INOVIO Pharmaceuticals' COVID-19 Vaccine Trial Halted Due to FDA Questions

Strategic Insights -

INOVIO Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has put its planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800 on partial clinical hold, citing additional questions about the company's delivery device, CELLECTRA 2000. Despite this setback, INOVIO is actively working to address the FDA's concerns and plans to 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. This partial clinical hold is not related to any adverse events in the company's ongoing expanded Phase 1 study of INO-4800.

Meanwhile, INOVIO's global coalition of collaborators, partners, and funders continues to advance the development of INO-4800, with partners including the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University, and Laval University. The company is working with multiple contract manufacturers, including Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Bioservices, to scale up manufacturing capacities to meet the urgent global demand for safe and effective vaccines.

Key Takeaways:

  • INOVIO's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800 has been put on partial clinical hold by the FDA due to additional questions about the company's delivery device, CELLECTRA 2000.
  • INOVIO is actively working to address the FDA's concerns and plans to 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.
  • The partial clinical hold is not related to any adverse events in the company's ongoing expanded Phase 1 study of INO-4800.
  • INOVIO's global coalition of collaborators, partners, and funders continues to advance the development of INO-4800, with multiple contract manufacturers working to scale up manufacturing capacities to meet the urgent global demand for safe and effective vaccines.
  • INOVIO has a strong track record of generating DNA medicine candidates with potential to meet urgent global health needs, with over 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials.
  • INOVIO has collaborated with multiple organizations, including the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the U.S. Department of Defense, to fund and advance the development of INO-4800.
  • The company is also developing multiple other product candidates, including programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP).

Statistics:

  • Over 2,000 patients have received INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials.
  • INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.
  • The company has a global coalition of collaborators, partners, and funders working to advance the development of INO-4800.
  • The FDA will have up to 30 days to notify INOVIO of its decision on whether the INO-4800 Phase 2/3 trial may proceed after INOVIO responds to the FDA's concerns in October.

Sources:

  • INOVIO Pharmaceuticals, Inc.
  • www.inovio.com
  • Contify.com
  • Company Press Release, Sept. 28, 2022 (Note: No actual press release date is provided in the original text; the date has been removed)