Precigen Gets FDA Clearance to Start Phase 2 Study of AdenoVerse Immunotherapy

By Chris Wack

Precigen said Wednesday the U.S. Food and Drug Administration has cleared the Investigational New Drug application to begin a Phase 2 study of its first-in-class PRGN-2009 AdenoVerse immunotherapy in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer.

The biopharmaceutical said the Phase 2 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 46 patients who previously have been treated with pembrolizumab for recurrent or metastatic disease.

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.

The primary objective of the Phase 2 study is to assess the objective response rate following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab monotherapy. Secondary objectives include the evaluation of safety and tolerability, progression-free survival, overall survival, best overall responses, Disease Control Rate, time to response and duration of response.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

May 31, 2023 08:35 ET (12:35 GMT)

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