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

–  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.
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