Hemispherx Biopharma and Roswell Park Plan Phase I/II Study of Ampligen Plus Checkpoint Inhibitors

Earlier Studies Showed Ampligen Produced a More Favorable Ratio of Killer T cells to Regulatory T cells in the Tumor Microenvironment, a Key to Improving Checkpoint Blockade Therapy

ORLANDO, Fla., May 31, 2018 (GLOBE NEWSWIRE) -- Roswell Park Comprehensive Cancer Center (Roswell Park) and Hemispherx Biopharma, Inc. (NYSE American:HEB) plan to expand their existing scientific collaboration to advance the clinical development of Ampligen – an investigational immune-enhancing TLR3 agonist – which has shown promise in preclinical studies when combined with checkpoint inhibitors (CPIs). The parties have executed a Memorandum of Understanding (“MOU”) designed to further assess the clinical potential of Ampligen in treating certain cancers.

A contemplated phase I/II study will evaluate the potential of Ampligen to enhance the immune mediated effects of CPIs in patients with advanced solid tumors. The study will seek to validate prior research that has demonstrated synergy with this combination in preclinical models. This study will be led by Pawel Kalinski, MD, PhD, who currently serves as the Vice Chair for Translational Research and Professor of Oncology in the Department of Medicine and as the Co-Leader for the Tumor Immunology & Immunotherapy Program at Roswell Park.

“Earlier clinical data demonstrated significant activity against metastatic renal cell carcinoma and melanoma. More recent preclinical studies combining Ampligen with checkpoint inhibitors have yielded very promising results,” said David Strayer, MD, Chief Scientific Officer of Hemispherx. “The objective now is to determine the optimal integration of Ampligen with standard checkpoint inhibitor therapy in the clinic in a variety of solid tumors with the goal of improving survival.”

“Enhancing the accumulation of cytotoxic T cells and enhancing their activation levels in the tumor microenvironment, as Ampligen has demonstrated in recent preclinical studies, is critically important to improving the effectiveness of PD1-targeted checkpoint inhibitors,” said Dr. Pawel Kalinski. “We are excited to expand our collaboration with Hemispherx and to embark on a clinical study designed to assess the promise of Ampligen in combination with checkpoint inhibitors across a variety of advanced solid-tumor settings.”

“We are delighted Roswell Park is expanding its collaborations with Hemispherx to study the combination of Ampligen and checkpoint inhibitors with a goal to improve and prolong the lives of people with advanced solid tumors,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “Finding ways to explore the full potential of Ampligen as an immune-enhancing therapy in combination with checkpoint inhibitors is one of our top priorities.”

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include FDA approved Alferon N Injection®, the only natural alpha-interferon product, and the ANMAT (Argentina) approved product for severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) known as rintatolimod (tradenames Ampligen® or Rintamod®). Outside of Argentina, Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, with a priority focus on solid tumor malignancies. Based on experience to date in ME/CFS, with nearly 100,000 doses administered intravenously (IV) to human subjects in clinical settings, Rintatolimod has been generally well tolerated. Due to the fact that Rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.

About Roswell Park Comprehensive Cancer Center
Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. 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. Among other uncertainties, the MOU is non-binding on all parties and memorializes the intention of the parties to continue and broaden their collaborative efforts. Furthermore comprehensive activities are subject to the parties agreeing to enter into definitive agreements. In addition, the planned study, if undertaken, will be preliminary and non-clinical and Ampligen’s® ability to treat or assist in the treatment on pancreatic cancer, while promising, will require significant additional testing and no assurance can be given that Ampligen® will prove effective in such treatment. 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.

Contacts:
Hemispherx Biopharma
Phone: 800-778-4042
Email: IR@hemispherx.net

Annie Deck-Miller, Roswell Park
Phone: 716-845-8593
Email: annie.deck-miller@roswellpark.org

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