Precigen (PGEN) is focused on completing the PRGN-2012 Phase II trial in the second quarter of 2024 and, given the FDA’s guidance in August 2023 that the ongoing Phase I/II trial of PRGN-2012 will serve as the pivotal study to support an accelerated approval request, working to expedite the submission of a BLA as quickly as possible, explains John McCamant, editor of The Medical Technology Stock Letter.
The company has recently published new data for both of their core platforms, AdenoVerse and UltraCAR-T, including presentations at the ESGCT 30th Annual Congress for PRGN-3007 UltraCAR-T and PRGN-2012 AdenoVerse immunotherapy, and publication of a manuscript in Science Translational Medicine that includes full Phase I clinical data from PRGN-2012. In our view, PGEN has done a good job prioritizing their financial resources by focusing on 2012 and has $79 million in cash which will last until 2025.
PRGN-2012 is an investigational, off-the-shelf AdenoVerse immunotherapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of recurrent respiratory papillomatosis (RRP). The FDA has granted Breakthrough Therapy Designation and Orphan Drug Designation for PRGN-2012 for the treatment of RRP.
The Company announced in August that the FDA has agreed that the ongoing Phase 1/2 (NCT04724980) single-arm study will serve as pivotal for the purpose of filing an accelerated approval request for licensure. Based on this FDA guidance, the Company plans to initiate a confirmatory study prior to submission of the biologics license application (BLA).
Enrollment and dosing in the Phase II portion of the study (N=23) is complete, bringing the total number of enrolled patients to 35 at Dose Level 2. Patient follow up is currently ongoing and the Phase II trial is expected to be complete by the second quarter of 2024.
Recommended Action: Buy PGEN.