** Sponsored by Imvax. This content is not an endorsement from the ABTA.**
Imvax is a pioneering clinical biotechnology company developing personalized cancer treatments specifically designed for glioblastoma (GBM) patients. At the core of its mission is a commitment to improving patient outcomes through innovative therapies. Imvax’s lead product candidate, IGV-001, is an advanced treatment targeting newly diagnosed GBM (ndGBM) patients. This approach is part of Imvax’s cutting-edge Goldspire™ immuno-oncology platform, which uses the patient’s own tumor cells to stimulate a broad and durable immune response, providing a tailored and potentially transformative solution for this aggressive cancer.
A Unique Approach: The IGV-001 Clinical Trial
Imvax recently concluded patient enrollment for a Phase 2b clinical trial of IGV-001 in ndGBM. The trial is a significant step in understanding how IGV-001 can impact patient health outcomes. It is a randomized, multicenter, double-blind, and placebo-controlled study involving around 100 patients across 20 sites in the United States.
Participants undergo surgical resection, after which those in the IGV-001 arm receive biodiffusion chambers implanted with a mix of personalized whole tumor-derived cells combined with an antisense oligonucleotide. The placebo group receives chambers with an inactive solution. These chambers are removed approximately 48 hours later, and all patients receive the standard of care, including radiotherapy and temozolomide. The primary goal of the trial is to assess progression-free survival, with other key measures including overall survival and safety. Top-line results are expected in mid-2025, providing hope for many patients and their families.
Promising Early Results and FDA Fast Track Designation
In an earlier Phase 1b study, IGV-001 demonstrated encouraging results. It was shown to be safe and well-tolerated, with multiple efficacy signals such as improvements in progression-free survival and visible tumor response. Biomarker changes supported an immune response, laying the groundwork for the current Phase 2b study. These promising findings also led the U.S. Food and Drug Administration (FDA) to grant IGV-001 Fast Track designation, emphasizing its potential to address the unmet needs of GBM patients. Fast Track is an FDA process designed to accelerate the development and review of new therapies that have the potential to treat serious conditions, offering a sense of urgency and hope to those battling GBM.
A Partner in the GBM Community
Beyond clinical trials, Imvax remains committed to the GBM community. The company is a Corporate Partner of the American Brain Tumor Association (ABTA), actively participating in initiatives that improve the lives of brain tumor patients and their families. Imvax attends the ABTA National Conference, the largest brain tumor conference in the U.S., providing support to patients, caregivers, and survivors. Additionally, Imvax sponsors and takes part in ABTA’s Breakthrough for Brain Tumors 5K Run & Walk events, raising essential funds and awareness for brain tumor research and patient services.
Imvax’s partnership with the ABTA underscores its dedication to advancing treatment options for GBM patients. By developing IGV-001, Imvax is hopeful that it can deliver a personalized immunotherapy solution that brings meaningful benefits to those diagnosed with this life-threatening condition.
To learn more about Imvax and its ongoing efforts to revolutionize GBM treatment, visit www.imvax.com.
