Precigen (PGEN) is a novel biotech company with a broad R&D pipeline focused on immuno-oncolgoy, autoimmune and infectious diseases, explains Jay Silverman, an analyst with The Medical Technology Stock Letter.
The company’s ULTRA-CAR-T technology has the advantages of non-viral multi-gene delivery, overnight manufacturing process, higher antigen-specific expansion and in vivo persistence, with an integrated kill switch.
The lead compounds under development are all in clinical trials with positive data recently and/or about to be presented in 2023 Recent data was presented at ASH (December) for PRGN-3006 UltraCAR-T® in acute myeloid leukemia (AML).
In late-stage, terminal patients, there was a 27% objective response rate with patients receiving one dose in an ongoing Phase 1b study. Dose expansion is underway at the Mayo Clinic in Rochester, Minnesota, with multi-center expansion and technology transfer and site activation activities underway at multiple new centers.
PRGN-2012 — Enrollment is complete in Phase 1 study of PRGN-2012 AdenoVerseTM Immunotherapy in recurrent respiratory papillomatosis (RRP); the data will be presented in January 2023 and it is expected to show at least a 40% response rate in these patients.
Recurrent respiratory papillomatosis (RRP) is a disease characterized by recurrent wart-like growths on the surface of the vocal cords or tissue around the vocal cords. A Phase 2 study has been initiated and is rapidly progressing.
Most important, based on the positing upcoming results and the fact that there is no other treatment for these patients other than repeated surgeries (tens or hundreds per patient), we believe the Company will be able to gain an accelerated FDA path for PRGN-2012.
PRGN-3005 — Enrollment is complete in the Phase I trial of PRGN-3005 UltraCAR-T in advanced ovarian cancer; enrollment complete at Dose Level 3 with lymphodepletion in the IV arm; early data from the initial very late-stage patients, objective responses have been observed. PRGN-3005 UltraCAR-T is manufactured using a decentralized, overnight manufacturing process and administered patients the next day.
PRGN-2009 — Enrollment complete in combination arm of Phase 1 study of PRGN-2009 AdenoVerse Immunotherapy in human papillomavirus (HPV)- associated cancers. PRGN-2009 leverages Precigen’s UltraVector® and AdenoVerse™ platforms to optimize HPV antigen design and delivery using a gorilla adenovector with a large payload capacity and the ability for repeat administration.
We believe encouraging data on any of the four programs above will lead to at least one large corporate partnership this year. Since it owns its technology outright, we also believe Precigen is a very attractive takeover candidate, in particular at the current, depressed market valuation.
2023 will be a transformative year for the company with further clinical and corporate progress in the broad R&D pipeline. Precigen is a "buy" under $8 with a target price of $18.