Pipeline

Glioblastoma multiforme (glioblastoma, or GBM) is a brain cancer that is nearly always fatal. It is the most common malignant tumor that affects the central nervous system (CNS) and overall the third most common tumor of the brain and CNS. A person newly diagnosed with GBM has a median overall survival (OS) or life expectancy of 12 to 15 months, and less than 6% of GBM patients survive to five years after diagnosis. The current standard of care treatment is based on surgery to remove as much of the tumor as possible. Surgery is typically followed by radiotherapy and chemotherapy. IGV-001 is Imvax’s most advanced product candidate, in development to treat GBM. It has completed a Phase 1a in recurrent glioblastoma and a Phase 1b in newly diagnosed glioblastoma (ndGBM) which in total dosed 46 patients. In the Phase 1b study, IGV-001 was well tolerated and multiple efficacy signals were observed. These included significant improvements in progression-free survival, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response. In March 2023, Imvax initiated a randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in ndGBM patients. The primary endpoint of the trial is progression-free survival (PFS) and key secondary endpoints include overall survival (OS) and safety.  The trial enrolled approximately 100 participants in a 2:1 randomization across 20 sites in the United States and top-line PFS data is expected to be available in mid-2025. In 2024, the U.S. Food and Drug Administration granted Fast Track designation to IGV-001 for the treatment of ndGBM.  Back to Pipeline

Endometrial cancer is the most common type of uterine cancer. The American Cancer Society estimates that there will be roughly 66,000 new cases of endometrial cancer in the United States this year, with an estimated number of deaths of almost 13,000. Endometrial cancers primarily affect post-menopausal women and the average age of diagnosis is 60. Imvax is developing IEC-001 for treatment of endometrial cancer. Preclinical studies are ongoing. Back to Pipeline

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. It is estimated that approximately 42,000 new cases will be diagnosed in the U.S. in 2021 per the American Cancer Society. The five-year survival rate for patients diagnosed with HCC is about 20%. Imvax is developing IHC-001 for the treatment of HCC. Preclinical studies are ongoing. Back to Pipeline

Urothelial cancer is by far the most common type of bladder cancer. The American Cancer Society estimates that 81,180 new cases of bladder cancer will be identified in 2022 in the United States, with 75% of those cases occurring in men. Approximately 17,000 Americans will die from bladder cancer this year. Imvax is developing IUC-001 for treatment of urothelial cancer. Preclinical studies are ongoing. Back to Pipeline

Ovarian cancer is the fifth most deadly cancer among women in the U.S. according to the American Cancer Society. The ACS estimates that approximately 22,000 women in the U.S. are diagnosed annually, and approximately 14,000 women died of the disease in the U.S. in 2020. Based on recent data, the five-year survival rate for Stage III-IV ovarian cancer is 25%. Imvax is developing IOC-001 for the treatment of ovarian cancer. Preclinical studies are ongoing. Back to Pipeline