Tucked in the Q4 earnings release, Inovio Pharmaceuticals Inc (NASDAQ: INO) has paused enrollment for an ongoing INNOVATE Phase 3 trial of its lead COVID-19 vaccine candidate.
- The decision follows as the shot showed significantly lower antibody levels against the omicron variant in lab testing.
- The vaccine, INO-4800, maintained a robust T-cell response in the lab tests, leading Inovio to plan changes to the trial design.
- T-cells are a vital part of the immune system's second line of defense.
- The Company plans to seek regulatory approval to change the study's main goal to "prevention of severe disease due to COVID-19" from the earlier goal of "prevention of virologically confirmed COVID-19 disease."
- An independent data safety monitoring board recommended that Inovio pause enrollment to reflect Omicron's potential impact on the trial.
- As a result, interim efficacy data from the trial will not be available in 1H of 2022 as previously expected.
- In November, Inovio resumed the late-stage trial of its vaccine in the U.S. after 14 months on clinical hold.
- The FDA in September 2020 put the study on hold as it sought more information, including details on a delivery device used to inject genetic material into cells.
- Inovio held $401.3 million in cash and cash equivalents and short-term investments at the end of 2021.
- Price Action: INO shares are down 11.8% at $2.86 during the market session on the last check Wednesday.
Read at Benzinga