Enlivex Receives Allocetra IND Clearance From the US FDA for Treatment of Patients With Advanced Solid Malignancies
Enlivex Therapeutics Ltd. recently announced the US FDA has cleared an Investigational New Drug (IND) application to study Allocetra in patients with advanced solid malignancies. The FDA’s Phase 1/2 clearance follows a recent announcement by the company that the first patient has been dosed in a Phase 1/2 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, PhD, Chief Executive Officer of Enlivex, said “We are pleased with the FDA’s regulatory clearance for our IND. The formal initiation of clinical development of Allocetra for oncology indications in the US represents a significant milestone for Enlivex. We believe that Allocetra 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.”
Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as “unmet medical needs”, as a stand-alone therapy or in combination with leading therapeutic agents.
Enlivex is a clinical-stage macrophage reprogramming immunotherapy company developing Allocetra, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.
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