Imvax announces positive results from its clinical trial on a novel autologous cell vaccine IGV-001 for the treatment of patients with newly diagnosed glioblastoma

Median overall survival was 21.9 months for the highest vaccine dose compared with 14.6 months In published studies on standards of care

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

Results Presented Today at the 2019 Annual Meeting of the American Association for Cancer Research (AACR)

ATLANTA, March 31, 2019 (GLOBE NEWSWIRE) – Imvax, Inc., a clinical-stage biotechnology company specializing in the development of innovative vaccines and patient-specific immunotherapy strategies, announced today the positive results. of a Phase 1b Clinical Trial The treatment with IGV-001, the company's new autologous tumor cell-based vaccine, outperformed the standard of care (SOC) with extended overall survival and survival without progression (SSP) in patients with newly diagnosed glioblastoma multiforme (GBM). The findings, which were presented today during an oral presentation at the session on Advances in Immunotherapeutics at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) ), support the further development of a new paradigm of immunotherapy for the treatment of GBM.

"Our results clearly demonstrate that this new experimental vaccine is promising compared to the standard treatment currently used," said neurosurgeon David W. Andrews, MD, co-founder, Acting Chief Medical Officer and CEO of Imvax, and Anthony Alfred Chiurco, MD Professor of Neurological Surgery, Vice President of Clinical Services at the Vickie Institute of Neuroscience and Jack Farber at Jefferson.

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

Dr. Andrews said, "The Imvax vaccine demonstrated striking tumor regression in more than one-third of the study patients, badociated with clinical improvements. We launched the Phase 1b trial in 2015 and are pleased to announce that eleven patients who participated in the trial have resumed an active and vigorous life. "

IGV-001 treatment was well tolerated. As of March 1, 2019, 15 out of 33 patients (45.5%) had no tumor growth. In addition, the cohort treated with the highest vaccine dose showed an improvement of 7.3 months in SA (21.9 months). 14.6 months by Stupp¹) and 3.5 months in PFS (10.4 months vs 6.9 months compared to the historical comparison group, p = 0.031) versus treatment with SOC only.

The most important survival statistics included patients with methylation of the MGMT promoter DNA that promotes treatment with temozolomide. However, progression-free survival in methylated patients was three times longer (30.9 months compared with 10.3 months for patients with previous COS per Hegi hour).²). This discovery is the subject of further investigation to his advantage.

"Cancers originate from cell disease, but their progression is often badociated with immune system disorders," said immunologist D. Craig Hooper, co-founder and scientific director of Imvax, and researcher at the 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 seems to depend on an impairment of immune function. Our approach is to inhibit the aberrant immune mechanisms induced by tumor cells at the same time as vaccination with the patient's tumor antigens. Restoring the patient's ability to induce an appropriate immune response, as well as the use of a truly personalized set of tumor antigens, offers us the best chance of generating effective anti-tumor immunity. "

Andrew E. Sloan, MD, Professor and Vice President of the Department of Neurological Surgery at University Hospitals, Cleveland Medical Center, and Director of the Center for Brain Tumor and Neuro-Oncology Research, Cleveland Medical Center and Center for Excellence in translational neuro-oncology, UH Seidman Cancer Center, said: "The data presented at the AACR suggest that IGV-001 has extended progression-free survival and overall survival, particularly in the patient group. with methylated MGMT. In particular, it seems to work both in patients with complete resection with imaging and in patients with subtotal resection, which was a challenge for previous generations of GBM immunotherapy. I look forward to deepening the evaluation of this vaccine as a new treatment for glioblastoma. Dr. Sloan played no role in the clinical trial and was not badociated with Imvax University or Thomas Jefferson University.

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

Dr. Andrews added, "After nearly two decades of research and development of this new vaccine, we believe that this deadly cancer is an important step towards becoming an effectively managed state. We look forward to launching a multicenter 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-clbad autologous vaccine for the treatment of newly diagnosed glioblastoma multiforme (GBM), a type of lethal and common brain tumor. According to preliminary clinical research, treatment with IGV-001 could trigger a multi-pronged immune response, including an innate immune response in the short term followed by a potent long-term adaptive immune activity, selectively directed to the patient. tumor cells.

IGV-001 has received the orphan drug designation for the treatment of malignant glioma by the US 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 new vaccines and patient-specific immunotherapy strategies for the treatment of malignant gliomas and other cancers with medical needs. not satisfied. The main product candidate of Imvax, IGV-001, is an autologous tumor cell-based vaccine that provides a multi-pronged response against tumor cells by relying on the patient's immune system as a mechanism defense.

Imvax is based in Philadelphia, Pennsylvania. For more information, please visit www.Imvax.com.

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