PHILADELPHIA--(BUSINESS WIRE)--Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, today announced the completion of enrollment in its randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). IGV-001 is derived from Imvax’s proprietary Goldspire™ immuno-oncology platform, which is designed to use a patient’s own tumor cells to induce a broad and durable immune response against tumors. The primary endpoint of the Phase 2b trial is Progression Free Survival (PFS) and top-line data is expected by mid-2025.
Separately, the Company today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IGV-001 for the treatment of ndGBM based on the Company’s existing Phase 1b data supporting its therapeutic potential in this underserved and life-threatening condition.
Imvax also announced the closing of an approximately $35 million financing round, with half of the capital coming from new investors. Over the past 15 months, the Company has raised $57 million to support the completion of the Phase 2b trial.
“We are very pleased to announce full enrollment of the trial in less than 14 months, which speaks to both the clinical interest in this potential therapy and the efficient execution of our novel approach to treating GBM patients,” said John P. Furey, Chief Executive Officer. “We are grateful to the investigators, patients, and their families for their commitment to this study and look forward to seeing top-line data next year. We are also delighted that the FDA has granted Fast Track designation to IGV-001. The last significant advancement in the standard of care for GBM – about an 8-week improvement in PFS – was nearly 20 years ago, highlighting the need for continued innovation and treatment options. We believe IGV-001 may offer meaningful clinical benefit for patients diagnosed with this deadly disease.”
Mr. Furey continued, “We are grateful for the support of both existing and multiple new investors in our recent fundraising, which reflects their belief in the promise of IGV-001 and their commitment to patients facing a GBM diagnosis. We now have sufficient resources to support the completion of the trial and carry us beyond the reporting of top-line results in mid-2025.”
About the Phase 2b Trial
The Phase 2b clinical trial is a randomized, multicenter, double-blind, placebo-controlled study (NCT04485949) designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial enrolled approximately 100 participants in a 2:1 randomization across 20 sites in the United States. Approximately 48 hours after surgical resection, participants in the IGV-001 arm were implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers contained an inactive solution only. In both arms, the biodiffusion chambers were explanted approximately 48 hours later, and after six weeks all patients were treated with standard of care (adjuvant radiotherapy and temozolomide followed by maintenance temozolomide). The primary endpoint of the trial is progression-free survival (PFS) and key secondary endpoints include overall survival (OS) and safety.
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 ndGBM study 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.
About Fast Track Designation
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of investigational treatments that have the potential to treat serious conditions and address recognized areas of unmet medical need. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the product candidate’s development plan in addition to a rolling submission of the marketing application. Product candidates with Fast Track designation also may be eligible for priority review and accelerated approval.
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.
