– IGV-001 can induce stress on glioblastoma cells within the product, resulting in immunogenic cell death and consequent broad anti-tumor immunity –

– IGV-001 is currently being evaluated in a multicenter Phase 2b clinical study as a treatment, in combination with standard of care, for newly diagnosed glioblastoma –

Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, today announced the publication of preclinical research with IGV-001 in Journal for ImmunoTherapy of Cancer, the official journal of the Society for Immunotherapy of Cancer (SITC). The article — “A biologic-device combination product delivering tumor-derived antigens elicits immunogenic cell death-associated immune responses against glioblastoma” — is available online.

The publication presents preclinical data demonstrating that IGV-001, a biologic-device combination product candidate developed with autologous tumor cells using Imvax’s proprietary Goldspire™ platform, can induce oxidative and endoplasmic reticulum stress on glioblastoma (GBM) cells in IGV-001, resulting in immunogenic cell death, the release of a tumor antigen payload, and consequent anti-tumor immunity. This study provides further data concerning the mechanism of action of IGV-001 and supports the Company’s ongoing Phase 2b clinical trial of IGV-001 in newly diagnosed GBM (NCT04485949).

“The results of our prior Phase 1b trial in newly diagnosed GBM patients established the clinical potential of IGV-001,” said Mark A. Exley, Chief Scientific Officer of Imvax. “This newly published preclinical data confirms that our Goldspire platform induces immunogenic tumor cell death in IGV-001, which can lead to a sustained anti-tumor immune response.”

“The ability of cancer therapeutics such as IGV-001 to elicit cancer cell death along with the activation of a tumor-targeting immune response offers a considerable opportunity for the development of novel immunotherapeutic regimens for diseases, including GBM, that are poorly sensitive to conventional immunotherapy,” said Lorenzo Galluzzi, Ph.D., Assistant Professor of Cell Biology in Radiation Oncology, Weill Cornell Medicine, New York, NY.

Imvax’s Goldspire immuno-oncology platform for solid tumors involves a unique approach to inducing a broad and durable immune response against tumors. This platform combines patient-derived tumor cells and an antisense oligodeoxynucleotide (IMV-001) in proprietary biodiffusion chambers that are irradiated with a low dose of radiation before being returned to the hospital for implantation in the patient.

Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b study in newly diagnosed GBM (ndGBM) patients also yielded several efficacy signals, including significant improvements in progression-free survival, overall survival, radiographic evidence of tumor response and multiple biomarker changes that supported the presence of an immune response (Andrews, D.W., 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. In March 2023, Imvax initiated a Phase 2b clinical trial of IGV-001 in ndGBM patients (NCT04485949).

About Imvax, Inc.

Imvax is a clinical-stage biotechnology company with a unique platform technology, Goldspire™, focused on delivering personalized, whole tumor-derived immunotherapies across a range of solid tumors. Imvax’s most advanced program, IGV-001, is currently being evaluated in a Phase 2b clinical trial in newly diagnosed glioblastoma patients. Imvax’s portfolio also includes several other programs designed to stimulate a patient’s immune system against the entire antigen signature of their tumor. Imvax is headquartered in Philadelphia, PA. For additional information, please visit www.imvax.com.

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