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.
Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.
Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.
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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.
With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.
The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.
A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.
Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.
According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.
Moderna’s rapid fire development of its hugely successful mRNA vaccine for Covid saved lives, changed the vaccine industry forever and made CEO Stéphane Bancel a billionaire. But perhaps the sweetest reward came this week, when Bancel was named a Chevalier — basically knighted — by the president of France.
Prestigious European titles like this are rare in biopharma, but not unknown, as AstraZeneca’s Mene Pangalos could tell you after being knighted by the Queen, named on the honors list in 2020 for his contribution to science.
AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.
The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.
Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.
This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.
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Sanofi CEO Paul Hudson has made clear his intention to develop new rare disease drugs and broaden his company’s offerings. That effort leaped forward on Friday with the EMA’s signing off on the company’s — and the EU’s — first drug to treat the non-central nervous system manifestations of the rare and debilitating Niemann-Pick disease.
The enzyme replacement therapy, developed to replace patients’ deficient or defective enzyme, known as acid sphingomyelinase, was first developed by Genzyme, which Sanofi acquired for more than $20 billion in 2011. That acquisition has also helped Sanofi pull in sales in the field of MS.
Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas
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