Recommended as first-line treatment per the RRP Foundation consensus statement.1,2
Intended for US healthcare professionals only.
CLEAR the way for a different type of RRP treatment
The first and only FDA-approved therapy to treat recurrent respiratory papillomatosis (RRP) in adults1,3
The path forward is CLEAR. Get the details behind PAPZIMEOS and see how it could help your patients with RRP.
Mechanism of action
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response against papilloma cells infected with HPV 6 or HPV 11.1
Watch now to learn the science behind PAPZIMEOS.
PAPZIMEOS was shown to induce higher HPV 6- and HPV 11-specific T-cell responses in patients with RRP who demonstrated a reduction in or elimination of the requirement for surgical debulking during the 12 months post-treatment completion.1
Overview of the pivotal phase 1/2 clinical trial study design
PAPZIMEOS was studied in an open-label, single-arm, phase 1/2 trial in adult patients with RRP.1,3
Key eligibility criteria3:
- Adults aged 18 years or older with a clinical diagnosis of RRP
- Required ≥3 surgical interventions in the 12 months before treatment
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
PU=particle units; SQ=subcutaneous.
In the phase 1 portion of the study, 2 dose levels were tested: 1 x 1011 and 5 x 1011 PU. A total of 38 patients were enrolled in the trial. The efficacy population includes 35 of the 38 patients who were treated at a dose of 5 x 1011 PU per injection.3
All patients underwent a surgical debulking procedure before the first administration of PAPZIMEOS.3
If patients had visible regrowth of papillomas during the treatment interval, a surgical intervention could be performed prior to the third and fourth dose to maintain minimal residual disease.3
Clinical endpoints
Not actual size.
Primary endpoint
- Complete response (CR) rate: Percent of patients with no surgical interventions during the 12 months after treatment3
Key secondary endpoints
- Partial response (PR) rate: Percent of patients with at least a 50% decrease in the number of interventions in the
12 months post treatment compared to the 12 months pre treatment3 - Objective response rate (ORR): Percent of patients with a complete or partial response3
- Safety evaluation3
Exploratory endpoint
- T-cell response4
Overview of the pivotal phase 1/2 clinical trial study results
RESPONSE TO PAPZIMEOS TREATMENT
Primary endpoint: Complete response
51% COMPLETE RESPONSE RATE at 1 year
(n=18/35) of patients treated with PAPZIMEOS required no surgical intervention for 1 year post treatment
(95% CI: 34%-69%).1
Durability of complete response
15/18
15 out of 18 complete responders evaluated at 2 years demonstrated continued complete response.1
Exploratory analysis:
HPV 6- and HPV 11-specific T-cell responses1,4
At treatment completion, HPV 6- and HPV 11-specific T-cell responses were higher in patients who had a clinical response to PAPZIMEOS treatment.1§
This difference persisted at 12 weeks post treatment, with mean fold change of 61.5 in responders versus 11.5 in nonresponders.1
CI=confidence interval.
Clinical response to treatment refers to the elimination of surgery (CR) or a 50% reduction in surgical procedures (PR) in the 12 months following treatment completion compared to the 12 months prior to treatment initiation.1,4
Complete responses are ongoing, with most remaining durable at a median follow-up of 3 years (n=15/18).5
Complete responders are in a 5-year long-term follow-up, with a majority maintaining a complete response over a 36-month median follow-up period (range, 27-37 months). No new safety events were observed during this long-term follow-up.4,5||
Based on the data cutoff of September 19, 2025.
Summary of adverse reactions (ARs)
ARs occurring in ≥5% of patients treated with PAPZIMEOS (N=38)1
| Preferred Term | Grade 1-2¶ n (%) |
|---|---|
| Injection site reaction | 37 (97) |
| Fatigue | 28 (74) |
| Chills | 25 (66) |
| Pyrexia | 24 (63) |
| Myalgia | 11 (29) |
| Nausea | 10 (26) |
| Headache | 4 (11) |
| Tachycardia | 3 (8) |
| Diarrhea | 2 (5) |
| Vomiting | 2 (5) |
| Hyperhidrosis | 2 (5) |
Graded per NCI CTCAE v5.0.1
NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
Other clinically significant ARs occurring in <5% of patients included vision blurred (3%), injection site bruising (3%), dizziness (3%), dyspnea (3%), and pruritus (3%).1
There were no Grade >2 ARs.1
No treatment discontinuations; all patients received 4 doses of PAPZIMEOS.1
PAPZIMEOS dosing & administration
PAPZIMEOS is for subcutaneous injection provided as a suspension in a
single-dose vial.1
The recommended dose of PAPZIMEOS is 5 x 1011 PU per injection administered subcutaneously 4 times over a 12-week interval.1
Prior to the initial administration of PAPZIMEOS, perform a surgical debulking of visible papilloma to establish minimal residual disease.1
The second administration should occur no less than 11 days after the initial administration.1
To maintain minimal residual disease during treatment with PAPZIMEOS, remove visible papilloma, if present, prior to the third and fourth administration of PAPZIMEOS.1
- PAPZIMEOS carton must be stored in an appropriate freezer at ≤ -60°C [≤ -76°F] until ready to thaw and administer.1
- PAPZIMEOS MUST BE RAPIDLY thawed before use and prepared for immediate administration.1
- Once thawed, DO NOT place the PAPZIMEOS vial in a refrigerator, freezer, or on dry ice. Protect PAPZIMEOS from light. DO NOT shake the vial.1
- DO NOT hold PAPZIMEOS at room temperature for more than 60 minutes after thawing.1
Please see full Prescribing Information on DOSAGE AND ADMINISTRATION.
Support & resources
Learn about the Papzimeos SUPPORT program and download resources to help both your patients and your practice.
Get startedINDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
To report SUSPECTED ADVERSE REACTIONS, contact Precigen, Inc. at 1‑855‑PGE‑NRRP (1‑855‑743‑6777) 1‑855‑PGE‑NRRP (1‑855‑743‑6777) or medinfo@precigen.com or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
INDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
To report SUSPECTED ADVERSE REACTIONS, contact Precigen, Inc. at 1‑855‑PGE‑NRRP (1‑855‑743‑6777) 1‑855‑PGE‑NRRP (1‑855‑743‑6777) or medinfo@precigen.com or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
INDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
To report SUSPECTED ADVERSE REACTIONS, contact Precigen, Inc. at 1‑855‑PGE‑NRRP (1‑855‑743‑6777) 1‑855‑PGE‑NRRP (1‑855‑743‑6777) or medinfo@precigen.com or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
References: 1. PAPZIMEOS. Package insert. Precigen, Inc; 2025. 2. Best SR, Friedman AD, Rosen CA, et al. Recurrent Respiratory Papillomatosis Foundation position statement on the management of adults with RRP. Laryngoscope. Published online January 16, 2026. doi:10.1002/lary.70379 3. Norberg SM, Valdez J, Napier S, et al. PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial. Lancet Respir Med. 2025;13(4):318-326. doi:10.1016/S2213-2600(24)00368-0 4. Data on file. Precigen, Inc. 5. Norberg S, Giridhar PV, Semnani R, Bonifacio G, Lankford A, Allen C. Zopapogene imadenovec-drba, a novel adenoviral vector-based immunotherapy, induces complete and durable responses in adults with recurrent respiratory papillomatosis (RRP). Presented at: AAO-HNSF 2025 Annual Meeting & OTO Expo; October 11-14, 2025; Indianapolis, IN.