Inovio says no-go on phase 3 cervical lesion program after clinical setback, lays off 30% of staff

Inovio is making its third round of layoffs in 13 months. Facing a long path to approval, the biotech has stopped its cervical lesion program to focus on its most promising, closest-to-market options, putting 58 people out of work in the process. 

Pennsylvania-based Inovio has spent the past 18 months adapting to the unraveling of its COVID-19 vaccine program. Founding CEO Joseph Kim, Ph.D., jumped ship in May 2022. Two months later, the new CEO, Jacqueline Shea, Ph.D., laid off 55 people, an 18% reduction in full-time head count. Pink slips rained down again in January, when Inovio parted company with 24 staffers after a setback to its pipeline.  

Eight months later, Inovio is repeating the cycle. The details have changed, but the outline is the same: Inovio is laying off staff because of a setback to a key pipeline program. This time around, the biotech is reducing its head count by 30% in relation to its decision to stop work on VGX-3100 in one indication. 

In March, VGX-3100, a DNA vaccine encoding human papillomavirus genes, failed to improve lesion regression and viral clearance in a biomarker-based subpopulation of women with high-grade squamous intraepithelial lesions, abnormal cells that form on the cervix and can turn cancerous. Further analysis of the data has persuaded Inovio to stop investing in the indication.

“The biomarker did not perform as expected in REVEAL2. An error analysis of why this occurred indicates that a significant amount of additional work would need to be done to further develop the biomarker before it could be used prospectively in any new phase 3 trials,” Michael Sumner, chief medical officer at Inovio, told investors on a second-quarter results conference call Wednesday.

Facing the biomarker work, plus the need to conduct one or more pivotal trials before seeking approval, Sumner concluded that advancing VGX-3100 in the indication “would require significant investments and lead to a very long development timeline.” Inovio decided there are better ways to spend its money.

Attention now turns to INO-3107, a potential recurrent respiratory papillomatosis treatment that Inovio aims to move into phase 3 in the first quarter of next year. Inovio is racing against Precigen, which this week told investors the FDA will accept its ongoing phase 1/2 single arm study as a pivotal trial. Precigen is scheduled to wrap up its trial in March.

Inovio is yet to commit to a timeline for completing its trial but has bought itself more time through the latest layoffs. The biotech now expects its cash to fund work into the third quarter of 2025, compared to the first quarter of 2025 under the prior spending plan. Inovio plans to use some of its money to explore the use of VGX-3100 in anal lesions and is looking to partner other programs.