On January 26, 2021 Imvax, Inc., an emerging oncology leader that is revolutionizing immunotherapy for patients with Glioblastoma Multiforme (GBM), reported publication of Phase 1b clinical trial results in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Imvax, JAN 26, 2021, View Source [SID1234574319]). The article — "Phase1b Clinical Trial of IGV-001 for patients with Newly Diagnosed Glioblastoma" — is available online.
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IGV-001 is a first-in-class personalized immunotherapy that uses the patient’s own tumor cells combined with an antisense molecule to induce a potent immune response. The treatment comprises irradiated autologous glioma cells with an antisense oligodeoxynucleotide directed at the IGF-1R (Insulin-like Growth Factor type one Receptor) named IMV-001. Delivered through an implantable and removable bio-diffusion chamber, antigenic products are released and initiate both an innate and adaptive response.
The four cohorts in this Phase 1b study represent 33 patients accrued over three years at Thomas Jefferson University. The optimal dose cohort demonstrated progression-free survival at 17.1 months and overall survival at just below 22 months. The methylated subgroup demonstrated a notable increase in progression-free survival at 38.4 months. The average life expectancy for a patient with GBM is 15-16 months. Evidence of immune activation was noted.
"This study demonstrates that an antigen inclusive approach can benefit GBM patients, both in terms of survival and quality of life," said David W. Andrews, M.D., Founder and Chief Medical Officer of Imvax and the Anthony Alfred Chiurco MD Professor of Neurosurgery at Jefferson. "These results show that progression-free survival was in fact significantly improved — almost threefold above the reported progression-free survival for the standard of care."
"We are addressing the great unmet need in the battle against GBM through the development of IGV-001," said John Furey, CEO of Imvax. "I’m proud of the strides our team is making by establishing proof of concept and of what lies ahead as we embark on our Phase 2 study."
"The strengths of this study are significant and noteworthy including the innovative approach, which was granted ‘Orphan Drug’ designation by the FDA in 2017, the impressive increase in PFS, and the various immunological correlations," said Andrew E. Sloan, MD, FAANS, FACS, Director of the Brain Tumor and Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at the Seidman Cancer Center and the Neurological Institute of the University Hospitals, Cleveland, OH. "This is a highly meritorious study of a novel technique that demonstrates statistically-significant clinical benefit, even as a stage 1b study, for a disease that is universally fatal. The paper adds significantly to the field and is an exciting development."
The Phase 2b study is to begin in the first half of 2021.