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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

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.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

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.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

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.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.