Phase II Amount
$1,072,330
Immunicom is focusing its clinical efforts on validating a first-of-its-kind, breakthrough immunotherapy device for treating a wide range of solid tumor cancers. The device, a subtractive immunopheresis column, specifically reduces circulating soluble receptors for TNF-? (sTNF-Rs) that inhibit TNF-?s tumoricidal and immunomodulatory activity . This therapeutic approach is designed to enhance the patients own innate humoral immune response. Immunicoms goal is to demonstrate this immunotherapy option for patients with refractory/late stage cancers, that provides more effective outcomes in terms of progression free survival, while maintaining quality of life measures while on therapy. Immunicoms clinical program is to develop its immunopheresis technology, in combination with best treatment practices for cancer patients, using todays most advanced therapy options. Immunicom is proposing a trial of the LW-02 immunopheresis device, at Baylor College of Medicine, for treating refractory, metastatic hormone resistant breast cancer. Patients with ER+/Her2- breast cancers that have failed both hormonal therapy, and chemotherapy, often have few choices for continuing therapy, resulting in an unacceptably poor 5 year outcome for most of these patients. Immunicom is proposing an exploratory study in 12 subjects to primarily evaluate safety and tolerability of its immunotherapy LW-02 device in this breast cancer population. Efficacy will focus on pull down of sTNF-Rs from the patients circulating blood. Breast cancer patients that have failed at least two lines of hormone therapy, and one to two lines of chemotherapy will be recruited to receive monotherapy with the LW-02 device, over a four week period, then in combination with eribulin chemotherapy, for an additional 12 weeks. Throughout treatment, patients will be monitored for reduction of circulating sTNF-Rs and adverse events. Objective response/clinical benefit will be exploratory; quality-of-life/clinical function, circulating tumor cells and markers of an immunologic response (including in tissue) will be evaluate too. Clinical response to treatment/tumor burden will be monitored by RECIST v1.1/iRECIST criteria (MRI/CT). Follow-up for up to 1 year will include evaluating subjects for progression free survival (PFS), best overall response (BOR), overall response rate (ORR), and overall survival. This exploratory study will provide critical safety and effectiveness data in refractory ER+/HER2- breast cancer, for Immunicom to pursue a larger efficacy study in this specific cohort of patients and expand on the encouraging body of safety, tolerability and effectiveness data emanating from ongoing studies in TNBC, NSCLC, melanoma and other solid tumor. This trial will demonstrate if immunopheresis could be a therapeutic option for treating refractory, hormone resistant breast cancer, alone or with chemotherapy regimens. With breast cancer the second most common cancer and leading cause of death in women, additional therapeutic options are needed to provide better outcomes for patients with advanced disease. Public Health Relevance Statement Narrative: Immunicom is developing a first of its kind immunotherapy (IMMUNOPHERESIS®) device, with FDA device breakthrough designation, for treating a wide range of solid tumor malignancies, including treatment-refractory breast cancer, through a whole blood filtration process that can stimulate the patients own immune system to attack their cancer. This work will demonstrate initial safety and efficacy of the immunotherapy device for treating breast cancer patients who are refractory to hormone therapy, alone and in combination with standard chemotherapy. With breast cancer the second most common cancer in women, and the leading cause of cancer death in women, additional therapeutic options to provide better outcomes for patients with refractory breast cancer that can also improve quality of life while on therapy are needed (a key advantage of immunopheresis versus standard chemotherapy).
Project Terms: <(TNF)-α> 