Recommended as first-line treatment per the
RRP Foundation position statement.1,2

PAPZIMEOS safety profile

Summary of adverse reactions (ARs)

ARs occurring in ≥5% of patients treated with PAPZIMEOS (N=38)1,3

Preferred term Grade 1* n (%) Grade 2* n (%)
Injection site reaction 37 (97) 0
Fatigue 28 (74) 2 (5)
Chills 25 (66) 0
Pyrexia 24 (63) 0
Myalgia 9 (24) 2 (5)
Nausea 10 (26) 0
Headache 4 (11) 0
Tachycardia 3 (8) 0
Diarrhea 2 (5) 0
Vomiting 2 (5) 0
Hyperhidrosis 2 (5) 0

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

PAPZIMEOS has been shown to be well tolerated. There were no Grade >2 ARs in the pivotal trial.1,4

In the clinical trial, there were no treatment discontinuations due to ARs. All patients received 4 doses of PAPZIMEOS. There were no dose-limiting toxicities or treatment-related serious ARs.1,4

No new ARs were observed during long-term follow-up.5†

Median duration of 36 months (range, 27-37 months).5

PAPZIMEOS dosing

PAPZIMEOS is for subcutaneous injection provided as a suspension in a single-dose 1-mL vial.1

Discover dosing

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.

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.

  1. References:
  2. PAPZIMEOS. Package insert. Precigen, Inc; 2025.
  3. 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
  4. Data on file. Precigen, Inc.
  5. 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
  6. 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.