|Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study of PRGN-2009 Off-the-Shelf AdenoVerse Immunotherapy in Combination with Pembrolizumab to Treat Patients with Recurrent or Metastatic Cervical Cancer|
|By: PR Newswire Association LLC. - 31 May 2023||Back to overview list
– HPV is responsible for more than 90 percent of cervical cancer cases globally with approximately 300,000 women living with cervical cancer in the US –
– Current response rates to second line treatments in recurrent or metastatic cervical cancer are very low and associated with a high rate of toxicity –
– PRGN-2009 is designed to generate de novo T-cell immune response against HPV 16/18-positive solid tumors cells and is differentiated from other platforms due to the ability of gorilla adenovectors to enable repeat administrations –
– PRGN-2009 Phase 1 data to be presented at the 2023 ASCO annual meeting on June 3 (Abstract # 2628); PRGN-2009 in combination with a checkpoint inhibitor demonstrated a favorable safety profile and resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers, including those who have previously failed checkpoint inhibitors –
– Phase 2 study of PRGN-2009 is in combination with pembrolizumab in the second line setting in patients with recurrent or metastatic cervical cancer previously treated with pembrolizumab for recurrent or metastatic disease –
– CMC path in place to support delivery of product for Phase 2 study as well as future framework to support potential pivotal trials –
GERMANTOWN, Md., May 31, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase 2 study of the first-in-class PRGN-2009 Off-the-Shelf (OTS) AdenoVerse™ immunotherapy in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer. The Phase 2 randomized, open-label, two-arm, multicenter study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab versus pembrolizumab monotherapy in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. The study will enroll approximately 46 patients who previously have been treated with pembrolizumab for recurrent or metastatic disease.
In the Phase 1 study, PRGN-2009 was evaluated as a monotherapy (N=6) and in combination with a checkpoint inhibitor (N=11) in patients with recurrent or metastatic human papillomavirus (HPV)-associated cancers. Interim Phase 1 data showed a favorable safety profile of repeated PRGN-2009 administrations in both the monotherapy and the combination arms with no dose limiting toxicities (DLTs). Interim Phase 1 data showed encouraging clinical activity with objective responses when combined with a checkpoint inhibitor in heavily pre-treated recurrent/metastatic cancer patients who had previously failed checkpoint inhibitor treatment. Full Phase 1 data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2023 from 8:00 to 11:00 AM CT (Abstract # 2628).
"Cervical cancer is a devastating disease for which there remains a significant unmet need for new and improved treatment options in the recurrent or metastatic setting," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are encouraged by the 30% ORR in the Phase 1 study which demonstrated a favorable safety profile with no dose-limiting toxicities, strong antigen-specific immune response and lack of significant neutralizing antibody response upon repeat administrations in combination with a checkpoint inhibitor. Based on these Phase 1 safety and efficacy data, the FDA has allowed us to treat patients as early as the second line in the recurrent or metastatic setting in this Phase 2 cervical cancer study. Additionally, we are pleased that in collaboration with FDA, we have agreed upon a CMC path to support the delivery of product for the Phase 2 study as well as a future framework to support potential pivotal trials."
Patients in the Phase 2 study will be randomized 1:1 to the combination of PRGN-2009 and pembrolizumab (cohort 1) or pembrolizumab monotherapy (cohort 2). Patients randomized to the PRGN-2009 plus pembrolizumab cohort will receive PRGN-2009 via subcutaneous (SC) injection (5 x 1011 PU every 3 weeks for three administrations followed by administration each 6 weeks thereafter). Patients in the PRGN-2009 plus pembrolizumab cohort and pembrolizumab monotherapy cohort will receive pembrolizumab via intravenous (IV) infusion (400 mg every 6 weeks). Patients randomized to the pembrolizumab monotherapy cohort will be offered the option to crossover to the PRGN-2009 plus pembrolizumab cohort if certain conditions are met.
The primary objective of the Phase 2 study is to assess the objective response rate (ORR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab monotherapy. Secondary objectives include the evaluation of safety and tolerability, progression-free survival (PFS), overall survival (OS), best overall responses (BOR), Disease Control Rate (DCR), time to response and duration of response.
Precigen: Advancing Medicine with Precision™
About Cervical Cancer1,2
AdenoVerse™ Immunotherapy Clinical Program
Cautionary Statement Regarding Forward-Looking Statements
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SOURCE Precigen, Inc.
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