Immunicom Presents Promising Preliminary Data from Immunopheresis® Studies in Late-Stage Cancer Patients at JCA-AACR 2021

LW-02 Immunopheresis^® therapy shown to be safe and well-tolerated in treating late-stage cancer patients who failed multiple lines of standard therapies

Immunopheresis^® is a breakthrough immunotherapy designed to remove immune-suppressive cytokines via a selective extracorporeal blood-filtering column

SAN DIEGO–(BUSINESS WIRE)–#biotech—Immunicom, Inc., a clinical-stage biotechnology company pioneering “subtractive” advanced cancer therapies, presented promising preliminary data from trials investigating Immunopheresis^® therapy for metastatic, refractory, solid tumor cancer patients who previously failed multiple lines of therapy. The results presented by Immunicom’s Chief Medical Officer, Dr. Robert Segal, at the JCA-AACR Precision Cancer Medicine International Conference virtual joint conference established that Immunopheresis therapy administered to end-stage cancer patients was generally well-tolerated and has the potential for treating refractory malignancies.

Immunicom’s ongoing clinical trials are in the most difficult to treat, late-stage cancer patients. Immunicom’s novel Immunopheresis therapy uses its proprietary subtractive LW-02 column to selectively remove immune-suppressive cytokines produced by cancer tumors.

“Standard cancer treatments are surgery, radiation or those that typically require the infusion of drugs, antibodies or proteins into the patient. Although chemotherapy and the available immunotherapy drugs can be effective, introducing these foreign substances into the body frequently leads to toxic side-effects, often severe enough to require that the dose be reduced or the therapy be discontinued entirely,” said Immunicom’s Chief Medical Officer, Dr. Robert Segal. “At Immunicom, we have developed a novel approach to treat cancer by safely removing specific cytokines to boost the immune system to potentially fight cancer cells. The Immunopheresis therapy is an extracorporeal treatment and is thereby designed to be safer and with less risk of typical side-effects seen with standard chemotherapy and immunotherapy treatment regimens.”

Dr. Segal’s presentation focused on results from over 1,100 Immunopheresis procedures conducted in 40 end-stage cancer patients from ongoing clinical trials, demonstrating the viability of this technology as a new treatment strategy. The multinational clinical trials are evaluating the LW-02 column for treating multiple cancers, including triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. The LW-02 column is being investigated both as a monotherapy and in combination with low-dose chemotherapy or the well-known immunotherapy checkpoint inhibitors Opdivo^® (Bristol-Myers Squibb) and Tecentriq^® (Roche). These trials are being conducted in collaboration with world-renowned research organizations and thought leaders including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD;

Israel – at Sheba Medical Center’s Ella Lemelbaum Institute for Immuno-Oncology (Tel Aviv), under the direction of Dr. Ronnie Shapira, MD and Prof. Gal Markel, MD, PhD; and

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD.

Subtractive Therapy – Immunopheresis™ and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokines produced by cancer tumors. Selective removal of these targeted cytokines is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms which are significantly compromised in late-stage, metastatic disease and thereby “re-energizes the immune system to aggressively fight cancer.” Immunopheresis is a “subtractive therapy,” in contrast to drugs that are “additive.” Subtractive therapy is meant to avoid the side effects, toxicity and negative impact on a patient’s quality of life typical of other cancer treatments.

Based on Immunicom’s clinical program, the LW-02 column could be used either in combination with other therapies or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA) and European regulatory clearance (CE Mark certification) for use in adults with advanced, refractory TNBC. Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

For an overview of how Immunopheresis breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.

To view Dr. Segal’s presentation for the JCA-AACR Precision Cancer Medicine International Conference please see the conference website.

About Immunicom

Immunicom, Inc. creates novel immunotherapies designed to treat a variety of diseases using its breakthrough Immunopheresis™ technology platform to improve patient access and affordability. The privately held medical technology company develops innovative, non-pharmaceutical approaches for treating cancer, autoimmune disorders, and inflammatory and renal diseases. Immunicom’s revolutionary blood-filtering Immunopheresis technology has the potential to effectively treat a wide variety of cancer types, including those that have not responded to other treatment strategies, with possibly fewer side effects. Immunicom’s lead product, the LW-02 column, has received U.S. FDA Breakthrough Device designation for stage IV metastatic cancer and European regulatory clearance (CE Mark certification) for use in adults with advanced, refractory, triple negative breast cancer (TNBC). Immunopheresis is currently being evaluated in several global oncology trials for multiple cancers. Immunicom is headquartered in San Diego, CA with operations in Philadelphia, PA, Houston, TX, and Krakow, Poland.

About JCA and AACR

The Japanese Cancer Association (JCA) and the American Association for Cancer Research (AACR) hosted their first inaugural conference, JCA-AACR Precision Cancer Medicine International Conference, to bring together the greatest minds from the United States, Japan, and around the world to share the latest and most exciting developments in precision cancer medicine. JCA is an association under the Japanese Association of Medical Sciences with the purpose to promote cancer research. Found in 1908, the association has 15,000 members, hosts numerous academic meetings, and publishes a journal, Cancer Science. AACR is the largest cancer research organization dedicated to prevent and cure cancer. Through its programs and services, the AACR fosters research in cancer and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer etiology, prevention, diagnosis, and treatment throughout the world.

Forward Looking Statements

This press release contains certain forward-looking statements regarding Immunicom device capabilities. All such statements are based upon current Immunicom expectations and involve a number of business and technical risks and uncertainties that could cause actual results to differ materially from anticipated results described, implied or projected in any forward-looking statement, including, without limitation, clinical trial results, regulatory approvals, unexpected changes in technologies, uncertainties inherent in product development and commercialization, intellectual property protection, and the ability of our products to gain market acceptance.

Contacts

Stephen Prince

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657-202-6040