Sheba Medical Center at Tel HaShomer and Immunicom, Inc. are initiating a ground-breaking clinical trial to evaluate the clinical effectiveness of the Immunicom LW-02 plasma filtration device as a monotherapy and in combination with an anti-PD-1 immune checkpoint inhibitor. Sheba Medical Center, which is located in metro Tel Aviv, Israel, is the largest medical facility of its kind in the Middle East and was recently ranked as one of the top 10 Best Hospitals in the World by Newsweek magazine.
Immunicom is significantly accelerating its evaluation of the Immunopheresis™ therapy by teaming up with Sheba Medical Center and its world-renowned principal oncology investigator, Professor Gal Markel. This is the first trial where we are combining our novel Immunopheresis therapy with a market-leading checkpoint inhibitor immunotherapy drug."
Amir Jafri, Founder and CEO, Immunicom, Inc.
Utilizing a process similar to dialysis, Immunopheresis therapy is a non-pharmaceutical solution for treating cancer by using the LW-02 device to remove the harmful excess of immune-suppressive cytokines inhibitors produced by cancers to block the natural immune response to kill these tumors. The LW-02 device has received Breakthrough Device designation for stage IV metastatic cancer from the U.S. Food and Drug Administration (FDA).
The 40-patient clinical study conceived and led by Principal Investigator, Professor 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.
"Immunicom's innovative treatment approach neutralizes cancer's ability to block the patient's natural immune defense mechanisms, which are usually exhausted when the patient is suffering from metastatic disease," said Markel. "The approach is based on selective extraction of soluble proteins that shield tumors, to activate the patient's immune system to fight cancer aggressively. This 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. Hagit Harati, head nurse and co-founder of the newly established Immunopheresis Unit at Sheba, will be responsible of trial execution."
The trial was made possible via a grant from the Samueli Foundation, which supports integrative health initiatives in the U.S. and Israel, and funded the establishment of the Integrative Immuno-Oncology Program (I2O) at Sheba's Ella Institute, led by Professor Markel.
Dr. Wayne Jonas, Director of Samueli Foundation's Integrative Health Program, has had a particular interest in this therapy's potentially unique ability to filter out some of the key biologic facilitators of cancer growth for many years. This drove Jonas and the Samueli Foundation to collaborate with Immunicom to co-fund Professor Markel's clinical evaluation of this novel new immunotherapy approach for treating cancer.
For an overview of how this breakthrough technology works see: https://www.immunicom.com/how-it-works. Immunopheresis is an investigational therapy that has not yet been approved for use by the FDA or proven safe and effective for the treatment of any cancers. In addition to this new clinical evaluation of Immunopheresis at Sheba Medical Center to treat several cancers, Immunopheresis is currently being evaluated in Poland to treat triple-negative breast cancer (TNBC) in an ongoing clinical trial.