Will Another Enlivex Innovation Break The Glass Ceiling For Solid Tumor Treatments?

Cell therapy — the use of stem cells and various engineered immune cells to target difficult-to-treat diseases like cancer and autoimmune conditions — has arguably been one of the big breakthroughs in modern medicine. By tapping into the natural functions of the body’s own cells and then supercharging them with genetic engineering, researchers have been able to develop a slew of powerful treatments.

As the potential for cell reprogramming may continue to grow, so too does the market. Already valued at $7.8 billion in 2020, the global cell therapy market is expected to exceed $23 billion by 2028. Driving part of that growth is a competitive landscape of pharmaceutical companies exploring solutions to make the innovative treatments easier to manufacture at scale and more affordable for the patients who need them.

One of the relatively unknown companies is Enlivex Therapeutics Ltd. ENLV, a clinical-stage immunotherapy company that says it is developing a highly differentiated cell therapy for the treatment of cancer, which may break the glass ceiling of cancer therapy and offer, for the first time ever, life-saving therapy for patients without any hope today. 

First Generation Cell Therapies Held Promise But Struggle To Break Through Bottleneck?

First-generation cell therapies focused on autologous treatments —  cells were taken from the patient who will receive the treatment.

These custom-engineered, made-to-order cell therapies have sometimes worked wonders, but manufacturing them is slow, expensive, and not easy to scale. This has rendered the potent therapies too expensive for many patients. 

To change that, some companies have begun exploring the possibility of allogeneic cell therapies — treatments that use healthy donor cells from a different person than the patient who will receive the treatment.

By using donor cells, pharmaceutical companies could potentially produce larger batches, offering the power of genetically engineered cell therapies but in a universal formula that doesn’t have to be custom-produced for each patient.

Universal, off-the-shelf cell therapies like these could be easier to manufacture at scale, making them more affordable to more patients. But low cost and high manufacturing scalability are not enough. Engineered T-cells that were successful against blood cancers failed in solid cancers. To combat this problem, several companies started to develop cell therapies that target other immune cells, not T-cells. 

Fate Therapeutics Inc. FATE, for example, says it is engineering natural killer (NK) cells. The company’s pipeline of allogeneic NK cell therapy candidates is meant to leverage the disease-fighting capabilities of each of these cells for the treatment of a range of cancers and other diseases.

NKarta NKTX claims its “proprietary technology is designed to harness the power of these important pathogen-fighting immune cells and is uniquely capable of enhancing their ability to search and destroy tumor cells.”

Rubius Therapeutics Inc. RUBY states it is developing universal, off-the-shelf treatments based on engineering of red blood cells. The company’s Red Cell Therapeutics takes healthy donor CD34+ cells and genetically engineers them into targeted cellular medicines for various cancers and autoimmune diseases.

Enlivex Reports Making Allogeneic Therapies To Rebalance Immune Cells Named Macrophages, A Highly Differentiated Oncology Cell Therapy Approach

Enlivex’s reported focus on macrophage cells puts it among the handful of cell therapy companies — alongside Fate, NKarta and Rubius — that have started to expand the scope beyond engineered T cells.

Macrophage cells are a specialized type of cells that detect and destroy bacteria and other harmful pathogens in the body, as well as orchestrate anti-cancer immune activities. When they detect an invader, they immediately engulf it and destroy it, and if needed they recruit the rest of the immune system to join the fight. This powerful capability can make them a powerful ally in the treatment of many diseases.

However, in many solid tumors, the tumor cells – as part of their defense mechanism – negatively reprogram macrophages in the tumor microenvironment (TME), such that they form a protective layer on top of the solid tumor and produce immunosuppressive signals, making it very difficult for anti-cancer immune cells or anti-cancer drugs to penetrate and destroy the tumor cells.  

Enlivex says its Allocetra therapy can reprogram these pro-tumor macrophages back to their normal, anti-cancer state, thereby allowing immune cells and anti-cancer drugs to reach significantly higher effectiveness in killing tumor cells.  What makes Allocetra different from the other approaches is the focus on Macrophages. Allocetra is focusing on removing cancer defenses instead of enhancing an attacking therapy.

Allocetra is made by obtaining certain immune cells from healthy donors which are then modified so they’ll be devoured by the patient’s own macrophages.  The high doses of devoured Allocetra cells lead to macrophage satiety, which triggers their reboot and return to a normal state.  

Enlivex recently published highly encouraging data from various studies it conducted that exemplify the potential of this therapeutic strategy. In an ovarian cancer study conducted in collaboration with Yale Cancer Center, up to 50% of the mice survived compared to 0% from the untreated group. In another mesothelioma cancer study, up to 100% of the mice survived compared with 0% survival for the untreated group. Enlivex announced that it has obtained regulatory approval to initiate its first ever human clinical trial in advanced solid tumor patients, that will be treated by a combination of Allocetra and chemotherapy, and that a second study will initiate later this year.

With these clinical trials expected to initiate shortly, the company states that it hopes to offer a scalable, affordable, off-the-shelf macrophage reprogramming cell therapy for these difficult-to-treat patients as soon as possible. 

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