Full Press Release Details
Sheba Medical Center and
Enlivex Announce Dosing of the First Patient in Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal
Metastases Arising from Solid Cancers
Nes-Ziona, Israel, July 06,
2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a a clinical-stage macrophage reprogramming
immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the first patient
has been dosed in a Phase I/II clinical trial evaluating Allocetra combined with chemotherapy in patients with peritoneal metastases
arising from solid cancer.
Peritoneal cancer, whether originating
from a primary tumor within the peritoneum or from a metastatic tumor elsewhere in the body, is a terminal disease with a poor prognosis.
Patients with peritoneal metastases are in urgent need of novel treatment options, as standard-of- care (SOC) chemotherapy currently
provides only modest survival benefits. The median survival of patients with peritoneal metastases differs based on the location of the
primary tumor but is frequently poor, with survival rates of 2.9 months, 6.5 months, and 6.9 months reported for cancers of pancreatic,
gastric, and colorectal origins, respectively.
Prof. Aviram Nissan, M.D., Head
of the Department of General and Oncological Surgery at Sheba Medical Center and Principal Investigator of the trial commented: "The
patients are operated using the Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) technology, which allows for efficient insertion
of therapeutics directly to the peritoneum. We hope that the combination of chemotherapy and Allocetra , a next-generation cell
therapy in development for oncological indications, will generate a breakthrough in the treatment of peritoneal metastases, which are
not treatable in most patients with anti-cancer drugs available today. We are eager to test this new combination with the hope of changing
the lives of patients with peritoneal metastases."
Mohammad Adileh, M.D., Attending
Surgical Oncologist, Department of Surgery and Surgical Oncology - Surgery C, and a Co-Investigator in the trial stated: "Together
with my team, I performed a ground breaking procedure in a patient with abdominal metastasis, combining a novel drug delivery system,
PIPAC, with Allocetra , the development-stage macrophage-reprogramming cell therapy produced by Enlivex. I look forward to understanding
the scope of the effect of Allocetra and its impact on the immune system in its efforts to recognize and kill malignant tumors
in the abdomen. We are excited to test this combination as a new hope for patients with peritoneal cancers."
"The initiation of our first
oncology trial is a crucial moment in Enlivex's evolution," said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex.
"We believe that it de-risks our pipeline with another avenue for value creation and positions us to substantially expand our addressable
patient population. We look forward to the trial's advancement and to expanding our oncology clinical program and would like to
thank all those who helped achieve this important milestone."
Mevorach, M.D., Chief Scientific Officer of Enlivex commented: "We believe that Allocetra has strong anti-cancer potential
in a novel mechanism. Preclinical data suggests that Allocetra rebalances macrophage populations within the tumor microenvironment
into a homeostatic state that favors anti-tumoral macrophages. This, in-turn, is expected to weaken the tumor defense mechanisms that
limit the efficacy of currently available therapies. With this novel mechanism of action, Allocetra can potentially enhance the
anti-cancer activity of a broad range of drug classes across a spectrum of highly prevalent solid cancers."
associated macrophages typically form a physical layer on top of solid cancers and induce an immunosuppressive tumor microenvironment.
This promotes cancer growth and metastasis and limits the efficacy of anti-cancer agents, which ultimately contributes to poor clinical
outcomes. Preclinical studies, including those that were recently featured at the American
Society of Clinical Oncology (ASCO) Annual Meeting and the International Society for Cell and Gene Therapy Annual Meeting, suggest
that Allocetra has the potential to synergistically combine with various anti-cancer agents to provide patients who do not respond
well to existing FDA-approved therapies with an effective treatment option.
The Phase I/II trial is a company-sponsored,
open-label, dose escalation and expansion trial that is expected to enroll a total of approximately 12 patients across four cohorts.
It is designed to evaluate the safety and potential preliminary efficacy of Allocetra combined with SOC chemotherapy in patients
with peritoneal metastases arising from solid cancer. The study will begin with two cohorts of intra-patient and intra-cohort dose escalation
to determine the maximum feasible dose (MFD) of Allocetra in this population, followed by two additional cohorts comparing administration
of Allocetra at the selected dose either before or after administration of SOC via a pressurized intraperitoneal aerosol chemotherapy
procedure (PIPAC; a technique applied when patients are not eligible to receive the standard treatment due to a considerable tumor load,
large quantities of persistent ascites, or other circumstances).
Intraperitoneally delivered Allocetra
and SOC chemotherapy administered via PIPAC will be given to patients every six weeks. Systemic chemotherapy will also be administered
per the treating oncologist's plan. The primary endpoint is the number and severity of Allocetra-related adverse events and serious
adverse events during the 16-week period, starting from the first administration of study treatment. Secondary endpoints include efficacy
assessments, such as best overall response rate (ORR), progression-free survival, and overall survival. Changes from baseline in macrophage
and immune cell characteristics in peritoneal fluid and tissues will also be assessed as an exploratory endpoint.
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.
ABOUT SHEBA MEDICAL CENTER
The largest and most comprehensive
medical center in the Middle East, Sheba Medical Center, Tel HaShomer is generating global impact through its medical care, research
and healthcare transformation. Sheba's City of Health boasts an acute-care hospital, rehabilitation hospital, research and innovation
hubs, medical simulation center and center for disaster response on one comprehensive campus in the center of Israel. A university teaching
hospital affiliated with the Sackler School of Medicine at Tel-Aviv University, Sheba is shaping the future of healthcare, educating
the next generation of care providers. Sheba serves as a true hospital without borders, welcoming patients and healthcare professionals
from all over the world and consistently providing the highest-level medical care to all in need. Sheba has been ranked a top ten hospital
in the world by Newsweek four years in a row (2019, 2020, 2021, 2022).
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 state1. 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.
Safe 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.