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Enlivex Receives Allocetra IND Clearance From The U.S. Food And Drug Administration For Treatment Of Patients with Advanced Solid Malignancies
IND filing followed encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant
About this update from Enlivex Ltd.
[{"type":"text","content":"IND filing followed encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra™ was combined with a PD1 checkpoint inhibitor in a murine model of ovarian cancer, and additional models that demonstrated statistically significant survival benefit when Allocetra™ was combined with a PD1 or CTLA-4 checkpoint inhibitor in a murine model of peritoneal mesotheliomaThe protocol of the IND includes intravenous administration of frozen-formulation Allocetra™, stand-alone, and in combination with a PD1 checkpoint inhibitor, to a study population that encompasses adult patients with advanced, unresectable or metastatic solid tumors that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for, or have declined additional standard-of-care systemic therapy Nes-Ziona, Israel, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study Allocetra™ in patients with advanced solid malignancies. The FDA’s Phase I/II clearance follows a recent announcement by the Company that the first patient has been dosed in a Phase I/II multi-center clinical trial in Israel designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra™ stand-alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors. Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, stated \"We are pleased with the FDA’s regulatory clearance for our IND. The formal initiation of clinical development of AllocetraTM for oncology indications in the United States represents a significant milestone for Enlivex. We believe that AllocetraTM has the potential to provide a paradigm shift in the treatment of advanced solid tumors, and we look forward to observing safety and potential indication of effect in patients, who we expect to enroll in several open-label Company-sponsored and investigator-initiated oncology trials during 2023.” ABOUT ALLOCETRA™ Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophage...