Business
Enlivex Initiates Design and Construction Process for a New cGMP Allocetra Manufacturing Plant
New cGMP manufacturing plant designed to support additional clinical- and initial commercial-scale production of Allocetra Nes Ziona, Israel, July 12, 2021
About this update from Enlivex Ltd.
[{"type":"text","content":"New cGMP manufacturing plant designed to support additional clinical- and initial commercial-scale production of Allocetra\nNes Ziona, Israel, July 12, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has initiated the design and construction process for a new wholly owned manufacturing plant in Israel. Upon completion, this cGMP plant will provide additional manufacturing capacity for AllocetraTM, the Company’s immunotherapy product candidate. Enlivex intends to use the additional manufacturing capacity to support ongoing clinical trials, future clinical trials and initial commercial production of AllocetraTM that may occur if Enlivex receives applicable regulatory approvals. The planned new facility will initially be approximately 17,000 square feet, and will have the ability to be expanded to approximately 21,500 square feet in the future. “The planned expansion of our manufacturing capacity represents an important milestone that we expect will position Enlivex at a different level of readiness for larger clinical trials and potential initiation of commercial activities,” said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex. “It will allow us to remain well prepared as we continue to advance AllocetraTM towards regulatory approval in sepsis and COVID-19 and work to leverage its broadly applicable mechanism of action to expand our planned clinical pipeline into solid tumors. We are very pleased with the progress these programs have been making and look forward to the construction of our new facility, which will be a critical component of the infrastructure needed to support their continued advancement.” ABOUT ALLOCETRATM AllocetraTM 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, COVID-19 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, AllocetraTM 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...