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Capturing the Power of Immune Response to Treat Disease

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Capturing the Power of Immune Response to Treat Disease MEDICAL & PHARMACEUTICAL CAPTURING THE POWER OF IMMUNE RESPONSE TO TREAT DISEASE Hemispherx Biopharma, Inc. is a specialty biotech with unique technology platforms for treatment of seriously debilitating disorders. Hemispherx Biopharma is seeking commercial partners to advance drugs for immuno-oncology, infectious disease and immune dysfunction. Biotech Bounce Back Company: Hemispherx Biopharma, Inc. Name: Thomas K. Equels, CEO Email: [email protected] Web Address: www.hemispherx.net Address: 1617 JFK Blvd., Suite 500, Philadelphia PA 19103 Telephone: +1 215-988-0080 24 MEDICAL & PHARMACEUTICAL rug discovery today is based on Ampligen has been generally well-tolerated in the severe and disabling form of ME/CFS. understanding the power of unique controlled human clinical trials believed to be, Hemispherx has completed Phase II/III trials D technologies combined with an at least in part, due to the selectivity of TLR3 with Ampligen and is currently in discussions enhanced understanding of the human activation. with the Food and Drug Administration (FDA) response systems. Hemispherx Biopharma on the design of a confirmatory phase III study. (NYSE MKT: HEB) is set for today’s biotech One of the largest growing arenas in cancer Ampligen is the only drug targeted specifically bounce back as the pharma industry aims at treatment today are PD-1 inhibitors. Although for ME/CFS and Hemispherx believes it is the effective therapies tailored specifically to the highly effective in a minority of cancer only late stage drug in the pipeline. Ampligen populations who will respond best to them patients, the majority are not benefitted by has been granted orphan drug status for the while avoiding unnecessary exposure to other this new drug class which are associated CFS indication. Equels noted, potentially toxic therapies. with significant treatment toxicities. There is a race to find drug combinations to improve Hemispherx’s flagship products include the the effectiveness of these PD-1 inhibitors. In “We are very interested in finding experimental therapeutics Ampligen® and initial studies, TLR3 activation in combination a commercial partner who has Alferon® LDO, as well as the commercially with checkpoint inhibitors (anti-PD-1 / PD- approved product, Alferon N Injection®. These L1), has shown synergy in mouse models. the expertise to commercialize drug platforms are designed to modulate the Ampligen has demonstrated synergistic ability this product. Because no other immune system, functioning as activators of to improve reduction in cancer tumor size drug targeted for CFS has the immune response with pluripotent activity. in mouse models. Pawel Kalinski, MD at the They have the potential to target large unmet University of Pittsburgh has demonstrated advanced as far as Ampligen, medical needs in infectious disease, immune in humans apparent effects of Ampligen to once approved for commercial dysfunction and cancer. model the tumor microenvironment that favors immune attack, which is currently a focus sales, we believe that there may The Advantages of a Selective TLR of scientific attention in immune-oncology. be no competitive therapies.” The experimental drug Ampligen (rintatolimod) In addition to its apparent remodelling of is a synthetic double-stranded ribonucleic the tumor microenvironment, Ampligen Having secured patent protection for Ampligen acid (dsRNA) that is a selective TLR3 agonist activates immature dendritic cells essential (rintatolimod) through 2029, Hemispherx that stimulates adaptive and innate immune to an effective immune response and can be announced in August 2016 that it had received response that minimize systemic cytokine considered an “immune driver”. The market approval of its New Drug Application (NDA) from responses. Ampligen is a new class of growth of checkpoint inhibitors is expected to Administracion Nacional de Medicamentos, specifically configured dsRNA. TLR3 is a exceed $16 billion. Alimentos y Tecnologia Medica (ANMAT) for specific intracellular signalling system that commercial sale of the drug in the Argentine responds to dsRNA produced during viral Early studies in cancer treatment have Republic, where it is poised to make a significant infections. demonstrated that Ampligen has significant impact in the treatment of severe CFS. In clinical activity against renal cell carcinoma addition, Hemispherx is working to expand Humans possess ten Toll-like Receptors (TLRs), and melanoma. According to CEO Thomas the approval of rintatolimod to additional which provide initial inhibitory responses for Equels, M.S., J.D., “We believe Ampligen is countries, with a focus on Latin America, with invading micro-organisms (innate immunity). especially well-positioned for possible use in the marketing assistance of their commercial TLRs recognize structural patterns within combination with other drugs in the immuno- partner in the region, GP Pharm. microbes and respond by transiently activating oncology space due to its activity as a driver of hundreds of genes, producing a variety of the immune response and has been generally This approval for commercial sale in Argentina biological responses. Over the last decade, well-tolerated, even in long-term human provides Hemispherx with a major platform from toxicities associated with TLR technology have administration. Ampligen has been granted which to launch future potential commercial been seen as a barrier in drug development. orphan drug status by the FDA in both renal cell sales in certain countries within the European TLR3, however, has a unique cytoplasmic carcinoma and melanoma.” Union, under regulations that support cross- signalling system that provides it with specific border pharmaceutical sales of licensed drug development advantages. All other TLRs Mr. Equels previously served as General Counsel drugs. In Europe, approval in a country with utilize a pro-inflammatory signalling system and Chief Financial Officer at Hemispherx a stringent regulatory process in place, such that utilizes the MyD88 cytoplasmic signalling Biopharma in addition to serving as a Director as Argentina, adds further validation for the mediator. TLR3 uses the TRIF mediated since 2008. After becoming President, Mr. product as the Early Access Program (EAP) is pathway. The TRIF pathway, moreover, has Equels was named Chief Executive Officer in launched in Europe. The Company believes that acute toxicity responses that are species February 2016, and brings to the table extensive rintatolimod, a new class of macromolecular specific with primates demonstrating the experience in international business, contracts, dsRNA drug, is the first drug to receive approval lowest toxicity. intellectual property, trade secrets, sales for this indication anywhere in the world. and distribution of goods, and collaborative Ampligen (rintatolimod) is a specifically counsel. Tackling Dangerous Infectious Diseases configured TLR3 agonist, which minimizes In an experiment using Ampligen, conducted systemic inflammatory cytokine induction. Product Launch with Right Commercial Partner by the independent US Government facility, Crucially, unlike more promiscuous TLR3 Ampligen is currently being developed for the USAMRID, rodents were challenged with the agonists, Ampligen is a selective TLR3 agonist, treatment of Myalgic Encephalomyelitis/ Ebola virus and showed potential efficacy which does not activate the pro-inflammatory Chronic Fatigue Syndrome (ME/CFS), a serious as an early-onset therapeutic or potential cytosolic dsRNA helicases (RIG-l and MDA5). chronic disease. Hemispherx’s focus is on prophylactic. In this experiment, all of the 25 MEDICAL & PHARMACEUTICAL rodents infected with Ebola virus, but not large variety of approved indications. In a treated with Ampligen, died. However, in the recent review of the field, natural interferon low dose Ampligen group, there was 100% (n-IFN) was not associated with the generation survival with no Ebola related weight loss. of neutralizing IFN antibodies. The Journal of These results indicate a high level of bioactivity Interferon and Cytokine Research reported that in this experimental setting. Similar bioactivity patients who became refractory to r-IFN, when has been seen in a number of other animal switched to a natural interferon were restored model experiments with other viruses that to approximately 82% clinical effectiveness. are highly lethal, such as Venezuelan equine Re-examining the efficacy of natural interferon encephalitis and the SARS virus. Hemispherx in recombinant IFN treatment failures opens a believes that Ampligen may have utility against wide range of therapeutic targets. Alferon N is a variety of emerging viruses with lethal approved in Argentina for patients failing r-IFN. pandemic potential. Hemispherx’s product Alferon N is an approved Another component of the Ampligen portfolio FDA product for adults with reoccurring/ is as an immune driver for viral vaccines, refractory HPV (genital warts), which is the most such as influenza. Extensive studies on common sexually transmitted disease. The influenza conducted at the Japanese National pivotal study showed that 54% of Alferon N Institute of Infectious Diseases by Dr. Hideki treated patients had a complete response of Hasegawa on seasonal and highly pathogenic all treated warts. Genital warts are a source (birds and humans) avian H5N1 influenza of physical discomfort, including pain, bleeding virus demonstrated sterilizing immunity in and itching, and a source of psychosocial mucosal vaccine
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