Althea Technologies & Profectus Biosciences Sign Manufacturing Agreement for Plasmid DNA Production
SAN DIEGO – February, 26, 2013 — Althea Technologies, Inc., a leading provider of biopharmaceutical development and manufacturing services, and Profectus BioSciences Inc, a technology based vaccine company, today announced the signing of a manufacturing supply agreement for plasmid DNA production. Under the agreement, Althea will provide gram-scale quantities of cGMP (current Good Manufacturing Practice) manufactured plasmid DNA expressing IL-12 to assist Profectus Biosciences’ ongoing DNA vaccine development efforts, which are supported by a contract from the National Institutes of Health. IL-12 helps prompt an immune response once the DNA enters a cell, which is part of Profectus Bioscience’s technology platform designed to overcome the poor delivery and immunogenicity of many DNA vaccines.
“Profectus is very pleased to establish this partnership with Althea for the production of the clinical grade plasmids for our DNA vaccine programs,” said John Eldridge, Chief Scientific Officer of Profectus BioSciences. “Althea provides an unmatched combination of state-of-the-art facilities and expertise in this area and we anticipate a long and productive association.”
“We are delighted to be awarded this contract, this project has tremendous potential for treating some of the world’s most devastating and challenging diseases” stated Rick Hancock, President and CEO of Althea Technologies. “By establishing this partnership, Althea will be able to leverage our plasmid manufacturing expertise to help advance this DNA vaccines program through the clinic and to the patients who need it.”
ABOUT ALTHEA TECHNOLOGIES, INC. Althea Technologies is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing. Althea’s formulation technology platform includes Crystalomics®, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations.
ABOUT PROFECTUS BIOSCIENCES Profectus BioSciences, Inc. is a technology based vaccine company devoted to the treatment and prevention of infectious diseases and related cancers, with the goal of reducing morbidity and mortality. Since its inception in 2003, the Company’s strategic intent has been to acquire and develop the technologies needed to achieve this goal. The Company has licensed a group of vaccine‐based technologies from Wyeth Vaccines (now Pfizer, Inc.) that greatly enhance the immunogenicity of prophylactic and therapeutic vaccines based on a “prime‐boost” strategy. This strategy uses the delivery of a best‐in‐class pDNA vaccine to “prime” the immune system, followed by a first-in‐ class “boost” with an rVSV vector. Current disease and virus targets include hepatitis C virus (HCV), human papilloma virus (HPV), herpes simplex virus type 2 (HSV‐2), human immunodeficiency virus (HIV), Ebola virus, Marburg Virus, the arenaviruses and malaria. The Profectus HIV DNA vaccine program has been supported through the award of a $32 M HIV Vaccine Design and Development Teams (HVDDT) contract (HHSN272200800062C) from the NIH that has supported 60% of the research, development, and manufacturing costs of the multi-antigen HIV vaccine and GENEVAX™ IL-12 programs, while the remainder of the cost has been provided through a contribution-in-kind. Partners and collaborators include Ichor Medical Systems, the Galveston National Laboratory, Yale University, the Institute of Human Virology, the Center for HIV/AIDS Vaccine Immunology, the National Cancer Institute, the NIH Division of AIDS, the Bill and Melinda Gates Foundation, the International AIDS Vaccine Initiative, the PATH Malaria Vaccine Initiative, the HIV Vaccines Trials Network, and the AIDS Clinical Trials Group. More information is available at www.ProfectusBioSciences.com