On March 27, 2023 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported dosing of the first patient in the company’s randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM) (Press release, Imvax, MAR 27, 2023, View Source [SID1234629380]).
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"Progression into this Phase 2b clinical study is a significant milestone for both Imvax and the many patients and families facing a life-altering GBM diagnosis," said John P. Furey, Chief Executive Officer of Imvax. "For too long, there have been few advancements in the treatment of GBM; with the initiation of this trial, we take an important step towards our mission to deliver a personalized immunotherapy that provides meaningful clinical benefit to these patients in need."
The trial is a randomized, multicenter, double-blind, placebo-controlled Phase 2b study (NCT04485949) designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial is expected to enroll up to 93 participants in a 2:1 randomization across approximately 25 sites in the United States. After surgical resection, participants in the IGV-001 arm will be implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers will contain an inactive solution only. In both arms, the biodiffusion chambers will be explanted approximately 48 hours later, and after six weeks all patients will be treated with standard of care (adjuvant radiotherapy and temozolomide followed by maintenance temozolomide).
The primary endpoint of the trial is progression-free survival (PFS) and key secondary endpoints include overall survival (OS) and safety.
"The Imvax trial is a truly personalized immunotherapy approach to treating newly diagnosed GBM patients," said John A. Boockvar, M.D., Vice-Chair, Department of Neurosurgery, Lenox Hill Hospital, Professor of Neurosurgery and Otolaryngology, Zucker School of Medicine at Hofstra/Northwell and the lead investigator of the Phase 2b trial. "With this treatment, signals from the patient’s glioblastoma are released into the body as we seek to harness the patient’s own immune system to fight the brain tumor. It is an exciting and novel approach that is both scientifically sound and has encouraging Phase 1 safety data in 45 patients."
About IGV-001
IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b ndGBM study also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC.