Inovio Pharmaceuticals Inc (INO)

[Lakers_w]

On positive interim readout of 1H22 RRP, Ino could sign a Collaboration and Licensing Agreement with upfront money and milestone payments before starting P3.
1/7/22 Overall Status: Recruiting => Active, not recruiting

The open-label, multicenter INO-3107 Phase 1/2 trial is currently open to enrollment to recruit up to 63 subjects and will evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in subjects who have required at least two surgical interventions per year for the past three years for the removal of associated papilloma(s). For this study, adult subjects will first undergo surgical removal of their papilloma(s) and then receive four doses of INO-3107, one every three weeks. The primary efficacy endpoint will be a doubling or more in the time between surgical interventions following the first dose of INO-3107 relative to the frequency prior to study therapy.

RRP is a rare disease caused by the human papillomavirus (HPV) types 6 and 11 infections, a condition that causes non-cancerous tumor growths leading to life-threatening airway obstructions. The disease is currently incurable and is mostly treated by surgery, which temporarily restores the airway. The majority of tumors are recurring, necessitating repeated surgery and severely impacting the quality of life for those living with the disease. Earlier this year, the US Food and Drug Administration (FDA) granted INO-3107 Orphan Drug Designation.

11/23/21 INOVIO Announces Dosing of First Subject in Phase 1/2 Clinical Trial for INO-3107, its DNA Medicine to Treat a Rare Disease Recurrent Respiratory Papillomatosis (RRP)

“In fact, we think VGX-3100 (HPV program) and INO-5401 (GBM program) will be the main value drivers for Inovio moving forward, and while we don’t expect any catalysts for these programs in 1H22, we expect readouts for INO-4500 in Lassa fever and INO-3107 in RRP in 1H22 to further de-risk the platform and add momentum to the story,” he added.

Dr. Ted Mau, Assistant Professor of Otolaryngology, Head and Neck Surgery, at UT Southwestern Medical Center, and lead investigator for INOVIO's RRP Phase 1/2 clinical trial, said, "As a surgeon, I have had patients who have required dozens of surgeries and are looking at many more during their lifetimes. This new systemic therapy is specific for RRP and has the potential to meaningfully alter the treatment paradigm for patients living with this disease."

https://clinicaltrials.gov/ct2/history/NCT04398433?A=20&B=21&C=merged#StudyPageTop