Biotechnology company Imvax has secured $29 million in new financing from existing investors to support its ongoing Phase IIb clinical trial of IGV-001, an innovative treatment for newly diagnosed glioblastoma (ndGBM). This latest funding round brings the company's total capital raised to $86 million over the past 21 months, demonstrating strong investor confidence in the therapy's potential.
The randomized, multi-center, placebo-controlled, double-blind Phase IIb trial has successfully enrolled approximately 100 participants across 20 clinical sites in the United States. The study is evaluating IGV-001, an autologous biologic-device combination product that represents a novel approach to treating glioblastoma, the most aggressive and common form of brain cancer affecting approximately 14,000 Americans annually.
Treatment Protocol and Trial Design
The experimental therapy involves a unique delivery system where patients in the treatment arm receive biodiffusion chambers containing personalized tumor cells combined with an antisense oligonucleotide. These chambers are implanted within 48 hours following surgical tumor resection. Control group participants receive chambers containing an inactive solution. After six weeks and chamber explantation, all participants proceed with standard-of-care treatment.
The trial's primary endpoint focuses on progression-free survival (PFS), with overall survival (OS) and safety serving as key secondary endpoints. John Furey, CEO of Imvax, expressed gratitude for the continued investor support, stating, "We are grateful for the support of our existing investors in this latest fundraising, which reflects their continued belief in the promise of IGV-001 for the thousands of patients facing a GBM diagnosis each year."
Promising Early Clinical Evidence
The advancement to Phase IIb follows encouraging results from earlier clinical studies. Phase I trials demonstrated that IGV-001 was safe and well-tolerated by patients. More significantly, the Phase Ib study showed notable efficacy signals, with patients experiencing meaningful improvements in overall survival, progression-free survival, and radiographic evidence of tumor response. The study also revealed biomarker changes indicating an immune response to the treatment.
Particularly noteworthy was the performance in a high-dose cohort of ten Stupp-eligible newly diagnosed glioblastoma patients, where the median progression-free survival reached 17.1 months. This represents a substantial improvement over the historical standard-of-care treatment, which typically achieves a median PFS of 6.5 months.
Looking Forward
With patient enrollment completed in May 2024, Imvax remains on schedule to report top-line results from the Phase IIb trial in mid-2025. The new financing provides operational flexibility extending beyond the anticipated data readout, positioning the company to advance the development program based on the trial's outcomes.
The successful development of IGV-001 could represent a significant advancement in the treatment of glioblastoma, a devastating disease with limited therapeutic options and poor survival rates. The therapy's innovative approach, combining personalized medicine with a novel delivery system, may offer new hope for patients facing this challenging diagnosis.
