Inovio's COVID-19 Vaccine Trial Paused Over FDA Questions

Strategic Insights -

Inovio Pharmaceuticals' development of its COVID-19 vaccine candidate, INO-4800, has hit a roadblock as the U.S. Food and Drug Administration (FDA) has put the Phase II/III trial on partial clinical hold, citing additional questions about the vaccine and its delivery device, the Cellectra 2000. This move comes as the company's rivals, such as Moderna, Pfizer, and AstraZeneca, have begun late-stage studies of their own COVID-19 vaccine candidates. The FDA's actions have triggered a trading pause of Inovio shares, despite the company's announcement of positive interim data from the Phase I trial of INO-4800 in June.

Key Takeaways:

  • The FDA has put Inovio's Phase II/III trial of its COVID-19 vaccine candidate, INO-4800, on partial clinical hold due to additional questions about the vaccine and its delivery device, the Cellectra 2000.
  • Inovio's development timeline is lagging behind its rivals, including Moderna, Pfizer, and AstraZeneca, which have begun late-stage studies of their COVID-19 vaccine candidates.
  • Despite the hold, Inovio's Phase I trial of INO-4800 showed positive interim data, with the vaccine appearing to be both safe and well-tolerated with no serious adverse events at Week 8.
  • The company plans to address the FDA's questions and respond in October, after which the FDA will have up to 30 days to notify Inovio of its decision on whether the trial may proceed.
  • Inovio stock has closed at $US16.94 per share on Friday, up almost 400% year-to-date, despite the trading pause.
  • Analyst Jason McCarthy of Maxim Group has upgraded the stock to Buy from Hold, believing that shares have been oversold.

Statistics:

  • Total number of COVID-19 cases as of Tuesday: 33,273,720
  • Total number of COVID-19 fatalities as of Tuesday: 1,000,825
  • Timeframe for Inovio to respond to the FDA's questions: October
  • Timeframe for the FDA to notify Inovio of its decision on whether the trial may proceed: up to 30 days after Inovio's response
  • Percent change in Inovio stock price year-to-date: almost 400%

Sources:

  • Inovio Pharmaceuticals' announcement of positive interim data from the Phase I trial of INO-4800
  • Bloomberg report on Inovio's development timeline and the FDA's questions
  • Business Insider Australia article on the FDA's actions and Inovio's stock price