Partnered Programs
We have established significant relationships with pharmaceutical companies and public agencies.
These relationships have allowed us to advance our technology development and manufacturing process
in-house, as well as to expand the alphavaccine product pipeline through partnered programs.
Our corporate partnering strategy involves licensing the alphavaccine platform to major vaccine companies
and biotech firms for either disease-specific or antigen-specific product applications. The integrated
vector design and development, manufacturing, and clinical and regulatory experience that we are building
around the platform also brings significant value to partnerships, allowing our licensees to reach the
clinic efficiently with each new product candidate.
Our partners and collaborators include:
Novartis Vaccines and Diagnostics
We have entered into an agreement with Novartis Vaccines and Diagnostics, through which they have acquired
exclusive rights to our CMV vaccine for an upfront payment of USD 20 million. In addition Novartis has an
option to make an equity investment at the end of phase II clinical trials for the purchase of 4 million
AlphaVax shares. Under the terms of the agreement AlphaVax will be eligible for milestones and royalties.
AlphaVax will provide the clinical trial material for the phase II trials. Novartis will be responsible for
the development of the CMV program for phase II clinical trials onwards as well as for registration and
world-wide commercialization. The CMV vaccine candidate is an alphavaccine expressing CMV phosphoprotein
65, IE1 (immediate early protein 1) and gB glycoprotein.
Progenics Pharmaceuticals, Inc.
We have granted an exclusive license to Progenics Pharmaceuticals, Inc. to develop an alphavaccine product
expressing PSMA (prostate specific membrane antigen), an antigen that is over-expressed in prostate and other
cancers. Progenics plans to initiate clinical testing in 2009.
Duke University
Researchers at the Duke Comprehensive Cancer Center and AlphaVax are co-investigators on two cancer vaccine
development grants from the National Cancer Institute and the Department of Defense, Breast Cancer Research
Program. The colon cancer vaccine is currently being evaluated in a phase I/II clinical trial funded by the
National Cancer Institute. A breast cancer vaccine is scheduled to enter a phase I/II clinical trial in
4Q2009 which is funded by the Department of Defense.
National Institutes of Health
AlphaVax has been the recipient of eight grants from the National Institutes of Health (NIH) National Institute
of Allergy and Infectious Disease (NIAID). These awards have included support for research on vaccines for
influenza,
SARS, and
biodefense
targets.
Since mid-2002, our HIV program has been supported by the NIH, first through a cooperative research grant and
then through a vaccine design and development contract. Through NIH's Division of AIDS Vaccine Research and
Prevention Program, these funds have supported preclinical design, research and testing of vaccine candidates.
The NIH's Vaccine Trial Network (VTN) has completed one clinical trial using a single-gene "prototype" alphavaccine,
and a multigene vaccine candidate is being manufactured in the first half of 2009 for possible future testing by
the VTN. The positive safety and immunogenicity results from the first Phase I trial of the prototype HIV vaccine
candidate were presented in 2006.
United States Army Medical Research Institute of Infectious Diseases (USAMRIID)
AlphaVax are co-investigators with researchers at USAMRIID Fort Detrick on four grants to develop vaccine
candidates for specific biodefense targets: Marburg virus (a filovirus), botulinum neurotoxin, smallpox,
and encephalitis viruses.