Immunicom Clinical Trial Data at ASCO 2022 Show Immunopheresis® LW-02 Column Safe and Effectively Depletes Soluble TNF-α Receptors in Patients with Advanced Triple Negative Breast Cancer

Novel subtractive immunotherapy is designed to activate endogenous antitumor pathways by removing target proteins (sTNFRs) that promote tumor growth, survival, and mobility

Immunopheresis is a new and well-tolerated immuno-oncology option for advanced TNBC patients, both as monotherapy and adjunct therapy, without the potential side effects of conventional treatments

SAN DIEGO—June 2, 2022—Immunicom, Inc., a privately held clinical-stage biotechnology company with a transformative immuno-oncology platform, presented data from its ongoing clinical investigation [NCT04004910] at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting. The trial data, detailed by principal investigator Prof. Piotr Wysocki, show that the Company’s Immunopheresis® LW-02 Column is a safe, promising immunotherapy that helps spur upregulation of a patient’s TNF-α pathway—an endogenous cytokine broadly recognized for its anticancer characteristics.

As part of Immunicom’s ongoing clinical study, 28 patients with advanced triple negative breast cancer (TNBC) underwent 862 LW-02 Column Immunopheresis procedures. 10 patients received Immunopheresis LW-02 Column as a monotherapy, and 18 patients received it in addition to various chemotherapy regimens. As reflected in the trial data, subtractive therapy with the LW-02 Colum as a monotherapy or adjunct to chemotherapy is safe and achieves effective depletion of soluble TNF-α receptors from plasma. It was also noted that no serious device-related adverse events related to the LW-02 Column have been reported in the trial.

Therapy with the LW-02 Column was performed three times a week for at least 16 weeks by processing two plasma volumes via apheresis per treatment. After 30 minutes of therapy, the mean capture efficiencies for sTNF-R1 and sTNF-R2—the proteins shed by tumors that suppress endogenous TNF-α—were 95.2% and 79.6%, respectively. The LW-02 Column was also found to be highly selective in removing sTNF-R1 and sTNR-R2 from total plasma proteins. The mean total amount of sTNF-R1 & sTNF-R2 that leached from the LW-02 Column was 109 ng per apheresis session, many orders of magnitude lower than TNF-α concentrations known to trigger clinically meaningful effects.
Commenting on the trial data presentation, Immunicom Chief Clinical Officer Dr. Victoria Manax revealed, “LW-02 Column Immunopheresis data suggest that removing these factors is an increasingly promising modality for cancer patients. The ASCO abstract highlights both the LW-02 column’s efficacy and safety profile. Coupled with our AACR presentation last month, which shared results of the ongoing clinical benefit to patients, even patients with advanced stage cancers, we continue to find evidence that this is an exciting new option in immuno-oncology.”

Through the Company’s three ongoing global clinical trials, Immunicom continues to evaluate the safety and efficacy of LW-02 Column Immunopheresis for advanced TNBC as well as other solid tumor types. You can learn more about Immunopheresis and TNBC in Immunicom’s ASCO 2022 Abstract presentation.

Subtractive Therapy – Immunopheresis® and the LW-02 Column
Immunicom employs a proprietary, high-affinity, molecular capture-ligand binding matrix within the LW-02 Column to remove specific cytokine receptors, soluble TNF-Receptors 1 and 2 (sTNFR-1/2), that are shed by cancer cells into the extracellular tumor microenvironment. sTNF-Rs serve as decoys, binding to tumor necrosis factor alpha (TNF-α) before it can bind to its membrane-embedded sTNF-R receptors to trigger several cell death pathways. The selective removal of decoy sTNF-Rs by the LW-02 Column allows the patient’s immune system to identify and aggressively attack the cancer.

Immunopheresis, like dialysis, is a subtractive therapy that occurs outside the body, in contrast to conventional drugs and biologics that are infused into the patient. Immunopheresis is thus intended to be much better tolerated than chemo- and immunotherapies, allowing for its use as an adjunct with these therapies, possibly in lower doses to reduce their toxicity.

About Immunicom
Immunicom, Inc. is a privately held biotechnology company with a new technology platform for immuno-oncology. Immunicom’s highly selective Immunopheresis blood and/or plasma constituent removal technology is designed to effectively treat a wide variety of cancers and immunological disorders with a safer side-effect profile than conventional treatments. Immunicom’s lead product, the LW-02 Column, previously received FDA Breakthrough Device designation in 2018 for Stage IV metastatic cancer, and European regulatory clearance (CE Mark certification) in 2021 for use in patients with advanced, refractory, metastatic triple negative breast cancer. LW-02 Column Immunopheresis is currently being evaluated in several globally based oncology trials for multiple cancers. Immunicom is headquartered in San Diego, CA, with operations in Houston, TX, Philadelphia, PA, Krakow, Poland, and Istanbul, Turkey.