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Since Robert Hookediscovered cells in 1665 and Theodor Schwann proposed the classicalcell theory in 1839, the cell therapy industry has grown by leaps andbounds.
Today,there are several potential applications of cell therapies. They canbe used in treating infectious and autoimmune diseases, fightingcancers, improving a weakened immune system, helping patients withneurological disorders, rebuilding damaged cartilage in joints andrepairing spinal cord injuries, among other applications.
Because of the wideapplications of this technology, the global cell therapy market isgrowing. Governments around the world are increasingly investing inthe biopharmaceutical industry's development, and the cell therapyindustry is being propelled forward by an increase in the number of clinical trials for cell-basedtreatments.
Already, leading industry participants like FateTherapeutics (NASDAQ: FATE), Enlivex Therapeutics Ltd. (NASDAQ: ENLV), bluebird bio Inc. (NASDAQ: BLUE) and NKartaTherapeutics Inc. (NASDAQ: NKTX) are introducing ground-breakingcell treatments into the global market.
What's Next ForCell Therapy In Oncology?
In particular, Enlivex Therapeutics says it isalready looking into the future of cell therapy in oncology.
Currently, cellulartherapies are designed to improve the immune system's ability tofight cancer. Manufacturing them involves collecting a specific set ofcells — T-celltransfer therapy — from the blood, modifying them to producea more vigorous attack on a patient's cancer cells and thenreinjecting them into the patient.
Apart from T-cell therapy, another area of researchin cell therapy is CAR-T cell therapy.
In this treatment, T-cells are taken from apatient's blood. Then, the gene for a unique man-made receptorbinds to a specific protein on the patient's cancer cells —known as a chimeric antigen receptor (CAR) — and is added to theT-cells. This alteration turns the T-cells into CAR-T cells thatattack the patient's cancer cells.
In what could be a new approach, Israel-basedEnlivex reports developing Allocetra™, an off-the-shelf therapydesigned to reprogram macrophages into their homeostatic state.
Diseases such as solidcancers, sepsis, COVID-19 and many others reprogram macrophages out oftheir homeostatic state. These nonhomeostatic macrophages contributesignificantly to the severity of such diseases.
By restoring macrophagehomeostasis, Allocetra™ has the potential to provide animmunotherapeutic mechanism of action for life-threatening clinicalindications – defined as unmet medical needs – as a stand-alonetherapy or in combination with therapeuticagents.
Equilibriums That Solve Complex Diseases
Enlivex ExecutiveChairman Shai Novik, speaking at Cantor Fitzgerald's Cell andGenetic Medicines Conference, highlighted the company's initialfocus on sepsis indication, which has a high unmet need. He said thatthe first solid tumor clinical trial was initiated a few monthsago.
Since beingfounded in October 2005, the company reports its mission has been toestablish new equilibriums that solve complex diseases. According toEnlivex, Allocetra™ cell-based therapy breaks old paradigms,effectively treating numerous acute conditions through a radicallydifferent clinical approach.
Novik said in an interview with TheJerusalem Post that a team of scientists, doctors, investorsand entrepreneurs are working together to develop what they believecould "tackle some of the most problematic diseases, save morepatients and ultimately change the world."
PreclinicalAnd Clinical Trials Of Allocetra™
As a clinical-stage company focused onmacrophage reprogramming, Enlivex says it intends to develop andcommercialize a drug pipeline for macrophage reprogramming in solidcancers, sepsis and other indications.
The company reports that preclinical andclinical trials of Allocetra™ have been promising. The trials havestarted to show that restoring macrophage homeostasis could helppeople recover faster and with fewer complications when used on itsown or in combination with other therapeutic agents.
As partof a new generation of companies representing the future of celltherapy – off-the-shelf, highly scalable and low COGS “beyondCAR-T” cell therapies – Enlivex is focused on a highlydifferentiated novel immunotherapeutic mechanism – macrophagehomeostasis. Macrophage homeostasis is severely disrupted by certaindiseases states, and such imbalance is critical to the progression ofthe diseases. Allocetra has the potential to introducehighly-effective, low-cost allogeneic cell therapies forlife-threatening clinical indications that are defined as "unmetmedical needs", including sepsis – one of the leading causes ofmortality, and oncology, through restoration of macrophagehomeostasis. Enlivex is led by a seasoned management team who foundedPROLOR Biotech and led it to a successful $560 financial exit and apartnership 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 pressrelease contains forward-looking statements, which may be identifiedby words such as “expects,” “plans,” “projects,”“will,” “may,” “anticipates,” “believes,”“should,” “would”, “could,” “intends,”“estimates,” “suggests,” “has the potential to” and otherwords of similar meaning, including statements regarding expected cashbalances, market opportunities for the results of current clinicalstudies and preclinical experiments, the effectiveness of, and marketopportunities for, ALLOCETRATM programs. All such forward-lookingstatements are made pursuant to the safe harbor provisions of thePrivate Securities Litigation Reform Act of 1995. Investors arecautioned that forward-looking statements involve risks anduncertainties that may affect Enlivex’s business and prospects,including the risks that Enlivex may not succeed in generating anyrevenues or developing any commercial products; that the products indevelopment may fail, may not achieve the expected results oreffectiveness and/or may not generate data that would support theapproval or marketing of these products for the indications beingstudied or for other indications; that ongoing studies may notcontinue to show substantial or any activity; and other risks anduncertainties that may cause results to differ materially from thoseset forth in the forward-looking statements. The results of clinicaltrials in humans may produce results that differ significantly fromthe results of clinical and other trials in animals. The results ofearly-stage trials may differ significantly from the results of moredeveloped, later-stage trials. The development of any products usingthe ALLOCETRATM product line could also be affected by a number ofother factors, including unexpected safety, efficacy or manufacturingissues, additional time requirements for data analyses and decisionmaking, the impact of pharmaceutical industry regulation, the impactof competitive products and pricing and the impact of patents andother proprietary rights held by competitors and other third parties.In addition to the risk factors described above, investors shouldconsider the economic, competitive, governmental, technological andother factors discussed in Enlivex’s filings with the Securities andExchange Commission, including in the Company’s most recent AnnualReport on Form 20-F filed with the Securities and Exchange Commission.The forward-looking statements contained in this press release speakonly as of the date the statements were made, and we do not undertakeany obligation to update forward-looking statements, except asrequired under applicable law.
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