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Immunicom – CE Mark Cleared Therapeutic Device Addresses Cancer in a Novel Way

Cancer immunotherapy has traditionally been both expensive, and especially in the case of T-cell therapy, riddled with toxic side effects.  Immunicom, a privately held, therapeutic device company based in San Diego, CA, is seeking to address these, as well as many of the other drawbacks of current immunotherapies.

The company received European regulatory approval through a CE Mark for its ImmunopheresisTM technology in 2020, after conducting trials in Europe at the University of Krakow and other leading sites.  Immunicom’s ImmunopheresisTM platform technology works by using molecular filters to capture from the patient’s blood, specific, immune suppressing factors released by solid tumors.  Immunicom has been classified by the FDA as a “Breakthrough Technology”, giving it a potential fast track through its US regulatory approval process. 

 

Immunicom’s platform allows it to rapidly develop new molecules that can target specific immune suppressing factors being produced by cancer cells and other terminal diseases.  By capturing disease specific cytokines and other factors outside of the body with its proprietary filter, Immunicom uses a safe and effective extracorporeal method to deliver therapeutic benefit while minimizing side effects and maximizing clinical response and quality of life.  The company uses plasmapheresis machines, which are commonly used at  hospitals around the world, to filter the patient’s blood.  The process typically takes about two to three hours to filter two plasma volumes of blood while the patient typically relaxes, reads, sleeps, or watches TV in an armchair, during the treatment.

 

Immunicom currently has an oncology immunotherapy product that has received approval in Europe and in clinical trials for multiple cancers around the world in Europe, Israel, Turkey, and starting in the US. The company has three other molecules currently in development with another four planned over the next 18 months

While there is significant data, dating back 25 years, that using plasmapheresis to filter cytokines is an effective treatment, Immunicom has solved two historical issues in the space – the ability to specifically remove only the target molecule and the ability to prevent leaching of the filtering molecule from the bead bed back into the patient.  The later achievement allows Immunicom to be classified as a Class II  device in Europe and a PMA device with Fast Track approval in the US, versus a drug, which would be required if any filter molecules leached back into the body.

 

The European trials which currently focus on Triple Negative Breast Cancer (a non-treatable aggressive form of breast cancer), resulted in the CE mark approval by showing significant improvement in the quality of life, significant extension of life, and stable disease in a significant number of end-of-life, triple-negative breast cancer patients with ImmunopheresisTM being used as a monotherapy – data to be published shortly.  The trial has now been extended to ImmunopheresisTM in combination with chemotherapy and is already demonstrating excellent outcomes.


The company is also conducting trials at Sheba Medical Center in Israel for melanoma and renal cancer and at the Acibadem Hospital System in Istanbul for lung cancer.  Immunicom recently scored very high on its NIH grant submission and received its pre-award letter from NIH to fund a direct-to-Phase II trials at Baylor College of Medicine beginning around July 2021, focusing on hormone receptor positive (ER+ and/or PR+) breast cancer that is not responsive to hormone therapy.

The Immunicom ImmunopheresisTM technology is unique in that it has shown very limited, if any toxicity, can be priced at a cost 1/10th that of CAR-T with significant margin, and can be offered at any hospital or location with a plasmapheresis machine – unlike some immunotherapies which are only offered at comprehensive cancer centers.  Further, ImmunopheresisTM is a platform technology and benefits from “regulatory arbitrage,” having IP on the extracorporeal use of molecules to treat cancer and other terminal diseases, but utilizing a much faster medical device regulatory approval pathway. 

 

The company is lead by Amir Jafri, the former VP/CTO, VP R&D and VP Operations at Cardinal Health.  Its Chairman, David Schlotterbeck, was the Former Vice Chairman of Cardinal, and CEO and Chairman of Carefusion. 

 

Immunicom, and its leadership, have won several significant awards and recognitions in the past year.  Amir Jafri was named a “Top Healthcare Leader” of 2020 by CEO Today Magazine, and Immunicom was recognized as a “Ten Most Promising 2020 Biotech Startup” by Startup City and an “Innovation Leader” by Life Science Intelligence.

 

Immunicom has been named Cancer Device Company of the Year – 2021 by MedInvest, and will be a presenting company at its Oncology Investor Conference Series hosted Monday, March 29 – Thursday, April 1.