In late June, Sheba Medical Center and Israeli company Enlivex Therapeutics Ltd. announced that the first patient has been dosed in Phase I/II clinical trial for new cancer treatment. The drug, to be used in conjunction with chemotherapy, is called Allocetra™.
Enlivex is a Ness-Ziona-based biotech company specializing in macrophage reprogramming immunotherapy. Macrophages are white blood cells that consume cancer cells and other foreign entities; they are an important part of the body's immune system.
“The initiation of our first oncology trial is a crucial moment in Enlivex’s evolution,” said CEO Oren Hershkovitz, Ph.D. “We believe that it de-risks our pipeline with another avenue for value creation and positions us to substantially expand our addressable patient population. We look forward to the trial’s advancement and to expanding our oncology clinical program and would like to thank all those who helped achieve this important milestone.”
Allocetra™, the drug in question, is specifically designed for the treatment of patients with peritoneal cancer — cancer of the membrane lining much of the abdomen. Such growths, whether considered primary tumors or metastatic growths from tumors elsewhere in the body, have depressing prognoses. Individuals with peritoneal cancers typically live no more than seven months post-diagnosis.
"We hope that the combination of chemotherapy and Allocetra™, a next-generation cell therapy in development for oncological indications, will generate a breakthrough in the treatment of peritoneal metastases."
Prof. Aviram Nissan, M.D.
“The patients are operated using the Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) technology, which allows for efficient insertion of therapeutics directly to the peritoneum," according to Prof. Aviram Nissan, M.D., Head of the Department of General and Oncological Surgery at Sheba Medical Center and principal investigator of the trial.
"We hope that the combination of chemotherapy and Allocetra™, next-generation cell therapy in development for oncological indications, will generate a breakthrough in the treatment of peritoneal metastases, which are not treatable in most patients with anticancer drugs available today," he said. "We are eager to test this new combination with the hope of changing the lives of patients with peritoneal metastases."
Trial projections
The trial is expected to enlist approximately 12 patients and will evaluate the practical potential of Allocetra™. The drug will be administered via PIPAC every six weeks, alongside chemotherapy according to the patient's existing treatment plan.
Prof. Dror Mevorach, M.D., Chief Scientific Officer of Enlivex projected: “We believe that Allocetra™ has strong anti-cancer potential in a novel mechanism. Preclinical data suggests that Allocetra™ rebalances macrophage populations within the tumor microenvironment into a homeostatic state that favors anti-tumoral macrophages.
"This, in turn, is expected to weaken the tumor defense mechanisms that limit the efficacy of currently available therapies. With this novel mechanism of action, Allocetra™ can potentially enhance the anti-cancer activity of a broad range of drug classes across a spectrum of highly prevalent solid cancers.”