sult, 18% of its em­ploy­ees — and 86% of the con­trac­tors — will be laid off. Based on In­ovio’s an­nu­al re­port not­ing that it em­ployed 317 peo­ple as of Feb­ru­ary, that would trans­late to about 57 full-time staffers be­ing let go.

“By dri­ving op­er­a­tional ef­fi­cien­cies through­out our or­ga­ni­za­tion, we are fo­cused on ad­vanc­ing our lead pipeline can­di­dates to­ward com­mer­cial­iza­tion and op­ti­miz­ing our chances of suc­cess,” Shea said in a state­ment.

It’s not the first time In­ovio has had to hun­ker down. Un­der Shea’s pre­de­ces­sor, found­ing CEO Joseph Kim, the 40-year-old biotech had ded­i­cat­ed it­self to mul­ti­ple can­di­dates — draw­ing crit­i­cism of be­ing a “John­ny-on-the-spot” — none of which came near ap­proval. In 2019, Kim vowed to cre­ate “a more ef­fi­cient or­ga­ni­za­tion with greater fi­nan­cial flex­i­bil­i­ty and a longer run­way” when he slashed the work­force by 28% and axed a suite of ear­ly-stage pro­grams.

De­spite its failed ef­forts at de­vel­op­ing DNA vac­cines for pre­vi­ous in­fec­tious dis­ease out­breaks such as MERS and Ebo­la, In­ovio still man­aged to seize the op­por­tu­ni­ty amid the Covid-19 pan­dem­ic to pro­mote it­self. Kim land­ed a seat at the ta­ble with for­mer Pres­i­dent Don­ald Trump, along­side oth­er es­tab­lished vac­cine mak­ers. At one point in 2020, its shares $INO swelled to near $30, par­tial­ly ex­plain­ing how In­ovio grew its ranks again af­ter the 2019 lay­offs left the head­count at 200.

It now sits at just be­low $2 per share.

To this day, In­ovio’s Covid shot, INO-4800, re­mains in clin­i­cal tri­als. The com­pa­ny has said it would fo­cus on test­ing INO-4800 as a boost­er to oth­er vac­cines (mak­ing it a “het­erol­o­gous” boost­er) rather than a pri­ma­ry se­ries vac­cine op­tion. Da­ta read­outs for its HPV pro­grams are al­so ex­pect­ed soon.

The pipeline al­so fea­tures pro­grams in can­cer and oth­er in­fec­tious dis­eases, al­though Shea not­ed that her team is work­ing on “im­prov­ing our pri­or­i­ti­za­tion process­es.”

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

Endpoints Premium

Premium subscription required

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

(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Al Sandrock, Voyager Therapeutics CEO

Al San­drock prunes his post-Bio­gen voy­age with sim­i­lar fo­cus on ALS

Al Sandrock is narrowing the focus of Voyager Therapeutics, concentrating on CNS diseases that were the hallmark of his time leading R&D at Biogen, including an emphasis on a familial form of ALS for which his former employer is getting a speedy review at the FDA.

Less than six months into his journey as CEO at Voyager, Sandrock is focusing the preclinical pipeline on Alzheimer’s disease, GBA1 Parkinson’s disease and SOD1 amyotrophic lateral sclerosis, the rare form of ALS for which the FDA will decide whether to approve Biogen’s tofersen by Jan. 25, 2023.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

David Hallal (L) and George Daley (Hallal photo: Bertrand Guay/AFP via Getty Images)

David Hal­lal's El­e­vate­Bio launch­es new com­pa­ny to 'dis­rup­t' off-the-shelf cell ther­a­py, but pro­vides few oth­er de­tails

David Hallal’s ElevateBio is launching a new company Thursday as it looks to continue making its mark in the cell and gene therapy spaces. But Hallal is also keeping his cards close to the vest, preferring to toe the line between bombast and mystique rather than going all-in in one direction.

The new company comes out of a partnership with Boston Children’s Hospital and research from George Daley, the dean of Harvard Medical School. The triumvirate claims to have found a way to design better off-the-shelf cell therapies using new methods discovered in Daley’s Boston Children’s Hospital lab (Harvard is not involved in the collaboration).

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.