Pioneering a novel investigational therapeutic for RRP patients

PRGN-2012 targets HPV6/11 infected cells
Breakthrough Therapy Designation granted from FDA
Orphan Drug Designation granted in US and EU


Novel gene therapy platform to train and amplify the immune system in vivo

Large payload capacity

Low seroprevalence in humans

Ability for repeat administration

Durable antigen-specific immune response

Highly productive manufacturing process

AdenoVerse Pipeline

ProductPlatformIndicationDiscoveryPreclinicalPhase 1Phase 2Phase 3
PRGN-2012AdenoVerseRecurrent Respiratory Papillomatosis
AdenoVerseOropharyngeal Squamous Cell Carcinoma
Head & Neck Cancer
AdenoVerseRecurrent/Metastatic Cervical Cancer

Recurrent Respiratory Papillomatosis – RRP

A rare disease with no approved therapeutic


Recurring HPV-mediated tumors on the larynx can cause severe voice disturbance, airway compromise, fatal pulmonary lesions and invasive cancers

HPV 6 and HPV 11 infections are the drivers of the disease

Affects both children and adults

Some patients require hundreds of lifetime surgeries

PRGN-2012 Phase 1 study data demonstrated overall safety and clinical benefit

PRGN-2012 Phase 1 Results

PRGN-2012 demonstrated a significant reduction in surgeries in adult patients with 3 or more RRP surgeries in the prior year*:

50% of patients in durable complete response (CR)

83% of patients with reduction in need for RRP surgeries

Safety profile: PRGN-2012 was well tolerated, with no DLTs and no TRAEs greater than Grade 2

Phase 2 pivotal data to be presented at ASCO on June 3, 2024

*Norberg et al., Sci. Transl. Med. 15, DOI: 10.1126/scitranslmed.adj0740
Published October 25, 2023

Proposed Confirmatory Study

Study Population
Adult patients requiring a minimum of 3 surgeries in the 12 months prior to treatment

PRGN-2012 Dosing
Four subcutaneous PRGN-2012 administrations

Investigational Sites
Plans to activate 8-10 clinical sites

Lead Site
National Institutes of Health, Bethesda, MD