Key Takeaways
- Inovio Pharmaceuticals has laid off staff and shifted focus to its primary candidate, INO-3107, amid FDA concerns.
- INO-3107 is aimed at treating recurrent respiratory papillomatosis caused by HPV, with an FDA decision expected by October 2026.
- The FDA raised potential issues with INO-3107’s eligibility for accelerated approval, prompting a meeting with Inovio to discuss concerns.
Company Restructuring Amid FDA Review
Inovio Pharmaceuticals has announced a series of layoffs while refocusing its efforts on the development of INO-3107, its key candidate for treating recurrent respiratory papillomatosis, a rare disease linked to certain strains of human papillomavirus (HPV). As of March 11, the company had reduced its workforce from 134 to 112 employees, with the layoffs targeting roles that do not directly support the approval of INO-3107.
INO-3107 is designed to stimulate T cells to combat HPV-infected cells, targeting tumors in the vocal cords that can lead to life-threatening airway blockages. Inovio filed for accelerated approval of INO-3107 in December 2023, with the FDA set to make a decision by October 30, 2026. However, the FDA has expressed reservations about the candidate’s qualifications for accelerated approval.
In its response to the FDA, Inovio leaned on its belief that INO-3107 offers substantial therapeutic benefits compared to existing treatments. The agency’s letter noted the preliminary conclusion that the company may not have provided enough evidence to justify accelerated approval, raising concerns about INO-3107’s eligibility. Despite these challenges, the FDA has agreed to meet with Inovio to further discuss these issue, although the date for this meeting has not been confirmed.
The scrutiny surrounding INO-3107’s review is being led by Dr. Vinay Prasad, the outgoing director of the Center for Biologics Evaluation and Research. His tenure has been marred by criticism due to the rejection of multiple rare disease therapies, which have often contradicted earlier guidelines provided to the companies seeking approval.
Inovio initially received approval for accelerated consideration of INO-3107 in October 2023 during the Biden administration. At that time, the FDA indicated that a single-arm, phase 1/2 trial could support the approval application. This stands in contrast to the experience of another biotech firm, Precigen, whose similar candidate eventually received approval under the name Papzimeos in August 2025.
Engagement with the FDA remains crucial for Inovio as it navigates this complex regulatory landscape while striving for approval of its promising but currently challenged therapy.
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