Full Press Release Details
Announces Clinical Collaboration to Evaluate Combinations of Allocetra and PD-1 Inhibitor Tislelizumab for Patients with Solid Tumors
Israel, April 3, 2023 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, "Enlivex"), a
clinical-stage macrophage reprogramming immunotherapy company, today announced a clinical collaboration with BeiGene. to evaluate
the safety and efficacy of Allocetra , an investigational macrophage-reprogramming cell therapy, in combination with
tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment of patients with advanced-stage solid tumors.
are excited to explore the potential of Allocetra in combination with tislelizumab, a potentially differentiated PD-1 inhibitor,"
said Shai Novik, Executive Chairman of Enlivex. "We look forward to integrating tislelizumab into our ongoing Phase I/II clinical
approaches for fighting difficult-to-treat cancers historically have proven to be important in the delivery of better treatments to patients",
said Oren Hershkovitz, Ph.D., CEO of Enlivex. "We believe that the preclinical data observed to date for Allocetra, with its unique
macrophage-modulation properties, and immune checkpoints, support the evaluation of the combination for the treatment of patients with
the tislelizumab-Allocetra combinations."
the terms of the clinical collaboration agreement, Enlivex has agreed to amend its ongoing Phase I/II trial in patients with advanced-stage
solid tumors to include evaluation of Allocetra in combination with tislelizumab. The Phase I/II trial is a multicenter, open-label,
dose escalation trial that is expected to enroll up to 48 patients with advanced solid tumors across two trial stages. Stage 1 of the
trial will examine escalating doses of Allocetra monotherapy administered intravenously (IV) or intraperitoneally (IP) once a
week for three consecutive weeks. Stage 2 will evaluate escalating doses of Allocetra administered IV or IP and combined with anti-PD1
therapy. BeiGene will provide the clinical supply of tislelizumab for the trial.
(BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc R on macrophages.
In pre-clinical studies, binding to Fc R on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies
through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is being developed as a monotherapy
and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
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.
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.
Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects,"
"plans," "projects," "will," "may," "anticipates," "believes,"
"should," "would", "could," "intends," "estimates," "suggests,"
"has the potential to" and other words of similar meaning, including statements regarding expected cash balances, market
opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities
for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties
that may affect Enlivex's business and prospects, including the risks that Enlivex may not succeed in generating
any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or
effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied
or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties
that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in
humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage
trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product
line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional
time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive
products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition
to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other
factors discussed in Enlivex's filings with the Securities and Exchange Commission, including in the Company's
most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained
in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking
statements, except as required under applicable law.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.