Hemispherx Biopharma, Bioclones join forces on novel therapeutic cancer vaccine

On June 25, 2014, Bioclones and Hemispherx concluded strategic discussions in Johannesburg with three principle goals; 1) initiating studies utilizing Ampligen as a potential adjuvant enhancement of Bioclones’ therapeutic cancer vaccine, currently in clinical trials in Cape Town, including pre-clinical studies followed, potentially, by a Phase 1 clinical trial; 2) seeking South African Medicine’s Control Council approval to conduct trials using Alferon(R) to eradicate the HIV virus in patients highly responsive to anti-retroviral therapy (HAART); and 3) initiating a joint effort to obtain commercial registration of both Ampligen(R) and Alferon(R) in the South African markets.

The first clinical program builds on the Bioclones patented (US Patent 7,981,673 entitled "Process for the maturation of dendritic cells and a vaccine") therapeutic human dendritic cell (DC) cancer vaccination approach. This invention provides a method of producing mature DCs in vitro, which comprises the step of culturing the immature DCs, thereafter exposing said cells to tumor antigens before administration to patients.

The team has successfully obtained the necessary Ethics approval to use Ampligen(R) as an adjuvant in the Bioclones pre-clinical cancer immunotherapy program utilizing patient derived samples. Pre-clinical studies will be directed towards the potential treatment of breast cancer in particular, followed by prostate cancer.

These studies are part of the effort to develop patient-specific DC immunotherapy vaccines against breast cancer and prostate cancer, which elicit an immune response that will target and kill cancer cells. Human DCs matured with Ampligen(R) and transfected with autologous tumor-specific mRNA are designed to elicit a potent and autologous tumoricidal antigen-specific cytotoxic response to the cancer.

Similar programs were successfully developed in the US at the Dendreon Corp., and Hemispherx currently has existing immunotherapy studies in the US at the University of Pittsburgh Comprehensive Cancer Center and the Georgia Regents Research Institute. The Bioclones collaboration is designed to enlarge and enhance the potential clinical results with the US based programs.

Ismet Amod, CEO of Bioclones, stated, "We and the University of Cape Town based research team led by Kamsellin Chetty are very excited about securing Ampligen from Hemispherx for the clinical work on dendritic cell vaccine technology which is an essential component in our novel treatment to fight cancer."

The already substantial Hemispherx patent estate related to Ampligen(R) was recently expanded with a new composition of matter patent. On May 13, 2014, the United States Patent Office issued patent US 8,722,874 B2 titled "Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity" to Hemispherx Biopharma, Inc.

The patent describes a novel form of rugged dsRNA, which is a key component of the company’s experimental drug Ampligen(R), and which displays a unique composition and physical characteristic identified with high specificity of binding to Toll-Like Receptor 3 (TLR3), thereby conveying an important range of therapeutic opportunities.

The Hemispherx inventors discovered, using highly sophisticated analytical methods, that within the mixture of Ampligen(R) RNAs of different sizes and molecular configurations, a highly specific subset of molecules — not previously known to exist — in fact convey a disproportionately higher percentage of the resultant biological activity believed to be important in the immunotherapeutic response to cancer.

Thomas Equels, Executive Vice Chairman of Hemispherx, stated, "This is another important step forward in the globalization of Hemispherx as well as the sharing of our important experimental immune system therapies with the world. We look forward to collaborating with Bioclones, our partner in South Africa, as we work together to maximize the potential use of Ampligen(R) and Alferon(R) in the treatment of cancers and HIV."