WASHINGTON DC, May 2 /PRNewswire-FirstCall/ -- The recent notification by the U.S. Department of Health and Human Services(HHS) of their intent to acquire Bavarian Nordic's Imvamune(R) smallpox vaccine will play a major role in the development of the company's pipeline and related strategic activities. This is due to the fact that the company's smallpox vaccine is also the recombinant vector technology for the development of vaccines against other diseases. A number of clinical trials against cancer, HIV and smallpox are underway or due to start in the U.S.
The intent by HHS to procure 20 million doses of a new smallpox vaccine is based on the Modified Vaccinia Ankara (MVA) virus which does not replicate in human cells and is expected to be safe for those who are immune-compromised.
Bavarian Nordic's next generation smallpox vaccine (Imvamune(R)) is based on a patented strain of MVA, known as MVA-BN(R). In addition to being the vaccine vector technology, Bavarian Nordic scientists have also demonstrated that MVA-BN(R). displays unique characteristics indicating broader applications in therapeutic or prophylactic immunotherapy.
While the company's MVA-BN(R)-based vaccine pipeline will benefit from the experience and results achieved in the Imvamune(R) clinical development program, a number of vaccine candidates are already in clinical trials in the U.S. or announced to begin shortly.
Biodefense
In its new medical countermeasure plan, HHS acknowledges that it "is well-advanced in the pre-award stage of an MVA vaccine acquisition program". This latest notification to Bavarian Nordic continues the long-standing collaboration between the company and the National Institutes of Allergy and Infectious Diseases (NIAID). Since 2003, the government has expedited a program to develop and manufacture a safe smallpox vaccine for the estimated 25% of the population who are immune-compromised and contra-indicated to current smallpox vaccines. At present, Bavarian Nordic's clinical program consists of 10 completed or on-going trials where more than 1,500 people have been vaccinated with Imvamune(R).
Three of the ongoing Phase II trials will be pivotal for an application of Emergency Use Authorization and registration of Imvamune(R) in the U.S. Two of these trials are being conducted in the U.S.: one in persons with HIV-infection and the other in people diagnosed with atopic dermatitis, both of which are categorized as immune-compromised.
Cancer
BN ImmunoTherapeutics, the company's U.S. subsidiary, has begun enrolment in two Phase I/II studies with its breast cancer vaccine candidate (MVA-BN(R)-HER2).
Reiner Laus, MD, President & CEO of BN ImmunoTherapeutics said: "We are excited about the potential of our vaccine candidate for treatment of women with breast cancer. Moving into Phase I is an important achievement in this program as well as in the development of our portfolio of vaccine candidates for the treatment of major cancers."
BN ImmunoTherapeutics plans to initiate a Phase I trial with its vaccine candidate against prostate cancer later this year.
HIV/AIDS
Bavarian Nordic's MVA-BN(R) polytope vaccine candidate against HIV will begin Phase I testing in the U.S. in combination with another HIV vaccine developed by the Danish company Pharmexa. The associated clinical trial will be conducted by the HIV Vaccine Trials Network (HVTN), which is supported with a cooperative agreement from NIAID. In addition to this trial, the company continues to generate data on the safety of MVA-BN(R) in persons with HIV infection from its Imvamune(R) clinical development program.
Need for a Safe "Next Generation" Smallpox Vaccine
The only means to prevent smallpox infection is through vaccination. The vaccinia virus found in traditional smallpox vaccines used and/or stockpiled today, are live, replicating viruses which can pose serious side-effects and lead to complications for persons with weakened or impaired immune systems. Accordingly, traditional smallpox vaccines are contra-indicated for those known as immune-compromised, such as people with active or a history of atopic dermatitis, HIV-infection, pregnant women, young children, the elderly, some cancer patients, and organ transplant recipients.
Imvamune(R) Smallpox Vaccine Development Program
Bavarian Nordic is developing Imvamune(R) as a stand-alone third-generation smallpox vaccine. While the company's goal is to register Imvamune(R) as a safe smallpox vaccine for all, the first step in this process is to obtain an Emergency Use Authorization (EUA) for Imvamune(R)
Bavarian Nordic's development program started in 1999 and since 2003 the company has collaborated with the NIAID on the expedited clinical development of Imvamune(R) under a progressive RFP program. Data from clinical trials with Imvamune(R) in more than 1,500 human subjects (healthy subjects, persons with atopic dermatitis and HIV-infection) have shown the vaccine candidate to be safe and well-tolerated. In addition, company studies have demonstrated that Imvamune(R) generates a rapid immune response against smallpox-like viruses in animals which is the only accepted means of proving efficacy for U.S. Food and Drug Administration (FDA) standards.
Cancer Immunotherapy
Statistics from the U.S. Centers for Disease Protection and Control (CDC) list cancer as the second leading cause of death in the United States. Of all cancers, breast cancer is the most common found in women and prostate cancer the most common found in men.
The concept of cancer immunotherapy is to stimulate the immune system to reject and destroy tumors. One of the most recognized treatments is the use of monoclonal antibodies which attack the proteins in or around a cancer cell. Known as passive immunotherapy, these antibodies induce a humoral response in the immune system. However, new research suggests that a cellular response must also be actively stimulated and maintained by the immune system in order to control cancer. Known as active immunotherapy, vaccination is one such approach. Viral vector-based vaccines in particular are under evaluation because of their known ability to induce both a strong humoral and a cellular immune response.
BN ImmunoTherapeutics' cancer immunotherapy strategy is to activate both a humoral and a cellular immune response in the body using MVA-BN(R) as its viral vector in vaccine development.
HIV Vaccines
According to the World Health Organization (WHO), approximately 40 million people are living with HIV, of which almost 3 million people die every year from AIDS-related complications. It is estimated that approximately 4 million people are infected with HIV each year.
Estimates from HIV research organizations suggest that an effective prophylactic HIV vaccine could prevent between almost 30-70 million of the 150 million new infections projected in the coming decades. A therapeutic vaccine would not prevent HIV but help prolong life in those already infected by helping to control the virus and thereby minimize the need for antiretroviral drugs.
Bavarian Nordic is pursuing a three-path strategy in the development of therapeutic and prophylactic HIV vaccines. Two of the company's HIV vaccine programs are in Phase II clinical development.
About Bavarian Nordic
Bavarian Nordic, headquartered in Denmark, is a leading international biopharmaceutical company developing and producing innoÂÂvative vaccines to prevent and treat infectious diseases and cancer.
In the U.S., Bavarian Nordic operates subsidiary companies, BN ImmunoTherapeutics, in Mountain View, California developing vaccines against cancers, and Bavarian Nordic Inc. in Washington, D.C. focused on business development, marketing, and government relations for the Bavarian Nordic Group. For more information on Bavarian Nordic visit: www.bavarian-nordic.com
"Safe Harbour" Statement under the Private Securities Litigation Reform Act of 1995": Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. No "forward-looking statement" can be guaranteed, and actual results may differ materially from those projected. Bavarian Nordic undertakes no obligation to publicly update any "forward-looking statement", whether as a result of new information, future events, or otherwise. Additional information regarding risks and uncertainties is set forth in the current Annual Report and in Bavarian Nordic's periodic reports, if any, which we incorporate by reference.
Bavarian Nordic A/SCONTACT: Contact: Elizabeth Dempsey Becker, Bavarian Nordic, Inc.,+1-(202)-536-1576, Ken Arnold, T Dean Reed Company, +1-(202)-223-3532
