Imvax Announces Positive Results from Clinical Trial of Novel IGV-001 Autologous Cell Vaccine in Treating Patients with Newly Diagnosed Glioblastoma

In Clinical Trials by Barbara Jacoby

Source: Globe Newswire

From: apnews.co

Median overall survival was 21.9 months for highest vaccine dose vs. 14.6 months in published standard of care studies

Median progression-free survival was 10.4 months vs. 6.9 and 5.4 months in published standard of care studies

Imvax, Inc., a clinical-stage biotechnology company focused on the development of novel patient-specific vaccines and immunotherapy strategies, today announced positive results from an ongoing Phase 1b clinical trial that demonstrate treatment with IGV-001, the Company’s novel autologous tumor cell vaccine, outperformed standard of care (SOC) with prolonged overall survival (OS) and progression-free survival (PFS) in patients with newly diagnosed glioblastoma multiforme (GBM). The results, which were presented today in an oral presentation during the Advances in Novel Immunotherapeutics session at the American Association for Cancer Research (AACR) Annual Meeting 2019, support the continued development of a new immunotherapy paradigm for the treatment of GBM.

“Our results clearly demonstrate that this new investigational vaccine shows promise when compared to standard of care therapy as currently practiced,” said neurosurgeon David W. Andrews, M.D., co-founder, Chief Medical Officer and interim Chief Executive Officer of Imvax, and Anthony Alfred Chiurco, MD Professor of Neurological Surgery, Vice Chair of Clinical Services at the Vickie and Jack Farber Institute for Neuroscience at Jefferson.

The Phase 1b trial evaluated the safety and efficacy of IGV-001, an autologous vaccine made from patients’ tumor cells and an antisense formulation, in adults with newly diagnosed GBM. Thirty-three patients received one of four vaccine exposures. SOC treatment (i.e., radiotherapy and temozolomide) was initiated four to six weeks after vaccine administration. The primary endpoint was safety and the secondary endpoint was tumor response. Exploratory objectives included assessment of PFS, OS and immune markers. A historical comparator group comprised of 35 newly diagnosed GBM patients treated at the same center evaluated SOC alone.

Dr. Andrews said, “The Imvax vaccine demonstrated striking tumor regression in over one-third of trial patients that was associated with clinical improvements. We initiated the Phase 1b trial in 2015 and are pleased to report that eleven patients who participated in the trial have returned to active, vigorous lives.”

Treatment with IGV-001 was well tolerated, and 15 of 33 patients (45.5 %) experienced no tumor growth as of March 1, 2019. Moreover, the cohort treated with the highest vaccine dose demonstrated an improvement of 7.3 months in OS (21.9 months vs. 14.6 months per Stupp1) and 3.5 months in PFS (10.4 months vs. 6.9 months when compared against the historical comparator group; p=0.031) against SOC treatment alone.

The most prominent survival statistics included those patients with DNA methylation of the MGMT promoter which favors temozolomide treatment. However, PFS for methylated patients was three-fold longer (30.9 months vs. 10.3 months for historic SOC patients per Hegi2). This finding is under further investigation for its benefit.

“Cancers originate as a disease of the cell but their progression is often associated with disorders of the immune system,” said immunologist D. Craig Hooper, co-founder and Chief Scientific Officer of Imvax, and Researcher, Sidney Kimmel Cancer Center at Jefferson Health. “This is certainly true for patients with glioblastoma multiforme where the growth of cells that should be effective targets for therapeutic immunity appears to be dependent upon altered immune function. Our approach is to inhibit aberrant immune mechanisms induced by the tumor cells at the same time as vaccinating with the patient’s own tumor antigens. Restoration of the patient’s ability to mediate an appropriate immune response together with the use of a truly personalized array of tumor antigens provides us with the best chance of generating effective anti-tumor immunity.”

Andrew E. Sloan, M.D., Professor and Vice Chair Department of Neurological Surgery at University Hospitals, Cleveland Medical Center, and Director, Brain Tumor and Neuro-Oncology Center, Cleveland Medical Center & the Center of Excellence for Translational Neuro-Oncology, UH Seidman Cancer Center, said “The data presented at AACR suggests that IGV-001 prolonged both progression-free and overall survival, particularly in the group of patients with methylated MGMT. Notably, it appears to work in both patients with imaging complete resection as well as in patients with subtotal resection, which has been a challenge in previous generations of immunotherapy for GBM. I look forward to further evaluation of this vaccine as a novel treatment for glioblastoma.” Dr. Sloan played no part in the clinical trial, nor does he have an association with either Imvax or Thomas Jefferson University.

IGV-001 has been developed over the past 20 years at Thomas Jefferson University Hospital in Philadelphia, where three Phase 1 trials directed by Drs. Andrews and Hooper have now demonstrated efficacy and safety.

Dr. Andrews added, “After devoting nearly two decades to this novel vaccine’s research and development, we believe this lethal cancer is one significant step closer to becoming an effectively managed condition. We look forward to initiating a multi-center Phase 2 clinical trial later this year.”

References:1. Stupp R, et al (2009). Lancet Oncology, 10(5), 459–466.2. Hegi ME, et al (2005) N Engl J Med, 352(10), 997-1003.

About IGV-001

IGV-001 is a first-in-class autologous vaccine in development for the treatment of newly diagnosed glioblastoma multiforme (GBM), a lethal and common type of brain tumor. Based on early clinical research, one treatment with IGV-001 has the potential to trigger a multi-pronged immune response, including a short-term innate immune response followed by longer-term powerful adaptive immune activity, that is selectively directed at the patients’ tumor cells.

IGV-001 has been granted orphan drug designation for the treatment of malignant glioma by the U.S. Food and Drug Administration and the European Medicines Agency.

About Imvax, Inc.

Imvax is a discovery and clinical-stage biotechnology company focused on the development of novel patient-specific vaccines and immunotherapy strategies for the treatment of malignant gliomas and other cancers with unmet medical needs. Imvax’s lead product candidate, IGV-001, is an autologous tumor cell vaccine that delivers a multi-pronged response against tumor cells by leveraging the patient’s immune system as a defense mechanism.