Newswise — HACKENSACK, N.J., JANUARY 15, 2020 — Investigators at John Theurer Cancer Center at Hackensack University Medical Center in New Jersey are participating in a first-in-patients clinical trial assessing VE800, a novel bacteria-containing therapy, in combination with the immunotherapy drug nivolumab. Laboratory research has suggested that VE800 may enhance the effectiveness of drugs like nivolumab.

Nivolumab belongs to a class of drugs called checkpoint inhibitors, which also include pembrolizumab and ipilimumab. Cancer cells use certain proteins to hide from or block the immune system, preventing the elimination of cancer cells by the immune system. The category of drugs called checkpoint inhibitors can take the brakes off the immune response and enable the it to detect and destroy cancer cells. Based on their impressive activity, checkpoint inhibitors have been approved by the FDA and become part of the standard of care for more than 14 different types of cancer, including melanoma, lung cancer, head and neck cancer, bladder cancer, cervical cancer, liver cancer, stomach cancer, breast cancer, and lymphoma.

Though immune blockade has been a game-changer, some patients still do not respond to this treatment or eventually relapse. Efforts to understand why some patients respond more than others have revealed that the answer might be in the microbiome: the trillions of bacteria and other tiny organisms that live in our bodies, the bulk of it being the intestinal flora or “gut microbiome.” Growing evidence has shown that the microbiome is an important contributor to human health, playing a role in a number of diseases or conditions including obesity, diabetes, and inflammation, among others. Remarkably, studies have revealed differences in microbiome composition between responders and non-responders to checkpoint inhibitors. This is due to the ability of the microbiome to modulate the immune system and affect the microenvironment of tumors and the immune response.

VE800 is an investigational therapy made up of 11 "friendly" bacterial strains that act in concert to activate cytotoxic CD8+ T cells — immune cells which form the vanguard of the immune system's response to tumors and a key driver of effective immunotherapies. In preclinical studies, VE800 enhanced the ability of these T cells to get into tumors, promoting the suppression of tumor growth and potentially enhancing survival.

The phase I study, which is being conducted at John Theurer Cancer Center and other centers across the United States, will evaluate the safety and clinical activity of VE800 in combination with nivolumab in patients with advanced or metastatic melanoma, gastric/gastroesophageal junction adenocarcinoma (esophagus/stomach cancer), or a type of colon cancer called microsatellite-stable colorectal cancer. The first results are anticipated in 2021.

"While immunotherapy has revolutionized cancer care, there are still many patients who are not doing as well as we would like with these treatments," explained Martin E. Gutierrez, M.D., Director of Drug Discovery and the Phase I Unit and Chief of Thoracic Oncology at John Theurer Cancer Center. "Modifying the microbiome in combination with immunotherapy is a provocative concept. John Theurer Cancer Center is excited to be part of this pivotal study."

For more information about this study and to inquire about enrollment, please call 551-996-5855.

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About John Theurer Cancer Center at Hackensack University Medical Center

John Theurer Cancer Center at Hackensack University Medical Center is New Jersey’s largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 15 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. John Theurer Cancer Center is a member of the Georgetown Lombardi Comprehensive Cancer Center Consortium, one of just 16 NCI-approved cancer research consortia based at the nation’s most prestigious institutions. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities. For additional information, please visit