Enlivex Receives Allocetra IND Clearance From The U.S. Food And Drug Administration For Treatment Of Patients with Advanced Solid Malignancies

Rhea-AI Summary

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced that the FDA approved its Investigational New Drug (IND) application to study its cell therapy, Allocetra™, in patients with advanced solid tumors. This IND clearance follows positive preclinical studies in collaboration with Yale Cancer Center, showing significant survival benefits in murine models. The Phase I/II clinical trial aims to evaluate Allocetra™ alone and in combination with PD1 checkpoint inhibitors for patients with relapsed or refractory malignancies. This regulatory clearance marks a pivotal milestone in Enlivex's development trajectory.

Positive

• FDA approval of IND for Allocetra™ represents a significant milestone for Enlivex.
• Encouraging preclinical studies demonstrated substantial survival benefits in murine models.

Negative

• None.

• IND filing followed encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra™ was combined with a PD1 checkpoint inhibitor in a murine model of ovarian cancer, and additional models that demonstrated statistically significant survival benefit when Allocetra™ was combined with a PD1 or CTLA-4 checkpoint inhibitor in a murine model of peritoneal mesothelioma
  
  
• The protocol of the IND includes intravenous administration of frozen-formulation Allocetra™, stand-alone, and in combination with a PD1 checkpoint inhibitor, to a study population that encompasses 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 

Nes-Ziona, Israel, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study Allocetra™ in patients with advanced solid malignancies. The FDA’s Phase I/II clearance follows a recent announcement by the Company that the first patient has been dosed in a Phase I/II multi-center clinical trial in Israel designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra™ stand-alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.

Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, stated "We are pleased with the FDA’s regulatory clearance for our IND. The formal initiation of clinical development of Allocetra^TM for oncology indications in the United States represents a significant milestone for Enlivex. We believe that Allocetra^TM has the potential to provide a paradigm shift in the treatment of advanced solid tumors, and we look forward to observing safety and potential indication of effect in patients, who we expect to enroll in several open-label Company-sponsored and investigator-initiated oncology trials during 2023.”

ABOUT ALLOCETRA™

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 ENLIVEX

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, ALLOCETRA^TM 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 ALLOCETRA^TM 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.

ENLIVEX CONTACT
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACT
Eric Ribner
LifeSci Advisors
eric@lifesciadvisors.com

FAQ

What is the recent FDA approval related to ENLV?

The FDA approved Enlivex Therapeutics' IND application for Allocetra™, allowing studies in patients with advanced solid tumors.

What were the findings of the preclinical studies for Allocetra™?

Preclinical studies showed significant survival benefits when Allocetra™ was used with PD1 checkpoint inhibitors.

What is the purpose of the Phase I/II trial for Allocetra™?

The Phase I/II trial aims to evaluate the safety, tolerability, and preliminary efficacy of Allocetra™ in advanced solid tumors.

How does Allocetra™ work in treating cancers?

Allocetra™ is designed to reprogram macrophages to restore their homeostatic state, potentially improving cancer treatment outcomes.

What patient population is targeted in the Allocetra™ study?

The study targets adult patients with advanced, unresectable or metastatic solid tumors that are relapsed or refractory to standard therapies.