Monkeypox Could Reportedly Trigger An Uptick In Sepsis Cases But This Israeli Biotech Company Says It May Have Found A Treatment

As the mysterious monkeypox outbreak has many scientists on heightened alert, the rare virus could pose an additional threat to a global population still reeling from the COVID-19 pandemic. 

Researchers are still trying to understand the long-term effects that COVID may have on a person’s immune system, and another infectious outbreak could put those who are now more vulnerable to disease at risk of severe complications.

This has sparked a renewed interest in finding treatments for the complications that can arise from an infection that spreads faster than the immune system can fight. Enlivex Therapeutics Ltd. ENLV, a clinical-stage pharmaceutical company with a goal of developing affordable, off-the-shelf cell therapies, says it hopes to address that problem with its leading drug candidate, Allocetra.

Scientists Still Aren’t Sure What’s Driving The Recent Monkeypox Outbreak

Twelve countries around the globe have collectively reported over 120 confirmed or suspected cases of monkeypox in recent months. The number is still small, but the outbreak is so sudden and unexpected that researchers are scrambling to identify the source and curb the spread before it becomes more widespread.

The concern stems from the fact that the outbreak seems confined to Europe and North America, where monkeypox is not typically found, and none of the reported cases have traveled to countries where the virus is endemic or had any known contact with infected animals. 

This has some scientists worried that an infection once thought to only spread through contact with an infected wound or contaminated surface may be spreading silently and undetected via other means. 

Meanwhile, for doctors on the frontlines, treatment options are limited because of how rare the virus is. They typically rely on the off-label use of antivirals not originally intended for monkeypox, like SIGA Technologies Inc.’s SIGA TPOXX or Gilead Sciences Inc.’s GILD Vistide.

A New Outbreak May Put Vulnerable Populations At Risk of Sepsis And Organ Failure

While the infection can resolve on its own, children and people with compromised immune systems are at risk of severe complications like sepsis. Each year, approximately 1.7 million adults in the United States develop sepsis. Of those, about 270,000 will die from the complication — accounting for as much as a third of deaths inside hospitals.

In any immune response, the process of killing harmful cells can harm a few healthy cells along the way. That’s why the inflammation that helps kill infections can also cause pain and other discomforts to the patient, too. 

Sepsis is what happens when that immune response is so strong that the collateral damage of fighting the infection is so extreme that it’s life-threatening. Instead of a little swelling or a fever, sepsis can cause entire organs to shut down and even lead to death. 

Options for septic patients are limited, and there is still no approved treatment specifically for sepsis. All doctors can do is try to fight the infection that’s causing the septic response and protect the patient’s organs from damage as best they can. 

That typically means putting a patient on a course of antibiotics while keeping them on intravenous fluids and, if their blood pressure remains too low, vasopressors like Levophed, a norepinephrine-based medicine manufactured by Pfizer Inc. PFE subsidiary Hospira. In extreme cases, doctors may use kidney dialysis or opt to surgically remove infected tissue in hopes of slowing its spread and making it easier to fight. 

Enlivex Reports That Its Off-the-Shelf Cell Therapy Could Become A Weapon Against Sepsis

Enlivex’s macrophage-based approach could help become the world’s first sepsis treatment. Macrophage cells are the lesser-known allies of T cells, the snipers of the immune system that target and destroy foreign substances in the body. 

Once a pathogen is detected, the monocyte turns itself into the best macrophage to fight the current infection. It then “eats” the pathogen, rips it apart and exposes the proteins and molecules to T cells, making it easier for the T cells to recognize that an infection exists. 

But with sepsis, those macrophages can become imbalanced, which may lead to an overproduction of inflammatory factors causing the damage associated with the condition. 

Enlivex states that it is developing a cell therapy that could restore balance to the patient’s macrophage in hopes of modulating the inflammatory response to prevent organ failure and damage. 

Allocetra, the clinical-stage pharmaceutical’s leading drug candidate, does this by taking healthy donor cells and modifying them to express one of the eat-me signals macrophages look for. Once treated, the patient’s own macrophages detect that eat-me signal and engulf the modified macrophages. 

The imbalanced macrophages, once having engulfed large quantities of Allocetra, become balanced, and guide the immune system into its normal state, preventing deterioration into organ dysfunctions and failures.  

In a Phase 1b trial of Allocetra as a treatment for sepsis-related organ failure, subjects with sepsis, each of which had between 2-5 dysfunctioned organs, were treated with Allocetratherapy and exhibited restored organ function and a faster recovery. While patients with comparable levels of sepsis historically had a mortality rate of about 27%, and an additional 33% still had organ failures after 28 days from the occurrence of sepsis, 100% of the patients treated with Allocetra had complete recovery of their respective organ failures and were released from the hospital.

These early results spurred a Phase 2 study that began last year. Interim data from that study is expected at the beginning of 2023. In the case the Phase 2 study’s results resemble those observed in the Phase 1, Allocetra would be well on its way to change the lives of patients with sepsis, a potential $33 billion target market for Enlivex.

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