Sheba initiates ‘reversed personalized’ cancer trial
Patients will be ‘modified’ to better respond to immunotherapy drugs
A first-ever human clinical trial could extend or even save patients’ lives by neutralizing cancer’s ability to block a patient’s natural immune defense mechanisms, which are usually exhausted when the patient is suffering from metastatic disease.
The 40-patient clinical study conceived and led by Prof. Gal Markel, director of the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center, will treat resistant metastatic melanoma, triple-negative breast cancer, renal cell carcinoma and non-small cell lung cancer patients using Immunicom’s LW-02 plasma filtration.
“Immunicom’s novel methodology represents a sea change from traditional standards-of-care and offers the potential for achieving much better clinical outcomes with fewer treatment side effects,” Markel told The Jerusalem Post.
He said that for the past three years, his team at Sheba Medical Center has been working on a drug concept they call “reversed personalized medicine.”
“With personalized medicine, we identify the patient’s gene or characteristic and then we match the right protocol or drug or develop something personal to the patient,” Markel explained. “Immunotherapy is when we harness the immune system – the best personalized medicine in the fight against cancer.”
Today, there are already multiple drugs that are capable of harnessing the patient’s immune system. The challenge is that these drugs work only in around a third of patients while the remaining two-thirds are often left with few treatment options.
Markel’s team decided to try a novel approach: Rather than match the drug to the patient, they modify the patient to work with the immunotherapy drug.
Cancer cells can shield themselves from the immune system by secreting what are called decoy proteins or receptors. These proteins circulate in a patient’s bloodstream and block the capacity of the immune system to operate against the cancer. As such, even if existing immunotherapy drugs are administered, they cannot work at full capacity and their effectiveness is limited.
“The only way to neutralize these proteins is to get rid of them or filter them out of the blood stream, 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.
Immunicom of San Diego developed the technology to filter out these proteins, recently receiving a “Breakthrough” designation from the FDA for its system.
The company’s LW-02 plasma filtration system is a disposable device that is coated with a highly selective compound that binds only to these decoy receptors. When plasma is run through the device, it comes out without these decoy receptors.
The immunophoresis process can be equated to dialysis, which is used to draw a patient’s blood outside the body, filter out the toxins, and then return the blood back to the patient in a closed circle.
“By doing this process enough times, we think it will lower the suppressive receptors in the blood enough that the therapies will work,” Markel said.
He noted that the existence of these proteins has been known since the 1990s, but until now, no one has managed to get rid of them.
Markel said that the trial, which is funded by Immunicom with the support of a grant by the Samueli Foundation, will be executed by Hagit Harati, head nurse and co-founder of Sheba’s
Immunophoresis Unit. It is expected to take two and a half years.
“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.”
He said that with this trial, there is real hope “that we can really make that happen.”