EPALINGES, SWITZERLAND--(Marketwire - Aug. 21, 2012) - Mymetics Corporation (OTCQB:MYMX), a leader in the development of mucosal and virosomal-based vaccines for infectious diseases, announced today the strategic decision to select its respiratory synctitial virus (RSV) vaccine candidate as the lead program from its proprietary second generation virosome platform. The RSV vaccine candidate has demonstrated an encouraging pre-clinical efficacy and safety profile as reported in PloS One (T. Kamphuis, T. Meijerhof, T. Stegmann et al., May 2012, e36812). RSV represents a major unmet clinical need in both the elderly and pediatric populations.
Mymetics' RSV vaccine candidate is based on its innovative and proprietary second generation virosome platform along with an approved adjuvant incorporated into the viral membrane to stimulate a balanced immune response. The vaccine, composed of the natural RSV membrane containing the natural RSV antigens, but absent the infectious genetic material, generates a powerful immune response similar to a normal infection, but with the safety profile of a killed virus vaccination. The two critical hurdles to successfully developing an RSV vaccine are to generate not only neutralizing antibody responses that mimic native viral proteins, but also a balanced TH-1 oriented immune response. The Mymetics RSV candidate, by virtue of its inherent design and the incorporation of a TLR-4-directed adjuvant, has the potential to meet these two critical requirements.
The pre-clinical proof-of-concept results for Mymetics' RSV vaccine candidate will also be presented at the 8th Annual RSV Symposium held from September 27th to 30th, 2012 in Santa Fe, New Mexico.
"We believe our RSV vaccine candidate is a best-in-class construct with blockbuster potential that we anticipate will be the first of many novel vaccine constructs that can be generated from our proprietary 2nd generation virosome platform," commented Mymetics' President and CEO, Grant Pickering. "We look forward to expeditiously advancing this program into the clinic with the support of our new team of strategic RSV clinical and regulatory experts who join Toon Stegmann, our CSO and the inventor of the virosome technology platform, and Dr. Stanley Plotkin, a renowned vaccinologist and the chairman of our scientific advisory board."
In coincidence with the RSV program update, Mymetics has announced the recent appointment of three strategic RSV consultants and advisors to facilitate the advancement of its pipeline of vaccine candidates: Dr.'s George Kemble, Tom Monath and Bogdan Dziurzynski.
Dr. George Kemble has been appointed to the Scientific Advisory Board of Mymetics. Dr. Kemble is currently the CSO at 3-V Biosciences, a biotech company with a unique approach to antiviral drug discovery and development. Prior to 3-V, Dr. Kemble was the Senior Vice President of R&D at MedImmune and Head of Research at MedImmune. He is a leading authority on vaccine development and in particular the development of vaccines for RSV. Dr. Kemble was responsible for the research and development of multiple products, including the successful launch of FluMist®. Dr. Kemble began his research career as a staff scientist at Aviron, which was later acquired by MedImmune. Dr. Kemble received a BS from the University of Santa Clara and a PhD from Stanford University and did his post-doctoral training at UCSF.
"I am pleased to join the Mymetics team at such an important time for the company. Utilizing the native RSV virus, in the form of a virosome, to yield a potentially preventative vaccine for RSV is promising and could be an important breakthrough to address this critical unmet medical need," commented Dr. Kemble on his appointment.
Dr. Thomas Monath has joined Mymetics as consulting Chief Medical Officer. Dr. Monath has devoted his nearly 30-year career to the fight against infectious disease through his work in the military, corporate, academic and investment sectors.
Dr. Bogdan Dziurzynski has been retained as Strategic Regulatory consultant for Mymetics. Dr. Dziurzynski currently serves as a strategic regulatory management consultant to the biotechnology industry and serves on the Board of Directors of Dendreon Corporation and the Biologics Consulting Group, Inc.
About RSV Disease
Respiratory Syncytial Virus (RSV) annually causes an epidemic of respiratory tract infections in patients of all ages, infecting an average of 64 million people and killing 160,000 worldwide. It has a high prevalence in developed countries, affecting those with weak immune systems. It is a major cause of lower respiratory tract infection during infancy, and of life-threatening pulmonary disease among elderly patients. RSV is highly contagious and can be spread through droplets containing the virus when someone coughs or sneezes. Currently, there is no prophylactic vaccine against RSV.
Mymetics Corporation is a public (OTCQB:MYMX) vaccine company developing virosome-based preventative vaccines for infectious diseases, including its proprietary second generation platform. Mymetics' core technology and expertise are in the use of virosomes, lipid-based carriers containing functional fusion viral proteins with the ability to be combined with rationally designed antigens and/or adjuvants to yield vaccine constructs that confer a powerful immune response similar to normal infection yet with the safety of killed virus vaccination. The company's vaccines are designed to induce protection against early transmission and infection, focusing on the mucosal immune response as a first-line defense, which for many pathogens will be essential for the development of an effective prophylactic vaccine. The lead vaccine candidate from the 2nd generation platform is targeting RSV, a ubiquitous viral pathogen that causes substantial morbidity and mortality in the elderly and pediatric populations. The Mymetics pipeline also includes vaccines to prevent influenza (intranasally administered), HIV-1 and malaria that have each completed Phase I clinical proof-of-concept studies. For further information, please visit www.mymetics.com.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements, which are identified by the words "believe," "expect," "anticipate," "intend," "plan" and similar expressions. The statements contained herein which are not based on historical facts are forward-looking statements that involve known and unknown risks and uncertainties that could significantly affect our actual results, performance or achievements in the future and, accordingly, such actual results, performance or achievements may materially differ from those expressed or implied in any forward-looking statements made by or on our behalf. These risks and uncertainties include, but are not limited to, risks associated with our ability to successfully develop and protect our intellectual property, our ability to successfully develop our vaccine candidates, our ability to raise additional capital to fund future operations and compliance with applicable laws and changes in such laws and the administration of such laws. See Mymetics' most recent Form 10-K for a discussion of such risks, uncertainties and other factors. Readers are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date the statements were made.