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.
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.