Day 2 :
Time : 08:00-08:25
Ronald Moss, M.D. has served as the Chief Executive Officer of Ansun Biopharma, Inc. since October 2012, and before that, served as both interim CEO and Executive Vice President of Clinical Development and Medical Affairs at Ansun from 2008 to 2012. Dr. Moss has held various executive positions in the pharmaceutical industry for over 20 years and has played a pivotal role in successfully leading companies through the complexities of drug and vaccine development. Dr. Moss has been involved in drug and vaccine development of products in Infectious Disease, Allergy, Neurology, Dermatology, Oncology, Respiratory, Transplant, and Autoimmunity in both large pharmaceutical and biotechnology companies, including roles at Aventis, Immune Response, Merck, Telos and Vical. He has also authored over 70 scientific publications. Prior to joining industry, he received his M.D. degree from Chicago Medical School, completed a residency in pediatrics at SUNY Stony Brook and completed a fellowship at the National Institutes of Health. He is double boarded in Pediatrics and Allergy and Immunology. He is also a Fellow of the American Academy and American College of Allergy and Immunology.
Vaccines and antivirals are currently the main approaches to prevent and treat respiratory virus infections such as influenza. The recent 2009 H1N1 pandemic and the H7N9 outbreaks exemplify the unpredictable nature of influenza viruses. Particularly concerning is the documentation NAI drug resistance to particular strains of influenza. DAS181, is an investigational host directed inhaled sialidase fusion protein and has shown in vitro and in vivo activity against many subtypes and strains of influenza virus including H7N9 and H5N1. Data will be presented from preclinical and late stage clinical studies of DAS181 against influenza. Parainfluenza lower track infection results in significant morbidity and mortality in immune-suppressed transplant patients without any licensed vaccines or antiviral drugs. In addition, the drug has shown in vitro and in vivo activity against parainfluenza virus strains (PIV-1, PIV-2, PIV-3, and PIV-4) by inactivating the virus binding receptors. DAS181 has been utilized in over 80 EIND’s, and a phase 1 study of transplant patients with severe PIV infection. Interestingly, DAS181 has also shown significant in vitro activity against other viruses including EV-68, JC, and BK. The host directed approach of DAS181 contrasts with virus specific antivirals, by circumventing considerable problems related to antiviral drug resistance, and the need for prediction of strains for effective vaccines. DAS181, an investigational drug, is currently in Phase 2 clinical trials of parainfluenza infection. Preclinical and clinical data from studies with DAS181 activity against a variety of pathogenic viruses will be presented.
University of Pennsylvania,USA
Time : 08:25-08:50
Sita Awasthi has received her Ph.D in Biochemistry from Devi Ahilya University at Indore, India and her postdoctoral training from University of Pennsylvania at Philadelphia. Currently she is a Research Assistant Professor at University of Pennsylvania, Pearlman School of Medicine, Infectious Disease Division. Her research interests are HSV-2 vaccine development against genital herpes disease and HSV-2 HIV-2 co-infections. She has published numerous research articles and serving as an editorial board member of Journals of antivirals and anti retrovirals, Journal of Immunoassay and Immunochemistry.
About 500 million people are infected with Herpes Simplex Virus type 2 (HSV-2) worldwide. Genital HSV-2 infection is one of the major causes of genital ulcer disease and the risk of HIV-1 acquisition and transmission by 3-4 fold in humans. Efforts to prevent genital ulcer disease with acyclovir failed to reduce HIV-1 acquisition or transmission, supporting the need for an effective vaccine. We developed a trivalent gC2/gD2/gE2 (HSV-2 glycoprotein C, D and E) subunit vaccine that generates high levels of neutralizing antibodies, blocks HSV-2 immune evasion from complement, blocks IgG-Fc binding to the HSV-2 IgG Fc receptor, and is highly efficacious in preventing genital disease and viral shedding in guinea pigs. Here we present an immunogenicity evaluation of gC2/gD2/gE2 vaccine in macaques. Female macaques were immunized three times four weeks apart with 20g of each gC2, gD2, and gE2 glycoprotein or 20g gC2 alone with CpG and alum as adjuvants. After the third immunization, plasma analysis showed high titer antibody responses to each antigen, high titer neutralizing antibodies, and antibodies that blocked complement C3b binding to gC2 and IgG Fc binding to gE2. Six months after the third vaccination, the immune responses to each glycoprotein had declined 2-3 fold, but boosted within 2-weeks after a booster immunization administered at 9 months. Additionally we detected antigen specific antibody response in vaginal fluid. Importantly, analysis of PBMCs from macaques that were immunized with gC2 alone, showed a gC2 specific CD8 T cell response after 3 immunizations. In addition, antigen specific poly-functional CD4 T cell responses are induced in the trivalent vaccine group. Our results show that the trivalent gC2/gD2/gE2 subunit antigen vaccine generates highly potent immune responses in Rhesus macaques and may prove to be a promising genital herpes vaccine candidate for future trials in human.