Precigen announces groundbreaking pivotal study data for prgn-2012 in patients with recurrent respiratory papillomatosis in which more than half of patients achieved complete response

–   phase 1/2 pivotal study met the primary safety and efficacy endpoints – –   51% (18 out of 35) of patients achieved complete response, requiring no surgeries after treatment with prgn-2012; complete responses have been durable beyond 12 months with median duration of follow up of 20 months as of data cutoff – –   86% of patients (30 out of 35) had a decrease in surgical interventions in the year after prgn-2012 treatment compared to the year prior to treatment; rrp surgeries reduced from a median of 4 pre-treatment to 0 post-treatment – –   prgn-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than grade 2 – –   prgn-2012 treatment induced hpv 6/11-specific t cell responses in rrp patients with a significantly greater expansion of peripheral hpv-specific t cells in responders compared with non-responders – –   prgn-2012 significantly (p < 0.0001) improved derkay and quality of life scores in complete responders – –   rrp is a rare, devastating hpv-mediated chronic disease characterized by growth of benign tumors for which the current standard-of-care is repeated surgeries ; if approved, prgn-2012 has the potential to be the first fda-approved therapeutic for the treatment of rrp – –   clinical data associated with favorable safety, strong efficacy, ease of administration, and immunological responses, position prgn-2012 to potentially be the preferred treatment-of-choice for rrp – –   prgn-2012 rolling bla submission, under an accelerated approval pathway, is anticipated in the second half of 2024 – –   precigen to host webcast event today at 6:00 pm ct / 7:00 pm et – germantown, md. , june 3, 2024 /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 released positive phase 1/2 pivotal study results for the investigational prgn-2012 off-the-shelf (ots) adenoverse ® gene therapy in patients with recurrent respiratory papillomatosis (rrp).
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