Full Press Release Details
Enlivex Announces New Preclinical Data in Murine
Mesothelioma Model Showing a Substantial Survival Benefit with Allocetra as Monotherapy and in Combination with Cisplatin at the ESMO
Nes-Ziona, Israel, September 12, 2022 (GLOBE
NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming
immunotherapy company, today announced new preclinical data in a murine mesothelioma model showing a substantial and statistically significant
survival benefit when Allocetra is combined with the chemotherapeutic agent, cisplatin. The data are featured in a poster being
presented at the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place both virtually and in-person at the
Paris Expo Porte de Versailles in Paris, France from September 9, 2022 through September 13, 2022.
Data featured in the ESMO poster are from preclinical
studies in mice implanted with AB12 mesothelioma cells. Following implantation, mice were given vehicle (untreated group), intravenous
(IV) cisplatin monotherapy, Allocetra monotherapy administered intraperitoneally (IP), or IV cisplatin in combination with IP Allocetra .
On day-57 post-implantation, the survival rate in
the untreated group was 0%, and the mean survival duration was 31.7 2.6 days. These were similar to the survival rate of 0% and
slightly superior mean survival duration of 36.2 5.0 days in the cisplatin monotherapy group. The survival rate and mean duration
in the Allocetra monotherapy group were 14.2%, and 40.4 10.9 days, respectively. When Allocetra was combined with
cisplatin, a synergistic anti-cancer effect was observed, as the survival rate and mean duration in the combination therapy group were
55% and 49.3 10.6 days, respectively. Notably, the increase in survival duration observed in the combination therapy group was
statistically significant compared to the untreated group (p=0.0033, log rank), cisplatin monotherapy group ( p=0.0035, log rank), and
Allocetra monotherapy (p=0.0413, log rank) group.
Also featured in the ESMO poster are preclinical mesothelioma
data showing a substantial survival benefit when Allocetra is combined with an anti-PD1 checkpoint inhibitor, and previously presented
preclinical data in mesothelioma showing a substantial survival benefit when Allocetra is combined with a commercially approved
anti-CTLA4 checkpoint inhibitor.
"Our latest data add to an extensive body of
preclinical evidence demonstrating Allocetra's potential to address unmet needs in a variety of difficult-to-treat
solid cancers," said Prof. Dror Mevorach, M.D., Chief Scientific Officer of Enlivex and co-author of the poster. "The disproportionate
presence of pro-tumor macrophages in tumor microenvironments severely limits the efficacy of many drug classes, including both immuno-
and chemotherapies. With Allocetra , we believe we can reprogram resident macrophages back to their homeostatic state, thereby enhancing
the efficacy of complementary anti-cancer agents and avoiding the accumulation of pro-tumor macrophages. The data being presented at ESMO
provide additional support for this hypothesis, as they highlight the potential benefits of combining Allocetra with cisplatin
or immune checkpoint inhibitors such as anti-PD1 or anti-CTLA4. We look forward to discussing our findings with the medical community
at this year's congress."
Oren Hershkovitz, Ph.D., Chief Executive Officer of
Enlivex, commented, "We are very pleased with the results of these preclinical studies, which support our ongoing Phase I/II trial
evaluating Allocetra plus chemotherapy in patients with peritoneal metastases. This trial has been carefully designed to clinically
demonstrate Allocetra's novel mechanism of action and further our understanding of its safety profile and anti-cancer
activity. Successfully achieving these goals would represent a key milestone, as it would bring us substantially closer to providing cancer
patients with a novel and highly scalable next-generation cell therapy."
Mesothelioma, Treatment Landscape, and Macrophage-Solid
Mesothelioma is one of the deadliest solid cancers,
with the few available treatment options having limited efficacy. These include checkpoint inhibitors targeting CTLA4 and PD1, as well
as cisplatin-based combinations. People most at risk for mesothelioma generally have had long-term exposure to asbestos (e.g., construction
workers, pipe fitters, and shipyard workers).
In mesothelioma and other solid cancers, the efficacy
of many anti-cancer agents is limited by tumor mechanisms that facilitate the recruitment of macrophages that become "pro-tumor"
tumor associated macrophages (TAMs) rather than "anti-tumor" macrophages. The TAMs typically form a physical layer on top of
the solid tumor and promote tumor growth and metastasis, thereby contributing to poor clinical outcomes and response to therapy. Allocetra
is a cell therapy in development that targets these TAMs. Allocetra's proposed mechanism of action is to change the
balance of macrophage populations so that they skew towards anti-tumor macrophages and away from pro-tumor macrophages.
The ESMO poster (#479P) is titled, "Synergistic
anti-tumor effect of Allocetra-OTS in combination with immune checkpoint inhibitors (ICI)/chemotherapy/CAR-T, through in-vivo reprogramming
of macrophages." It is currently available for viewing on ESMO's virtual platform and will also be presented by Prof. Mevorach,
during Poster Session 13 of the ESMO Congress.
ESMO is a leading professional organization for medical
oncology. Its core missions are to: (1) improve the quality of cancer care, from prevention and diagnosis all the way to palliative care
and patient follow-up; (2) educate - doctors, cancer patients and the general public - on the best practices and latest advances
in oncology; and (3) promote equal access to optimal cancer care for all patients.
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 https://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.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
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