Enlivex Receives Israeli Ministry of Health Approval for the Initiation of a Phase I/II Trial Evaluating Allocetra Alone and in Combination with a PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumors Trial bui

Enlivex Receives Israeli Ministry of Health

Approval for the Initiation of a Phase I/II Trial Evaluating Allocetra Alone and in Combination with a PD1 Checkpoint Inhibitor

in Patients with Advanced Solid Tumors

- Trial builds on encouraging preclinical studies conducted in

collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra was

combined with PD1 checkpoint inhibition in a murine model of ovarian cancer

Nes-Ziona, Israel, Aug. 16, 2022 (GLOBE NEWSWIRE)

-- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company,

today announced that the Israeli Ministry of Health (MOH) authorized the initiation of a company-sponsored Phase I/II clinical trial

designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra alone, and in combination with a PD1 checkpoint

inhibitor, in patients with advanced solid tumors.

Einat Galamidi, M.D., Vice President, Medical

of Enlivex, stated, "With Allocetra treatment, we aim to change the balance of macrophage populations surrounding the solid

tumor environment in favor of anti-cancer activity in order to overcome the biological mechanisms underlying checkpoint inhibitor resistance.

Collaborative studies with Yale Cancer Center have generated meaningful preclinical data, suggesting we may be successful in these efforts,

with Allocetra and an anti-PD1 agent synergistically combining, which delivered a statistically significant survival benefit in

a murine model of ovarian cancer. We aim to build on these results in our upcoming Phase I/II trial and are pleased that the Israeli

Ministry of Health has cleared it for initiation."

The planned 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. Patients in Stage 2 will receive three injections of Allocetra concomitantly with the studied anti-PD1

agent. The primary objective of the study is to evaluate safety and tolerability throughout the treatment period and through one week

after the last administration of Allocetra . Key secondary endpoints include efficacy assessments, such as best overall response

rate, progression-free survival, and overall survival. Changes in immune cell/cytokine profiling in peritoneal fluid will also be

assessed as an exploratory endpoint.

The planned study population will be adult

patients with advanced, unresectable or metastatic solid tumors that have relapsed or have been refractory to available approved therapies,

or patients who are not eligible for, or have declined additional standard-of-care systemic therapy.

Though commercially successful, checkpoint

inhibitors have limited efficacy in many cancers, with a 2019 study estimating less than 13% of all U.S. cancer patients responded to

these therapies1. This limited efficacy of checkpoint inhibitors in certain solid cancers is linked to tumor mechanisms that

facilitate the recruitment of macrophages which become "pro-tumor" tumor associated macrophages (TAMs). The TAMs typically

form a physical layer on top of the solid tumor and induce immunosuppression in the solid tumor microenvironment. This hampers the ability

of immune cells, which are the effectors of checkpoint inhibitor therapy, to efficiently attack the tumor cells. Moreover, TAMs promote

tumor growth and metastasis through various additional mechanisms that contribute to poor clinical outcomes and response to therapy.

Previously reported preclinical data from solid tumor models suggest that Allocetra has the potential to reprogram pro-tumor macrophages

back to their homeostatic state and may thereby promote disease resolution and enhance the efficacy of checkpoint inhibitors and other

immunotherapeutic agents.

1. Haslam A, Prasad V. Estimation

of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Netw Open.

2019 May 3;2(5):e192535. doi: 10.1001/jamanetworkopen.2019.2535. PMID: 31050774; PMCID: PMC6503493.

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 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.

Shachar Shlosberger, CFO

Enlivex Therapeutics, Ltd.

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