Imvax Completes Phase 2b Trial Enrollment of IGV-001 and Secures Funding

Imvax, Inc., a biotechnology company focused on developing personalized immunotherapies, has announced the completion of enrollment for its Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). This randomized, multicenter, double-blind, placebo-controlled trial enrolled approximately 100 participants across 20 U.S. sites within a planned timeframe of 14 months. The primary endpoint of the trial is Progression-Free Survival (PFS), with top-line data anticipated by mid-2025.

IGV-001 is developed using Imvax's proprietary Goldspire™ platform, which utilizes a patient’s own tumor cells to trigger a broad and lasting immune response against tumors. The U.S. Food and Drug Administration (FDA) has granted IGV-001 Fast Track designation, based on Phase 1b data, acknowledging its potential to address the significant unmet medical need in this life-threatening condition.

Imvax has also successfully completed $35 million in financing, with half of the capital raised from new investors. This brings the total funds raised by the company over the past 15 months to $57 million, ensuring sufficient resources to complete the Phase 2b trial and support operations beyond the expected data readout in mid-2025.

John P. Furey, Chief Executive Officer of Imvax, expressed satisfaction with the swift enrollment, highlighting the clinical interest and efficient execution of the trial. He thanked the investigators, patients, and their families for their dedication. Furey also emphasized the significance of the FDA's Fast Track designation, noting the nearly 20-year gap since the last major advancement in glioblastoma treatment. He believes IGV-001 could provide meaningful clinical benefits for patients suffering from this deadly disease.

The Phase 2b trial aims to evaluate the safety and efficacy of IGV-001. Participants in the IGV-001 arm of the study received biodiffusion chambers containing a combination of personalized whole tumor-derived cells and an antisense oligonucleotide (IMV-001) approximately 48 hours after surgical resection. Those in the placebo arm received chambers with an inactive solution. The chambers were removed after 48 hours, and all patients subsequently received standard care, including radiotherapy and temozolomide. Key secondary endpoints of the trial include overall survival (OS) and safety.

IGV-001 is an autologous biologic-device combination derived from the Goldspire™ platform, aimed at inducing a broad and durable immune response against solid tumors. Phase 1 studies demonstrated that IGV-001 was safe and well-tolerated, with significant signals of efficacy in ndGBM patients. In the highest dose cohort of ten patients, IGV-001 showed a median PFS of 17.1 months and a median OS of 38.2 months, compared to 6.5 and 16.2 months, respectively, in historical standard-of-care treatments.

Fast Track designation by the FDA is designed to expedite the development and review of treatments that address serious conditions and unmet medical needs. It allows for early and frequent interactions with the FDA and a rolling submission of the marketing application, which can lead to priority review and accelerated approval.

Imvax, headquartered in Philadelphia, PA, is dedicated to advancing its unique immunotherapy platform, Goldspire™, to treat a variety of solid tumors. The company’s portfolio includes several programs aimed at stimulating a patient’s immune system against the entire antigen signature of their tumor, with IGV-001 being the most advanced program currently in the Phase 2b trial for newly diagnosed glioblastoma patients.