股价大涨近59%！FDA批准Precigen公司的一款治疗HPV相关疾病的基因疗法

Core Viewpoint - Precigen's Papzimeos (zopapogene imadenovec) has received FDA approval for the treatment of adult recurrent respiratory papillomatosis (RRP), marking it as the first approved therapy targeting the root cause of RRP [1][7][16] Group 1: FDA Approval and Market Impact - The FDA granted full approval to Papzimeos without the need for confirmatory clinical trials, following its rolling Biologics License Application (BLA) submission in December 2024 [1] - Following the announcement, Precigen's stock surged by 59% on August 15, reaching a market capitalization of $880 million [3] Group 2: Treatment Details and Efficacy - Papzimeos is a non-replicating adenoviral vector immunotherapy designed to induce an immune response against HPV types 6 and 11, administered through four subcutaneous injections over 12 weeks [7][12] - In a pivotal study, 51% of participants achieved complete response (CR), with an 86% reduction in the need for surgeries within 12 months post-treatment [8][13] - The therapy demonstrated good tolerability, with no treatment-related adverse events above grade 2, and the most common side effects being mild [15] Group 3: Clinical Study Insights - The pivotal study involved 35 patients, with a mean age of 49.3 years, and showed significant immune responses specific to HPV 6/11 [12][8] - Among the 18 patients who achieved complete response, 15 maintained this status at the 24-month evaluation [8] Group 4: Company Background and Future Directions - Precigen, originally founded in 1998 and rebranded in 2020, focuses on innovative therapies, including the AdenoVerse platform for complex diseases [16] - The company is also advancing other platforms like UltraCAR-T, aimed at addressing challenges in traditional CAR-T therapies [16] Group 5: Industry Context - In the domestic market, several companies are developing therapeutic HPV vaccines, particularly using mRNA technology, targeting HPV-related cervical intraepithelial lesions [17]