The Phase II Study Will Combine Hemispherx’s Ampligen with Keytruda

OCALA, Fla., Jan. 08, 2019 (GLOBE NEWSWIRE) — Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, announced today 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 (i.e. – 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.

“At Team Hemispherx we are determined to pursue an aggressive R&D program focused on improved immune therapies for lethal malignancies, and we are grateful for the support and attention we are getting from big pharma and these major research institutions,” said Hemispherx CEO Thomas K. Equels. “The work beginning at Roswell Park Comprehensive Cancer Center is an important step in Hemispherx’ overall clinical plan in immuno-oncology. Relevant preclinical experiments in several types of solid tumors and conducted at different major U.S. cancer research centers support the proposition that Ampligen can change the micro-environment of tumors so as to create a robust and significant positive synergy with check point blockade therapies. We have seen a clear synergistic effect in our laboratory studies, and human tumor explants indicate this phenomenon is extended to humans. To the extent this follows through in vivo with humans in these clinical trials, that synergy with the checkpoint inhibitors will put Ampligen at the forefront of a major medical breakthrough in immuno-oncology.”

Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

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