PRODUCT DEVELOPMENT
We, together with our licensees and collaborators, are currently developing a number of DNA-based vaccines and therapeutics for the prevention or treatment of infectious diseases, cardiovascular diseases and cancer. The table below summarizes our independent programs and corporate and government collaborations.
| Product Description | Project Target/ Indication(s) | Development Status (1) | Primary Developer |
| INDEPENDENT PROGRAMS | |||
|---|---|---|---|
| Infectious disease vaccine | Cytomegalovirus | Phase 2 | Vical |
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Pandemic influenza | Phase 1 | Vical |
| Cancer immunotherapeutic | Allovectin-7®, metastatic melanoma | Phase 3 | Vical |
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IL-2/EP, metastatic melanoma | Phase 1 | Vical |
| CORPORATE COLLABORATIONS | |||
| Infectious disease vaccine | Hepatitis B virus | Research | Merck |
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Hepatitis C virus | Research | Merck |
| Tumor-associated antigen therapeutic vaccine | HER-2 and CEA; breast, colorectal, ovarian, or non-small cell lung cancer | Phase 1 | Merck |
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Unspecified cancer (2) | Research | Merck |
| Angiogenic growth factor | HGF, peripheral arterial disease | Phase 3 | AnGes / Daiichi Pharma |
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HGF, ischemic heart disease | Phase 1 | AnGes / Daiichi Pharma |
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FGF-1, peripheral arterial disease | Phase 3 | Sanofi-aventis |
| Preventive infectious disease vaccine (animal health) | Apex-IHN®, infectious hematopoietic necrosis virus in salmon | Marketed in Canada | Aqua Health |
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Various undisclosed (2) | Research | Merial |
| Therapeutic cancer vaccine (animal health) | Canine melanoma | Conditional approval in U.S. | Merial |
| GOVERNMENT COLLABORATIONS | |||
| Infectious disease vaccine | HIV | Phase 2 | NIH |
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Ebola virus | Phase 1 | NIH |
In addition to the above programs, the NIH has completed its Phase 1 studies in both West Nile virus, or WNV, and severe acute respiratory syndrome, or SARS. The NIH has transferred the IND for the SARS program to us and we are currently evaluating our options in continuing the development of a SARS vaccine. Due to the lack of commercial opportunities, neither we nor the NIH plan further development of a WNV vaccine at this time. Also, Merck recently announced that it had stopped its Phase 2 HIV vaccine trials based on adenovirus technology and that it will be analyzing data in the coming months before continuing its HIV vaccine effort.
(1) "Research" indicates exploration and/or evaluation of a potential product candidate in a nonclinical laboratory setting. "Preclinical" indicates that a specific product candidate in a nonclinical setting has shown functional activity that is relevant to a targeted medical need, and is undergoing toxicology testing in preparation for filing an Investigational New Drug, or IND, application. "Phase 1" clinical trials are typically conducted with a small number of patients or healthy subjects to evaluate safety, determine a safe dosage range, identify side effects, and, if possible, gain early evidence of effectiveness. "Phase 2" clinical trials are conducted with a larger group of patients to evaluate effectiveness of an investigational drug for a defined patient population, and to determine common short-term side effects and risks associated with the drug. "Phase 3" clinical trials involve large scale, multi-center, comparative trials that are conducted with patients afflicted with a target disease to evaluate the overall benefit-risk relationship of the investigational drug and to provide an adequate basis for product labeling. For life-threatening diseases, initial human testing generally is done in patients afflicted with the target disease rather than healthy subjects. These studies may provide results traditionally obtained in Phase 2 trials and are referred to as "Phase 1/2" trials.In some special cases where the efficacy testing of a product may present a special challenge to testing in humans, such as in the case of a vaccine to protect healthy humans from a life-threatening disease that is not a naturally occurring threat, effectiveness testing may be required in animals.
(2) Pursuant to our collaborative agreements, we are bound by confidentiality obligations to our collaborators that prevent us from publicly disclosing these targets and indications. Additionally, some project targets and indications cannot currently be disclosed because they have not yet been selected by our collaborators.