Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Nov;133(11):3087-3093.
doi: 10.1002/lary.30749. Epub 2023 May 19.

Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11-Associated Recurrent Respiratory Papillomatosis

Ted Mau  1 , Milan R Amin  2 , Peter C Belafsky  3 , Simon R Best  4 , Aaron D Friedman  5 , Adam M Klein  6 , David G Lott  7 , Randal C Paniello  8 , Seth M Pransky  9 , Nabil F Saba  10 , Tamara Howard  11 , Michael Dallas  11 , Aditya Patel  11 , Matthew P Morrow  11 , Jeffrey M Skolnik  11
Affiliations
Clinical Trial

Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11-Associated Recurrent Respiratory Papillomatosis

Ted Mau et al. Laryngoscope. 2023 Nov.

Abstract

Objective: To evaluate the safety, immunogenicity, and efficacy of INO-3107, a DNA immunotherapy designed to elicit targeted T-cell responses against human papillomavirus (HPV) types 6 and 11, in adult patients with recurrent respiratory papillomatosis (RRP; NCT04398433).

Methods: Eligible patients required ≥2 surgical interventions for RRP in the year preceding dosing. INO-3107 was administered by intramuscular (IM) injection followed by electroporation (EP) on weeks 0, 3, 6, and 9. Patients underwent surgical debulking within 14 days prior to first dose, with office laryngoscopy and staging at screening and weeks 6, 11, 26, and 52. Primary endpoint was safety and tolerability, as assessed by treatment-emergent adverse events (TEAEs). Secondary endpoints included frequency of surgical interventions post-INO-3107 and cellular immune responses.

Results: An initial cohort of 21 patients was enrolled between October 2020 and August 2021. Fifteen (71.4%) patients had ≥1 TEAE; 11 (52.4%) were Grade 1, and 3 (14.3%) were Grade 3 (none treatment related). The most frequently reported TEAE was injection site or procedural pain (n = 8; 38.1%). Sixteen (76.2%) patients had fewer surgical interventions in the year following INO-3107 administration, with a median decrease of 3 interventions versus the preceding year. The RRP severity score, modified by Pransky, showed improvement from baseline to week 52. INO-3107 induced durable cellular responses against HPV-6 and HPV-11, with an increase in activated CD4 and CD8 T cells and CD8 cells with lytic potential.

Conclusion: The data suggest that INO-3107 administered by IM/EP is tolerable and immunogenic and provides clinical benefit to adults with RRP.

Level of evidence: 3 Laryngoscope, 133:3087-3093, 2023.

Keywords: DNA immunotherapy; HPV-6/HPV-11; INO-3107; electroporation; recurrent respiratory papillomatosis.

PubMed Disclaimer

Comment in

References

BIBLIOGRAPHY

    1. Ivancic R, Iqbal H, de Silva B, Pan Q, Matrka L. Current and future management of recurrent respiratory papillomatosis. Laryngoscope Investig Otolaryngol. 2018;3(1):22-34.
    1. Major T, Szarka K, Sziklai I, Gergely L, Czegledy J. The characteristics of human papillomavirus DNA in head and neck cancers and papillomas. J Clin Pathol. 2005;58(1):51-55.
    1. Derkay CS, Bluher AE. Update on recurrent respiratory papillomatosis. Otolaryngol Clin North Am. 2019;52(4):669-679.
    1. Dable C, Nicolli E. Manifestations of human papillomavirus in the head and neck. Med Clin North Am. 2021;105(5):849-858.
    1. Sievers C, Robbins Y, Bai K, et al. Comprehensive multiomic characterization of human papillomavirus-driven recurrent respiratory papillomatosis reveals distinct molecular subtypes. Commun Biol. 2021;4(1):1416.

Publication types

Supplementary concepts

Associated data

LinkOut - more resources