Precigen Announces Study Data For PRGN-2012 For Recurrent Respiratory Papillomatosis Patients; Phase 1/2 Pivotal Study Met Primary And Efficacy Endpoints

–   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 –