A clinical study led by renowned Dr. Gal Markel, that “modifies” the patient’s body to respond to immunotherapy, as a treatment for metastatic disease.

Revolutionary Trial Transforms the Patient’s Body to Better Respond to Immunotherapy

Sheba professor designs and leads a breakthrough human clinical study that “modifies” the patient’s body to respond to immunotherapy, as a treatment for metastatic disease.

For the first time, a human clinical trial was launched to investigate a way to transform a patient’s body so that it could respond to immunotherapy more effectively. This method of reversed personalized medicine works by neutralizing cancer’s ability to block the patient’s natural immune system responses, thereby extending or saving their life.

Prof. Gal Markel, Director of the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center, formulated and headed the 40-patient study, which will treat resistant metastatic melanoma, triple-negative breast cancer, renal cell carcinoma, and non-small cell lung cancer patients.

The study, which is expected to take two and a half years, is being conducted with the use of technology developed by Immunicom of San Diego. Immunicom’s LW-02 plasma filtration was approved by the FDA as a “breakthrough” system.

“Immunicom’s novel methodology represents a total change from traditional standards-of-care and offers the potential for achieving much better clinical outcomes with fewer treatment side effects,” Markel said in an interview with the Jerusalem Post.

For the past three years, Markel’s team at Sheba has been working on a drug concept that they termed “reversed personalized medicine.”

In a personalized treatment approach, the patient’s gene or characteristic is first identified. Then, scientists match the right protocol or drug to the patient, or develop a customized solution. Immunotherapy, which harnesses the power of the natural immune system, is regarded as the premier tool for personalized medicine in the fight against cancer.

Nowadays, there are numerous drugs that can be used for immunotherapy. However, these drugs are only effective in about a third of patients, while the remaining two-thirds are usually left with minimal treatment options. That’s where Markel’s research enters the field with the initiative to try a novel approach. Instead of matching the drug to the patient, the new method modifies the patient to work better with the immunotherapy drug.

Cancer cells are able to hide from the body’s immune system by secreting decoy proteins or receptors. These proteins enter the patient’s bloodstream, blocking the immune system’s ability to fight the cancer. Therefore, even if existing immunotherapy drugs are delivered to the patient, they cannot attack at full capacity.

“The only way to neutralize these proteins is to get rid of them or filter them out of the bloodstream, which would eliminate their effect and then the immune system can exude its anti-cancer effect and can be harnessed with existing drugs,” Markel explained.

Eliminating or filtering out the proteins is the basis of reversed personalized medicine, and Immunicom’s LW-02 plasma filtration system accomplishes this goal through immunophoresis. The system is a disposable device that’s coated with a highly selective compound that only attaches to the decoy receptors. When plasma is run through the device, it emerges without the decoy receptors. (In effect, the immunophoresis process is similar to dialysis, which draws the patient’s blood outside the body and only returns it to the patient after filtering out the toxins.)

Markel explains that by repeating the immunophoresis process enough times, the suppressive receptors in the blood should be reduced enough to enable the cancer therapies to work effectively. While the existence of these proteins was discovered back in the 1990s, this is the first time anyone has managed to get rid of them.

“The most important thing for me is to improve cancer patients’ survival and quality of life,” Markel said. “We want to do what is good for patients … With this trial, there is real hope that we can really make that happen.”

The trial is funded by Immunicom, with the support of a grant by the Samueli Foundation. Hagit Harati, head nurse and co-founder of Sheba’s Immunophoresis Unit, will be in charge of executing the clinical trial.