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Recurrent Respiratory Papillomatosis

Four PRGN-2012 administrations (on days 1, 15, 43, and 85) via subcutaneous injection.

In the Phase 1, 3+3 dose escalation clinical trial evaluating PRGN-2012 at two dose levels (1x10\^11 and 5x10\^11 particle units (PU)) administered as adjuvant therapy prior to standard-of-care debulking surgery.

In the Phase 2 segment, PRGN-2012 is evaluated at the RP2D.

PRGN-2012

Amy Lankford, PhD

This is a Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.

This is a nonrandomized, Phase 1/2 safety and tolerability study. The safety and tolerability of PRGN-2012 will be assessed following two different dose levels during the Phase 1 dose escalation trial. In the Phase 2 portion of the study, treatment with PRGN-2012 at the recommended Phase 2 dose (RP2D) will be used to determine safety and efficacy of PRGN-2012.

Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

A complete response is defined as no requirement for surgical intervention in the 12 months after treatment

The incidence of dose limiting toxicities in Phase 1 will be reported per dose level. The dose level at which less than or equal to 1 out of 6 patients experience DLT will be identified as a RP2D.

Systemic toxicity will be assessed through the capture of Treatment Emergent Adverse Events ( TEAEs) at Phase 1 and Phase 2 patients. The severity of the TEAEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 scale.

Change in HPV-specific T cells post-treatment compared to baseline

Absolute and percentage change from baseline in Derkay score over time following initiation of PRGN-2012 treatment

Absolute and percentage change from baseline in VHI-10 score over time following initiation of PRGN-2012 treatment

Time to recurrence of papillomatous disease after completion of treatment will be recorded. Time from completion of treatment to first surgery will be assessed.

The number of surgeries in the 12 months post-treatment will be compared to the number of surgeries in the 12 months pre-treatment to identify subjects that have a reduction in the number of surgeries.

The number of surgeries in the 12 months post-treatment will be compared to the number of surgeries in the 12 months pre-treatment.

Determine the percentage of subjects with at least a 50% decrease in the number of surgeries during the 12 month period following completion of PRGN-2012 treatment as compared to the number of surgeries during the 12 months prior to PRGN-2012 treatment initiation.

The fraction of participants with a pulmonary RRP partial response will be reported in all treated pulmonary participants.

The fraction of participants with a pulmonary RRP complete response will be reported in all treated pulmonary participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis	NCT04724980	Recurrent Respi... Papillomavirus ... Papillomavirida...	PRGN-2012	18 Years -	Precigen, Inc
Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis	NCT04724980	Recurrent Respi... Papillomavirus ... Papillomavirida...	PRGN-2012	18 Years -	Precigen, Inc

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