Hemispherx Biopharma, Inc. announced Roswell Park Comprehensive Cancer Center Institutional Review Board (“IRB”) approval and shipment of Ampligen to start an oncology clinical study combining its dsRNA TLR3 agonist Ampligen with Merck’s Keytruda (pembrolizumab) in Metastatic Triple Negative Breast Cancer. The study will enroll at least six participants and be conducted by Drs. Mateusz Opyrchal and Pawel Kalinski at Roswell Park, a National Cancer Institute-designated comprehensive cancer center in Buffalo, New York. This trial will study how well Ampligen-based chemokine modulation therapy works when given prior to Keytruda in treating participants with triple-negative breast cancer that has spread to other places in the body. Drugs used in this chemokine modulation therapy — celecoxib, recombinant interferon alfa-2b, and Ampligen — work by unleashing or enhancing the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Monoclonal antibodies such as Merck’s Keytruda interfere with the ability of tumor cells to grow and spread when present in a “hot” tumor microenvironment (that is - Teff cells outnumber Treg cells). The clinical trial tests whether chemokine modulation therapy before Keytruda will work better than Keytruda alone in treating participants with metastatic triple-negative breast cancer by altering the tumor microenvironment to favoring immune rejection. Studies from the University of Pittsburgh and Roswell Park Comprehensive Cancer Center, in preclinical models and human tumor explants have demonstrated that Ampligen is a TLR3 restricted and targeted modulator of “hot” tumor microenvironments (Nature Protoc. 2018 Feb;13(2):335-357 and Cancer Res. 2018 Aug. 1;78 (15):4292-4302). The study will enroll 6 participants with unresectable or metastatic triple negative breast cancer who will undergo a pre-treatment biopsy. Participants then receive two cycles of chemokine modulation therapy consisting of celecoxib, recombinant interferon alfa-2b, and Ampligen/rintatolimod (three days of treatment per cycle). Participants will then undergo an additional biopsy. Following the biopsy and chemokine modulation therapy, participants receive Keytruda every three weeks for two cycles. A second clinical trial combining Ampligen with Keytruda in ovarian cancer and a cohort of forty subjects is scheduled to launch later this month at the University of Pittsburgh. This clinical trial in which Hemispherx supplies the Ampligen, and Merck the Keytruda plus funding assistance is sponsored by the University of Pittsburgh. It will be an important and more extensive test of Ampligen as an immune system primer that can change cold tumors into hot tumors, thereby making the formerly cold tumors more responsive to Keytruda.