– IGV-001 preclinical studies show Goldspire™ platform induces tumor cell death and release of an immunogenic payload correlated with enriched immune activity –

– Lymph nodes exposed to IGV-001 enriched in activated and matured immune cell subsets –

– IGV-001 currently being evaluated as a treatment for newly diagnosed glioblastoma in a multicenter Phase 2b clinical study –

Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, today announced a poster presentation providing additional mechanistic insights into its Goldspire™ platform based on preclinical studies of its lead product candidate, IGV-001, for the treatment of glioblastoma (GBM). These data are being presented at the American Association for Cancer Research Annual Meeting in Orlando, FL, running from April 14-19, 2023.

“These new data provide us with deeper insights into the unique mechanism of our personalized immunotherapy platform, Goldspire, that combines whole-tumor derived cells with an antisense nucleotide in proprietary implanted chambers,” said Mark A. Exley, Ph.D., Chief Scientific Officer. “The Goldspire platform is designed to induce a durable, broad-spectrum immune response against tumors, and additional studies like this one are key to furthering our understanding of both IGV-001 and our platform.”

The data published in the AACR poster presentation examined the effect on tumor cells of the Goldspire process, the release of subcellular immunogenic particles, their transit across the diffusible membrane of the implanted chambers and related immunological changes. IGV-001 was found to impose oxidative and endoplasmic reticulum stress onto GBM cells. Particle analysis confirmed that a human variant of IGV-001 prepared with human GBM cells produced particles that can efficiently diffuse through the membrane of the implanted chambers. Finally, the results indicated that lymph nodes through which IGV-001 drains are enriched in mature antigen-presenting cells and lymphoid effector cells.

The poster can be found on the Imvax website and the details for the presentation are below:

Title: ROS-dependent activation of immunogenic glioblastoma cell death & release of immunogenic particles by an autologous cell-based immunotherapeutic platform

Number: 1812

Timing: Monday, April 17, 2023, 9:00 AM - 12:30 PM

Presenter: Jenny Zilberberg, Ph.D.

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 study in newly diagnosed GBM (ndGBM) patients 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. 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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