Imvax Announces Additional Data from Phase 2b Clinical Trial of IGV-001 in Newly Diagnosed GBM and Provides Update on Planned Clinical Development

– Top-line, prespecified analysis in patients with unmethylated MGMT newly diagnosed glioblastoma (ndGBM) suggests clinically meaningful improvement in overall survival, preservation of neurological function, and benefit to patient-reported outcomes –

– Data to be presented at 2026 Annual Meeting of the Society for Neuro-Oncology (SNO) –

– FDA alignment secured on key elements of proposed Phase 3 trial design in uMGMT ndGBM patients –

PHILADELPHIA--(BUSINESS WIRE)--Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, today announced that an abstract reporting results from the Company's randomized, multicenter, double-blind, placebo-controlled Phase 2b trial of IGV-001 in 99 patients with newly diagnosed glioblastoma (ndGBM) has been accepted for poster and rapid oral presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), taking place November 12-15, 2026 in Philadelphia. The Company also provided an update on its planned Phase 3 development of IGV-001 in ndGBM patients whose tumors had an unmethylated O6-methylguanine-DNA methyltransferase promoter (uMGMT). Patients with uMGMT ndGBM account for an estimated 55% to 60% of all ndGBM patients and they represent a biologically high-risk cohort with limited therapeutic options and poor expected outcomes with current standard-of-care approaches.

In a prespecified subgroup analysis of patients in the Phase 2b trial with uMGMT tumors (n=48), patients in the IGV-001 arm had a median overall survival (mOS) of 14.8 months, a difference of 4.2 months, or 40%, compared to a mOS of 10.6 months in the placebo arm (HR 0.60, P=0.0808). Additionally, patients in the IGV-001 arm experienced delayed deterioration of Karnofsky Performance Status (KPS) score, favorable quality-of-life measures, lower rates of severe toxicities, and reduced burden of serious adverse events as compared to the placebo arm.

“Patients with uMGMT ndGBM have an urgent need for more effective treatment options. The magnitude and consistency of the treatment effect observed across survival, functional, and patient-reported outcome measures support continued investigation of IGV-001 in the uMGMT patient population,” said J. Bradley Elder, M.D., Director, Neurosurgical Oncology, Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center and the highest enrolling investigator in the Phase 2b trial.

Future Clinical Development of IGV-001

The Company met with the U.S. Food and Drug Administration (FDA) earlier this year to discuss the Phase 2b data and the regulatory pathway for IGV-001. Following this, the Company met with FDA in July to align on the key elements of a proposed randomized, open-label Phase 3 study of IGV-001 in approximately 375 uMGMT ndGBM patients in the United States. The planned primary endpoint of this study is overall survival (OS), and the study would include an interim analysis after a specified number of patient deaths. Imvax has incorporated the feedback from FDA into the proposed final protocol for the study, which it plans to submit to FDA in the coming months.

"With the FDA’s recent feedback, we will be finalizing the protocol for a Phase 3 study focused on patients with uMGMT ndGBM, a population that has lacked meaningful treatment innovation in decades and where we saw a clinically meaningful benefit in the Phase 2b study,” said John P. Furey, Executive Chair of the Imvax Board of Directors. “We are also actively pursuing financing to support the initiation of this planned Phase 3 trial in 2027.”

SNO 2026 presentation details

• Abstract title: “Initial efficacy and safety results of a randomized, double-blind, Phase 2b study to evaluate IGV-001, an autologous cell immunotherapy, plus standard of care (SOC) versus placebo (PBO) plus SOC in adult patients with newly diagnosed glioblastoma (ndGBM)”
• Presenting author: J. Bradley Elder, M.D., Director, Neurosurgical Oncology, Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center
• Presentation type: Rapid oral and poster
• Abstract number: CTIM-05
• Location: Pennsylvania Convention Center, Philadelphia

About IGV-001 and glioblastoma

IGV-001 is an investigational, autologous biologic-device combination product candidate derived from Imvax's proprietary Goldspire^® immuno-oncology platform. The platform is designed to induce a patient-specific immune response against a broad range of tumor antigens. FDA has granted IGV-001 Fast Track designation and Orphan Drug Designation for the treatment of ndGBM. IGV-001 has not been approved by FDA or any other regulatory authority.

Glioblastoma is the most common aggressive malignant primary brain cancer in adults and has resisted meaningful treatment advances for decades. Approximately 14,000 people are diagnosed with glioblastoma each year in the United States. Current treatment generally consists of maximal safe resection followed by radiotherapy and temozolomide, with subsequent maintenance temozolomide. MGMT promoter methylation is a biomarker associated with benefit from temozolomide. Patients whose tumors have an unmethylated MGMT promoter generally derive limited benefit from temozolomide, experience shorter overall survival than patients with methylated tumors, and currently have no approved treatment specifically for uMGMT disease.

About the Phase 2b trial

The Phase 2b trial (NCT04485949) was a randomized, multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of IGV-001 in 99 patients with ndGBM at 19 U.S. sites. Participants were randomized 2:1 to IGV-001 or placebo. The trial assessed progression-free survival, overall survival and safety. In the trial, patients in the IGV-001 arm had a median overall survival (mOS) of 20.3 months, a difference of 6.3 months, or 45%, compared to a mOS of 14.0 months in the placebo arm. The median follow-up time for all patients in the study was 22 months. In a prespecified subgroup analysis of patients in the Phase 2b trial with uMGMT tumors (n=48), patients in the IGV-001 arm had a median overall survival (mOS) of 14.8 months, a difference of 4.2 months, or 40%, compared to a mOS of 10.6 months in the placebo arm. There were no drug-related serious adverse events in the treatment arm, and the safety profile seen in the Phase 2b trial is favorable, consistent with that observed in a previous Phase 1b study (n=33).

About Imvax, Inc.

Imvax is a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies through its proprietary Goldspire^® platform. Its lead candidate, IGV-001, is being developed for patients with newly diagnosed glioblastoma. Imvax is headquartered in Philadelphia. For more information, visit www.imvax.com.