Enlivex Presents New Clinical Data Demonstrating Early Resolution of Cytokine Storms in Sepsis Patients Treated with Allocetra at the International Society for Cellular Therapy 2020 Paris Virtual Annual Meeting - Seite 2

The oral presentation, “Resolution of cytokine storm associated with sepsis by apoptotic cells (AllocetraOTS) administration,” will be delivered by Prof. Mevorach. Highlights from the presentation include:

• All patients had elevated pro- and anti-inflammatory cytokines, chemokines, and additional immune modulators that steadily decreased following Allocetra^TM treatment.
• Study subjects (N=10) had a mortality rate of 0% compared to a mortality rate of 27% in matched historical controls (N=37).
• Study subjects exhibited rapid resolution of organ dysfunction and had significantly shorter ICU stays (p<0.0001) compared to matched historical controls.
• No serious adverse events or definite treatment-related adverse events were reported with Allocetra^TM treatment.

Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, said, “We are highly encouraged by these new data from our Phase Ib trial, which provide supporting clinical data to Allocetra’s^TM mechanism of action and our upcoming Phase IIb study. The heterogenous nature of cytokine storms could potentially explain why there are no available therapies for sepsis, and underscores the rationale behind our development of Allocetra^TM, which has been designed to activate natural rebalancing pathways and have a homeostatic effect across various immune subsystems. Importantly, we believe that the post-treatment data showing the homeostatic effect of Allocetra^TM highlight its potential not only in sepsis, but also in similar pathologies associated with cytokine storms.”

STUDY DESIGN
The aim of the Phase Ib study was to determine the safety and efficacy profile and tolerability of Allocetra^TM, in subjects admitted to the emergency room with sepsis. Allocetra^TM (140x10⁶ cells/kg) was administered in either a single dose to six patients at day 1 or in two doses to four additional patients at days 1 and 3.Patients were followed for 28 days. The study subjects were also compared to historical controls hospitalized in the ICU, matched by age, gender, Sequential Organ Failure Assessment (SOFA) score, and infection source.

ABOUT ENLIVEX
Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve hyper-expression of cytokines (Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs), as well as solid tumors immune-checkpoint rebalancing.  For more information, visit http://www.enlivex.com.