On November 11, 2024 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole-tumor derived immunotherapies, reported an oral presentation and two poster presentations at the 2024 Society for NeuroOncology (SNO) 29th Annual Meeting in Houston, Texas, from November 21-24, 2024 (Press release, Imvax, NOV 11, 2024, View Source [SID1234648092]). Separately, the Company will also host a symposium focused on the development of IGV-001 for the treatment of newly diagnosed glioblastoma.
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Imvax will present blinded safety data from the Company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). The Phase 2b study to assess the safety and efficacy of IGV-001 in patients with ndGBM (NCT04485949) has completed enrollment and top-line results are expected to be presented in mid-2025. Imvax will also present follow-on data from its Phase 1b study of IGV-001 in patients with ndGBM, as well as preclinical data of IGV-001 in combination with checkpoint inhibitors.
The details of the oral presentation and two poster presentations are below:
Title: Early safety data from a randomized, multicenter, double-blind, phase 2b study of IGV-001, an autologous cell immunotherapy, versus placebo, in newly diagnosed glioblastoma (ndGBM)
Number: CTIM-14
Timing: November 22, 7:25 p.m. – 7:35 p.m. CST
Presenter: Brad Elder, M.D.
Title: Long-term survivors from a Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma
Number: CTIM-11
Timing: November 21-22, 7:30 p.m. – 9:30 p.m. CST
Presenter: Raul-Perez Olle, M.D., Ph.D.
Title: IGV-001: A biologic-device combination product elicits potent anti-GBM responses as a monotherapy and in combination with check point inhibition
Number: IMMU-30
Timing: November 21-22, 7:30 p.m. – 9:30 p.m. CST
Presenters: Jenny Zilberberg, Ph.D. & Mark A. Exley, Ph.D.
On Friday, November 22, 2024, from 12:45 p.m. – 1:45 p.m. CST, Raul Perez-Olle, M.D., Ph.D., SVP, Head of Clinical Development and Medical Affairs at Imvax, Brad Zacharia, M.D., M.S., FAANS, Associate Professor of Neurosurgery and Otolaryngology at Penn State Health, and Brad Elder, M.D., Director, Neurosurgical Oncology, and Associate Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center, will host a symposium, entitled "Development of IGV-001 for the treatment of newly diagnosed glioblastoma," focused on Imvax’s proprietary Goldspire platform and the development of IGV-001 for the treatment of ndGBM. Register for the session here.
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.