Phase I Study to Evaluate alpha-TEA in Combination With Trastuzumab (HerceptinTM) in Patients with Advanced HER2 Positive Breast Cancer
Portland, OR July 24, 2020
Veana Therapeutics Inc. is pleased to announce that it has entered into a clinical research collaboration with the University of Washington to conduct a Phase I clinical trial of its lead agent, alpha-TEA (aka a-TEA lysine) in combination with trastuzumab (HerceptinTM) in HER2+ breast cancer patients. a-TEA lysine salt is a novel, first-in-class small molecule that destabilizes mitochondria (energy powerhouses) of proliferating cancer cells to induce apoptosis and cause release of “danger signals” that stimulate cells of the immune system to recognize and destroy cancer cells.
The Veana-sponsored Phase I single site dose-escalation study at the University of Washington is designed to evaluate the safety and clinical response of oral alpha-TEA when used in combination with HER2-specific monoclonal antibody, trastuzumab (HerceptinTM) to treat Stage IV HER2+ breast cancer patients who have been treated with definitive therapy and received maintenance HER2-targeted monoclonal antibody therapy (defined as trastuzumab monotherapy or combination trastuzumab and pertuzumab therapy); and currently have progressive disease. Secondary objectives include evaluation of changes in levels of activated memory T cells, frequency of HER-2-specific T cells and function of Natural Killer (NK) cells. As an exploratory objective, the study will assess the status of Th1 (Tbet+) and Th2 (GATA3+) CD4+ and CD8+ T cells in the tumor microenvironment. The study, (NCT04120246) is open and is currently enrolling patients.
“We are honored to collaborate with the University of Washington and renowned breast cancer oncologists, Drs. Mary (Nora) Disis, MD and William Gwin MD, who will be leading the study for their commitment to bringing new treatment options to the clinic that have the potential to improve clinical outcomes in cancer patients with minimal impact on their quality of life” said Emmanuel T. Akporiaye, Ph.D., Founder and Chief Executive Officer of Veana Therapeutics. “Alpha-TEA represents a new approach to immunotherapy acting in concert with standard treatments to determine if we can improve outcomes for patients” said Dr. Disis. “We look forward to bringing Alpha-TEA into the clinic to provide our patients a new promising immune based therapy” said Dr. Gwin.
Alpha-TEA (aka a-TEA lysine) salt is a novel scalable, orally administered analog of alpha-tocopherol that has been chemically modified for the treatment of human cancer. This modification renders the analog redox-silent and endows it with tumor cytotoxic properties both of which are absent in the parent alpha-tocopherol molecule. a-TEA kills malignant cells at doses that are not harmful to normal cells. A mechanism of action of VIMO is destabilization of tumor cell mitochondria to generate reactive oxygen species that trigger cell death through direct apoptosis and autophagy. The resulting tumor cell death concomitantly stimulates the release of “danger signals” [e.g. heat shock proteins (HSPs)], and antigen-containing autophagosomes which stimulate dendritic cells to drive antigen cross-presentation and activation of T cells resulting in a type of “auto-immunization”
About Veana Therapeutics
Veana Therapeutics, Inc. is a privately held, clinical stage, research and development biotechnology company whose primary mission is to develop safer, more effective oral therapies that will improve and extend the lives of the many people affected by the deadly disease of cancer. The company was founded in 2012 and is based in Portland, Oregon. Veana has developed a pipeline of proprietary innovative cancer therapy products that have been validated in proof-of-concept pre-clinical and clinical studies. Veana’s initial objective is to deploy its pipeline products as safe adjuvant therapies that will improve the effectiveness of commonly prescribed cancer immunotherapy treatments. Veana is dedicated to developing its first-in-class oral anti-cancer therapy technology for use on a range of cancer disease types including breast, prostate, ovarian, colon and esophageal cancers and children’s rhabdomyosarcoma. For more information, please visit Veana’s’ website at https://www.veana-therapeutics.com/
Contact Us About the Study
University of Washington
Cancer Vaccine Institute
www.clinicaltrials.gov reference number: NCT04120246