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EnlivexTherapeutics Ltd. (NASDAQ: ENLV) announced that Israel, Spain andGreece have cleared amendments to the company’s Phase II trialprotocol that will allow the study to enroll more patients.
The cleared amendmentsalso allow Enlivex to use a newly developed frozen formulation ofAllocetraTM — the macrophage reprogramming immunotherapy it’sevaluating as a potential sepsis treatment in the clinical trial.
The Current Standard Of Care ForSepsis Needs Improvement
Each year, about 1.7million U.S. adults develop sepsis in response to aninfection. Of those, about 350,000 will die from septic shock,according to the Centers for Disease Control (CDC). Despite the risksof sepsis, there is currently no specific treatment for thelife-threatening condition.
That’s because it’s not a pathogen in its ownright but an extreme response to an infection the patient already has.That underlying infection can be bacterial, fungal or viral sotreating sepsis often starts with identifying the underlying infectionand administering the appropriate antibiotic, antimicrobial orantiviral treatment.
This initial treatment, along with intravenous fluids andvasopressors to maintain organ function and blood pressure, forms thecurrent standard of care, but they’re really just a way of keepingthe patient alive while their immune system, hopefully, fights theinfection causing the sepsis response.
Even with this standard of care, timing iseverything. In a study of New York State Department of Health data,researchers found that for each hour antibiotic treatment was delayedin patients with sepsis, the risk of mortality increased by 4% .In other words, patients need to receive treatment as soon as possibleto increase the odds of survival.
This large unmet need has motivated manypharmaceutical companies to explore new treatment options, but so far,few have shown significant promise. For example, monoclonal antibodies(mAbs), like Merck & Co. Inc. ’s (NYSE: MRK) bezlotoxumabor Aridis Pharmaceuticals Inc. ’s (NASDAQ: ARDS) tosatoxumab,have made some headway, but these are engineered to target specificinfections. So doctors would need to identify the specific mAb to useand hope that one exists for that particular infection, which is not aguarantee since mAbs are still relatively new.
Enlivex’s Allocetra Is An ImmunotherapyThat Could Rebalance The Immune Response
At its core, sepsis is an extreme immuneresponse to an infection in the body. That’s why Enlivex has chosento explore immunotherapy options for treating the condition.AllocetraTM, it’s leading drug candidate, works by reprogrammingmacrophages from healthy donor cells to help the patient’s ownmacrophages return to their homeostatic state of stability.
Macrophages are a typeof immune cell that circulates throughout the body, monitoring forsigns of infection. When a pathogen is spotted, they immediately“eat” it and send out an alarm signal to the rest of the immunesystem. Certain conditions, like sepsis, can disrupt macrophages,triggering an excessive inflammatory response that can end up causingthe organ damage and organ failure that make sepsis solife-threatening.
Allocetra’s formula uses donor macrophages that have beenprogrammed to send out an “eat me” signal to the host’smacrophages. Once engulfed, the donor cells then reprogram those hostmacrophages to return to their homeostatic state.
In the preclinical andclinical trials Enlivex has completed so far, that return tohomeostasis has resulted in reduced mortality and improved sequentialorgan failure assessment (SOFA) scores, suggesting that theimmunotherapy could help moderate the immune response and protectorgans from damage and failure.
While antimicrobials will still be necessary forfighting the underlying infection, Allocetra’s ability to influencethe host’s overactive immune response could become an essential toolfor preventing long-term damage and reducing mortality rates.
The Phase II Clinical Trial Will Include AnExpanded Patient Population And A More Shelf-Stable Version OfAllocetra
Initially, the Phase II trial was limited to patients withpneumonia-associated sepsis. With the recent amendments cleared byIsrael, Spain and Greece, Enlivex is now able to expand the trial toinclude patients with sepsis related to biliary, urinary tract andperitoneal infections.
The amendments also clear the way for the clinical-stageimmunotherapy company to treat patients in the trial with its newerfrozen formulation of Allocetra. In development for the last twoyears, frozen Allocetra is expected to have a shelf life spanningyears rather than the 96-hour shelf life of the liquid version. Alonger shelf life means Enlivex can manufacture the novelimmunotherapy at scale and hospitals can keep it in stock so thatit’s readily available for rapid deployment for the treatment ofsepsis patients.
Enlivex plans to submit these same protocol amendments in otherjurisdictions in hopes of further expanding its Phase II research. Butwith the regulatory clearance achieved so far, the company isoptimistic that it can shorten the timeline to potential approval offrozen Allocetra as a sepsis treatment, which could move up the dateof a possible commercial launch.
As part of a new generationof companies representing the future of cell therapy –off-the-shelf, highly scalable and low COGS “beyond CAR-T” celltherapies – Enlivex is focused on a highly differentiated novelimmunotherapeutic mechanism – macrophage homeostasis. Macrophagehomeostasis is severely disrupted by certain diseases states, and suchimbalance is critical to the progression of the diseases. Allocetrahas the potential to introduce highly-effective, low-cost allogeneiccell therapies for life-threatening clinical indications that aredefined as "unmet medical needs", including sepsis – one ofthe leading causes of mortality, and oncology, through restoration ofmacrophage homeostasis. Enlivex is led by a seasoned management teamwho founded PROLOR Biotech and led it to a successful $560 financialexit and a partnership with Pfizer. PROLOR’s lead product, now namedNGenla® by Pfizer, recently received marketing approval in Australia,Canada, Japan and the EU.
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Safe HarborStatement: 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 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, ALLOCETRA TM programs. All suchforward-looking statements are made pursuant to the safe harborprovisions of the Private Securities Litigation Reform Act of 1995.Investors are cautioned that forward-looking statements involve risksand uncertainties 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 ALLOCETRA TM product line could also be affected by anumber of other factors, including unexpected safety, efficacy ormanufacturing issues, additional time requirements for data analysesand decision making, the impact of pharmaceutical industry regulation,the impact of competitive products and pricing and the impact ofpatents and other proprietary rights held by competitors and otherthird 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 withthe Securities and Exchange Commission, including in the Company’smost recent Annual Report on Form 20-F filed with the Securities andExchange Commission. The forward-looking statements contained in thispress release speak only as of the date the statements were made, andwe do not undertake any obligation to update forward-lookingstatements, except as required under applicablelaw.
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