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.”

Learn more at www.roswellpark.org.