Precigen highlights results from UltraCAR-T trials

By The Science Advisory Board staff writers

November 4, 2021 -- Precigen has released initial results from phase I studies of drugs included in its UltraCAR-T and AdenoVerse platforms.

During a virtual event, trial investigators reported on the clinical progress of three therapies included in the company's UltraCAR-T platform: PRGN-3005, PRGN-3006, and PRGN-3007. In addition, presentations were given relating to two therapies in its AdenoVerse immunotherapy platform: PRGN-2009 off-the-shelf (OTS) AdenoVerse Immunotherapy and PRGN-2012 OTS AdenoVerse Immunotherapy.

The following data was presented:

  • In the lymphodepletion cohort of an ongoing trial, a 50% (3 out of 6 patients) objective response rate (ORR) was observed in relapsed or refractory acute myeloid leukemia patients treated with PRGN-3006 at the two lowest dose levels (comprising a single administration of four to 28 million UltraCAR-T cells).
  • A 40% ORR (2 out of 5) and 60% disease control rate (3 out of 5) was observed in recurrent or metastatic human papilloma virus-associated cancer patients treated in the PRGN-2009 combination arm of an ongoing trial.

  • Preliminary PRGN-2012 phase I data shows encouraging clinical activity, including ongoing reduction of the need for surgical intervention at the most recent follow-up, up to 12 weeks after PRGN-2012 treatment.
  • PRGN-3005 and PRGN-3006 UltraCAR-T demonstrated favorable safety profiles with no dose-limiting toxicities or neurotoxicity, dose-dependent in vivo expansion, and durable persistence.
  • PRGN-2009 and PRGN-2012 AdenoVerse immunotherapies demonstrated favorable safety profiles with no dose-limiting toxicities, strong antigen-specific immune response, and a lack of a significant neutralizing antibody response upon repeat administrations.

UltraCAR-T therapies are composed of genetically modified autologous T cells that simultaneously express an antigen-specific CAR, membrane-bound interleukin-15 (IL-15), and a kill switch.

Including the gene-encoding, membrane-bound IL-15 slows the aging of UltraCAR-T cells and leads to increased expansion of cells in vivo. The kill switch allows for rapid destruction of UltraCAR-T cells in the event of adverse events, which increases the safety profile of the therapy, the company said.

Precigen received clearance from the U.S. Food and Drug Administration last year for manufacturing UltraCAR-T therapies.

Precigen doses first patients with UltraCAR-T cells
Precigen said that the first patients in two phase I clinical trials have been treated with UltraCAR-T cells manufactured by its UltraPorator system.
Precigen nabs FDA nod for manufacturing UltraCAR-T therapies
Precigen has been granted clearance by the U.S. Food and Drug Administration (FDA) for its UltraPorator system. The system also had a successful technology...
Merck increases stake in Precigen
Merck is increasing its stake in Precigen from approximately 11.6% to 14.8% of outstanding shares through a convertible note with an outstanding principal...
Precigen begins clinical trial for HPV-positive tumors
Precigen has dosed the first patients with Prgn-2009, an off-the-shelf investigational immunotherapy candidate, in a phase I/II clinical trial for the...
Precigen touts heart failure multigenic therapy results
Precigen is highlighting clinical results from a phase I trial conducted by its subsidiary Precigen Triple-Gene that show that its multigenic investigational...

Copyright © 2021

Glasgow International Health Festival
August 24-27
Glasgow, Glasgow City United Kingdom
Pharma Competitive Intelligence Conference and Exhibition
September 21-22
Newark, New Jersey United States
BioProcess International (BPI) Conference
September 27-30
Boston, Massachusetts United States
Laboratory Products Association Annual Meeting
October 1-4
Scottsdale, Arizona United States
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter