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- || PRGN-2012 / Precigen
Review, Journal: Update on HPV-associated head and neck cancers-highlights of the 2024 ASCO Annual Meeting (Pubmed Central) - Nov 18, 2024
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New P3 trial: Confirmatory Study of PRGN-2012 in Patients with RRP (clinicaltrials.gov) - Aug 5, 2024
P3, N=42, Recruiting, Sponsor: Precigen, Inc
- PRGN-2012 / Precigen
PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients. (E450b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3584;
P1/2
These data demonstrate the overall favorable safety profile and significant clinical benefit of PRGN-2012 in adult RRP patients. These findings support PRGN-2012 as a potential therapeutic option for this patient population where no FDA-approved therapeutics exist.
- | PRGN-2012 / Precigen
Biomarker, Journal, Tumor microenvironment: The tumor microenvironment state associates with response to HPV therapeutic vaccination in patients with respiratory papillomatosis. (Pubmed Central) - Oct 29, 2023
P1/2
PRGN-2012 is a gorilla adenovirus immune-therapeutic capable of enhancing HPV 6/11-specific T cell immunity...Conversely, nonresponders were characterized by greater HPV and CXCL8 gene expression, increased neutrophilic cell infiltration, and reduced T cell papilloma infiltration. These results suggest that papilloma HPV gene expression may regulate interferon signaling and chemokine expression profiles within the tumor microenvironment that cooperate to govern clinical response to therapeutic HPV vaccination in patients with respiratory papillomatosis.
- | PRGN-2012 / Precigen
Enrollment closed, Trial completion date: Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis (clinicaltrials.gov) - Oct 6, 2023
P1/2, N=38, Active, not recruiting, Sponsor: Precigen, Inc
These results suggest that papilloma HPV gene expression may regulate interferon signaling and chemokine expression profiles within the tumor microenvironment that cooperate to govern clinical response to therapeutic HPV vaccination in patients with respiratory papillomatosis. Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Jun 2026
- PRGN-2012 / Precigen
Significant clinical benefit and enhanced T-cell responses with repeated administration of PRGN-2012, a novel gorilla adenoviral vector based immunotherapy, in adult patients with severe Recurrent Respiratory Papillomatosis (Shed 2A) - Aug 29, 2023 - Abstract #ESGCT2023ESGCT_15;
P1/2
Based on these findings, PRGN?2012 has been granted FDA's Breakthrough Therapy Designation for the treatment of RRP. The Phase 2 portion of the study has completed enrollment and treatment at the RP2D (n = 23), and interim data will be presented.
- | PRGN-2012 / Precigen
Trial completion date, Trial primary completion date: Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis (clinicaltrials.gov) - Jan 9, 2023
P1/2, N=48, Recruiting, Sponsor: Precigen, Inc
The Phase 2 portion of the study has completed enrollment and treatment at the RP2D (n = 23), and interim data will be presented. Trial completion date: Oct 2023 --> Mar 2024 | Trial primary completion date: Oct 2022 --> Mar 2024
- | PRGN-2012 / Precigen
Phase classification, Enrollment change: Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis (clinicaltrials.gov) - Feb 25, 2022
P1/2, N=48, Recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Oct 2023 --> Mar 2024 | Trial primary completion date: Oct 2022 --> Mar 2024 Phase classification: P1 --> P1/2 | N=22 --> 48
- | PRGN-2012 / Precigen
Enrollment open: Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis (clinicaltrials.gov) - Mar 9, 2021
P1, N=22, Recruiting, Sponsor: National Cancer Institute (NCI)
Phase classification: P1 --> P1/2 | N=22 --> 48 Not yet recruiting --> Recruiting
- | PRGN-2012 / Precigen
New P1 trial: Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis (clinicaltrials.gov) - Jan 26, 2021
P1, N=22, Not yet recruiting, Sponsor: National Cancer Institute (NCI)