EQS-News: What's Next For Cell Therapy In Oncology? Enlivex (NASDAQ: ENLV) Says It Has The Answers

Since Robert Hooke discovered cells in 1665 and Theodor Schwann proposed the classical cell theory in 1839, the cell therapy industry has grown by leaps and bounds.

Today, there are several potential applications of cell therapies. They can be used in treating infectious and autoimmune diseases, fighting cancers, improving a weakened immune system, helping patients with neurological disorders, rebuilding damaged cartilage in joints and repairing spinal cord injuries, among other applications.

Because of the wide applications of this technology, the global cell therapy market is growing. Governments around the world are increasingly investing in the biopharmaceutical industry's development, and the cell therapy industry is being propelled forward by an increase in the number of clinical trials for cell-based treatments.

Already, leading industry participants like Fate Therapeutics (NASDAQ: FATE), Enlivex Therapeutics Ltd. (NASDAQ: ENLV), bluebird bio Inc. (NASDAQ: BLUE) and NKarta Therapeutics Inc. (NASDAQ: NKTX) are introducing ground-breaking cell treatments into the global market.

In particular, Enlivex Therapeutics says it is already looking into the future of cell therapy in oncology.

Currently, cellular therapies are designed to improve the immune system's ability to fight cancer. Manufacturing them involves collecting a specific set of cells — T-cell transfer therapy — from the blood, modifying them to produce a more vigorous attack on a patient's cancer cells and then reinjecting them into the patient.

Apart from T-cell therapy, another area of research in cell therapy is CAR-T cell therapy.

In this treatment, T-cells are taken from a patient's blood. Then, the gene for a unique man-made receptor binds to a specific protein on the patient's cancer cells — known as a chimeric antigen receptor (CAR) — and is added to the T-cells. This alteration turns the T-cells into CAR-T cells that attack the patient's cancer cells.

In what could be a new approach, Israel-based Enlivex reports developing Allocetra™, an off-the-shelf therapy designed to reprogram macrophages into their homeostatic state.

Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These nonhomeostatic macrophages contribute significantly to the severity of such diseases.

By restoring macrophage homeostasis, Allocetra™ has the potential to provide an immunotherapeutic mechanism of action for life-threatening clinical indications – defined as unmet medical needs – as a stand-alone therapy or in combination with therapeutic agents.

Enlivex Executive Chairman Shai Novik, speaking at Cantor Fitzgerald's Cell and Genetic Medicines Conference, highlighted the company's initial focus on sepsis indication, which has a high unmet need. He said that the first solid tumor clinical trial was initiated a few months ago.

Since being founded in October 2005, the company reports its mission has been to establish new equilibriums that solve complex diseases. According to Enlivex, Allocetra™ cell-based therapy breaks old paradigms, effectively treating numerous acute conditions through a radically different clinical approach.

Novik said in an interview with The Jerusalem Post that a team of scientists, doctors, investors and entrepreneurs are working together to develop what they believe could "tackle some of the most problematic diseases, save more patients and ultimately change the world."

As a clinical-stage company focused on macrophage reprogramming, Enlivex says it intends to develop and commercialize a drug pipeline for macrophage reprogramming in solid cancers, sepsis and other indications.

The company reports that preclinical and clinical trials of Allocetra™ have been promising. The trials have started to show that restoring macrophage homeostasis could help people recover faster and with fewer complications when used on its own or in combination with other therapeutic agents.

As part of a new generation of companies representing the future of cell therapy – off-the-shelf, highly scalable and low COGS “beyond CAR-T” cell therapies – Enlivex is focused on a highly differentiated novel immunotherapeutic mechanism – macrophage homeostasis. Macrophage homeostasis is severely disrupted by certain diseases states, and such imbalance is critical to the progression of the diseases. Allocetra has the potential to introduce highly-effective, low-cost allogeneic cell therapies for life-threatening clinical indications that are defined as "unmet medical needs", including sepsis – one of the leading causes of mortality, and oncology, through restoration of macrophage homeostasis. Enlivex is led by a seasoned management team who founded PROLOR Biotech and led it to a successful $560 financial exit and a partnership with Pfizer. PROLOR’s lead product, now named NGenla® by Pfizer, recently received marketing approval in Australia, Canada, Japan and the EU.

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.

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Shachar Shlosberger

shachar@enlivexpharm.com

https://enlivex.com