Inovio’s founding CEO, Joseph Kim, Ph.D., is throwing in the towel after a bumpy couple of years trying to join the COVID vaccine market. He will be replaced by Jacqueline Shea, Ph.D., who will pick up where he left off during this “particularly challenging period in Inovio’s history.”
Those comments from Board Chair Simon Benito are a bit of an understatement. Inovio started off as a hopeful responder to the COVID-19 pandemic with the promise of a stable, easy to administer DNA vaccine that could be manufactured quickly to respond to the global health crisis.
But that promise never came to be. Inovio ran into a number of challenges that led to delays, including a 14-month clinical hold. In March, the company announced yet another setback after results showed the shot couldn’t stand up to the omicron variant. Enrollment in a phase 3 trial was paused.
Investors were not pleased with the executive change, as shares plummeted 30% as the markets opened Wednesday morning, from a previous close of $2.49 to $1.76 as of 9:51 a.m. ET.
Kim, Inovio’s co-founder, will also relinquish his board seat. Later this month, the board intends to name him as a director of the board.
As new CEO, Shea will have a tough job to take on as the company moves towards a new strategy. In addition to announcing the CEO transition after market Tuesday, Inovio also previewed a new plan to pivot towards developing INO-4800 as a booster instead. The company is not alone, as late entrants such as Sanofi and GlaxoSmithKline have done the same with their candidate.
The phase 3 INNOVATE trial will be discontinued due to a lower rate of severe COVID-19 cases that would have required a much larger patient population—as well as swelling costs for Inovio to conduct the study. The company now thinks boosters are the best way forward, according to a Tuesday earnings release.
“While we have many challenges to face, I believe strongly in the potential of our DNA medicines technology and continue to be inspired by Inovio’s talented and dedicated team,” Shea said in a statement. “I look forward to reshaping the future of Inovio and advancing our efforts across multiple therapeutic areas with the potential to improve the lives of patients globally.”
In a statement provided to Fierce Biotech, spokesman Jeff Richardson said Shea “has a complete understanding of our platform and of Inovio.”
“She understands what is needed to fulfill the vision of the company,” Richardson said. “She is fully committed to the science of DNA medicines and has the respect of the entire company.”
Inovio is working with Advaccine on the booster program, which will still feature the original INO-4800 vaccine. Preliminary data have shown that giving the shot after a primary series of an approved vaccine resulted in an increase in T-cell immune response.
Shea has been with Inovio since March 2019 after serving as CEO of the vaccine nonprofit organization Aeras. Her previous role was chief operating officer, where she was responsible for Inovio’s manufacturing, commercial, business development, project and alliance management operations, according to Richardson.
Under her direction, Richardson said the company will continue forth with its DNA medicines platform, with a focus on infectious diseases, cancer and HPV-associated diseases.