Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients

Author:

Lee Ian Y1ORCID,Hanft Simon2,Schulder Michael3,Judy Kevin D4,Wong Eric T5,Elder J. Bradley6,Evans Linton T7,Zuccarello Mario8,Wu Julian9,Aulakh Sonikpreet10,Agarwal Vijay11,Ramakrishna Rohan12,Gill Brian J13,Quiñones-Hinojosa Alfredo14,Brennan Cameron15,Zacharia Brad E16,Silva Correia Carlos Eduardo17,Diwanji Madhavi18,Pennock Gregory K18,Scott Charles18,Perez-Olle Raul18,Andrews David W18ORCID,Boockvar John A19

Affiliation:

1. Henry Ford Health System, Detroit, MI 48202, USA

2. Westchester Medical Center, Valhalla, NY 10595, USA

3. Northwell Health at North Shore University Hospital, Lake Success, NY 11030, USA

4. Thomas Jefferson University, Philadelphia, PA 19107, USA

5. Rhode Island Hospital & The Warren Alpert Medical School of Brown University, Providence, RI 02912, USA

6. Ohio State University, Columbus, OH 43210, USA

7. Dartmouth Hitchcock Medical Center, Lebanon, NH 03766, USA

8. University of Cincinnati Medical Center, Cincinnati, OH 45219, USA

9. Tufts Medical Center, Boston, MA 02111, USA

10. West Virginia University, Morgantown, WV 26506, USA

11. Montefiore Medical Center, Bronx, NY 10467, USA

12. Cornell University Weill Medical Center, New York, NY 10065, USA

13. Columbia University Medical Center, New York, NY 10019, USA

14. Mayo Clinic, Jacksonville, FL 32224, USA

15. Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

16. Penn State University, Hershey, PA 17036, USA

17. Jersey Shore University Medical Center, Neptune City, NJ 07753, USA

18. Imvax, Inc., Philadelphia, PA 19106, USA

19. Lenox Hill Hospital, New York, NY 10075, USA

Abstract

Standard-of-care first-line therapy for patients with newly diagnosed glioblastoma (ndGBM) is maximal safe surgical resection, then concurrent radiotherapy and temozolomide, followed by maintenance temozolomide. IGV-001, the first product of the Goldspire™ platform, is a first-in-class autologous immunotherapeutic product that combines personalized whole tumor–derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers, with the intent to induce a tumor-specific immune response in patients with ndGBM. Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety.

Funder

Imvax, Inc.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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