The US FDA has cleared the IND application to initiate a P-II study evaluating PRGN-2009 (off-the-shelf AdenoVerse immunotherapy) + pembrolizumab vs pembrolizumab monotx. in a ratio (1:1) in ~46 patients
The primary objective of the P-II study is to evaluate the ORR following treatment with PRGN-2009 + pembrolizumab over pembrolizumab monotx. while the secondary objectives incl. the evaluation of safety, tolerability, PFS, OS, BOR, DCR, time to response & DoR
The interim P-I results showed a favorable safety profile of PRGN-2009 as monotx. & combination with a checkpoint inhibitor, ORR (30%) with no DLTs along with encouraging clinical activity in patients with heavily pre-treated HPV-associated cancers
Ref: PRNewswire | Image: Precigen
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