Ministry health

Enlivex Therapeutics Receives Approval from the Israeli Ministry of Health to Initiate a Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients With Peritoneal Metastases Resulting from Solid Cancers – Form 6-K

Enlivex receives authorization from the Israeli Ministry of Health to launch a phase I/II trial evaluating Allocetra combined with chemotherapy in patients with peritoneal metastases resulting from solid cancers

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The trial will be the first clinical study of Allocetra™ in cancer patients, following encouraging preclinical data presented at the 2022 International Society for Gene and Cell Therapy conference, and preclinical data in prostate cancer. ovary presented at the 2022 American Society of Clinical Oncology Conference

Nes-Ziona, Israel, June 6, 2022 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the Israeli Ministry of Health (MOH) had authorized the initiation of a company-sponsored Phase I/II clinical trial evaluating Allocetra™ plus chemotherapy in patients with peritoneal metastases resulting from solid cancer.

Peritoneal cancer, whether it arises 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 new treatment options, as standard chemotherapy (SOC) provides only modest survival benefits. The median survival of patients with peritoneal metastases differs depending on the location of the primary tumor, but is often low, with survival rates of 2.9 months, 6.5 months and 6.9 months reported for cancers of pancreatic, gastric and colorectal origin, respectively.

The planned Phase I/II trial is an 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 assess the safety and potential preliminary efficacy of Allocetra™ combined with SOC chemotherapy in patients with peritoneal metastases resulting from solid cancer. The study will begin with two intra-patient and intra-cohort dose escalation cohorts to determine the maximum achievable dose (MFD) of Allocetra™ in this population, followed by two additional cohorts comparing the administration of Allocetra™ to the selected dose before or after administration of SOC via a pressurized intraperitoneal aerosol (PIPAC) chemotherapy procedure; a technique applied when patients are not eligible to receive standard therapy due to considerable tumor burden, or large amounts persistent ascites and other circumstances).

Allocetra™ and SOC chemotherapy administered intraperitoneally administered via PIPAC will be administered to patients every six weeks. Systemic chemotherapy will also be administered according to the plan of the treating oncologist. The primary endpoint is the number and severity of Allocetra-related adverse events and serious adverse events during the 16-week period 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 tissue will also be assessed as an exploratory endpoint.

Currently, the efficacy of many anticancer agents is hampered by the body’s tumor defense mechanisms that facilitate the recruitment of macrophages that become “pro-tumor” tumor-associated macrophages (TAMs) rather than “anti-tumor” macrophages. “. TAMs typically form a physical layer above the solid tumor and induce immunosuppression in the solid tumor microenvironment. This in turn promotes tumor growth and metastasis and contributes to poor clinical outcomes and poor response to treatment. Previously reported preclinical data from solid tumor models suggests that Allocetra™ has the potential to reprogram pro-tumor macrophages to their homeostatic state and thus may promote disease resolution and provide patients who do not respond well to therapies existing FDA-approved effective treatment option.

Einat Galamidi, MD, Vice President Medical of Enlivex, said, “Receiving this clearance from the MOH is an important step toward expanding Allocetra’s potential therapeutic impact in oncology. Our preclinical studies suggest that Allocetra™ may improve the efficacy of a wide range of agent treatments by weakening tumor defense mechanisms through a novel mechanism of action that pushes macrophage populations into a more anti-cancer state. We look forward to begin clinical evaluation of this hypothesis with both this chemotherapy combination study and another planned solid tumor study evaluating Allocetra™ combined with a checkpoint inhibitor.”

Enlivex plans to initiate the Phase I/II trial evaluating Allocetra™ in combination with chemotherapy in patients with peritoneal metastases resulting from solid cancer in the third quarter of 2022. The Company also plans to initiate a Phase I/ II evaluating Allocetra™ in combination with a checkpoint inhibitor at the end of 2022.

ABOUT ALLOCETRAMT

Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages to 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 new immunotherapeutic mechanism of action for life-threatening clinical indications defined as “unmet medical needs”, either as a stand-alone therapy or in combination with therapeutic agents leading.

ABOUT ENLIVEX

Enlivex is a clinical-stage macrophage reprogramming immunotherapy company developing Allocetra™, a ready-to-use universal cell therapy designed to reprogram macrophages to their homeostatic state. Resetting non-homeostatic macrophages to their homeostatic state is essential for rebalancing the immune system and resolving life-threatening conditions. For more information, visit https://enlivex.com/.

Safe Harbor Statement: This press release contains forward-looking statements, which can 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 clinical studies and preclinical experiments, effectiveness and market opportunities for ALLOCETRAMT 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 could affect Enlivex’s business and prospects, including risks that Enlivex may fail to generate revenue or develop commercial products; that products in development may fail, fail to achieve expected results or efficacy, and/or fail to generate data to support approval or commercialization of such products for the indications under study or for other indications; that ongoing studies may not continue to show substantial activity or no activity; and other risks and uncertainties that could cause actual 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 materially from the results of clinical and other trials in animals. Results of early-stage trials may differ significantly from results of more advanced and later-stage trials. The development of any product using ALLOCETRAMT the product mix could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional delays in data analysis and decision-making, the impact pharmaceutical industry regulations, 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 economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including the most recent annual report of the company on Form 20-F filed with the Security and Exchanges Commission. The forward-looking statements contained in this press release speak only as of the date on which they were made, and we assume no obligation to update any forward-looking statements except as required by applicable law.

ENLIVEX CONTACT
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
[email protected]

INVESTOR RELATIONS CONTACT

Eric Ribner

LifeSci Advisors

[email protected]