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 Concept | Intended Use | Development Status1 | Lead Developer |
| INDEPENDENT PROGRAMS | |||
|---|---|---|---|
| Allovectin-7® cancer immunotherapeutic | First-line treatment for metastatic melanoma | Phase 3 | Vical |
| TransVax™ therapeutic vaccine for cytomegalovirus | Prevent viral reactivation and disease after transplant | Phase 2 - enrollment complete | Vical |
| Prophylactic vaccine for H5N1 pandemic influenza virus | Protect against infection, disease, and/or viral shedding | Phase 1 completed | Vical |
| Prophylactic vaccine for H1N1 pandemic influenza virus | Protect against infection, disease, and/or viral shedding | Preclinical | Vical |
| CyMVectin™ prophylactic vaccine for cytomegalovirus | Prevent infection before and during pregnancy do preclude fetal transmission | Preclinical | Vical |
| Therapeutic vaccine for herpes simplex type 2 virus | Prevent recurring flare-ups to reduce viral shedding and transmission | Research | Vical |
| CORPORATE COLLABORATIONS | |||
| Collategene™ angiogenic therapy encoding Hepatocyte Growth Factor | Induce local growth of blood vessels to restore blood flow to limbs affected by ischemia | NDA filed in Japan; Phase 2 completed in the United States |
AnGes |
| Angiogenic therapy encoding Fibroblast Growth Factor 1 | Induce local growth of blood vessels to restore blood flow to limbs affected by ischemia | Phase 3 - enrollment complete | Sanofi-aventis |
| Angiogenic therapy encoding Hepatocyte Growth Factor | Induce local growth of blood vessels to restore blood flow to heart affected by ischemia | Phase 1 completed in the United States | AnGes |
| Therapeutic vaccine encoding carcinoembryonic antigen and human epidermal growth factor receptor 2 | Treat breast, colorectal, ovarian or non-small cell lung cancer | Phase 1 | Merck |
| Therapeutic vaccine encoding human telomerase reverse transcriptase | Treat non-small cell lung, breast or prostate cancer, melanoma, or carcinomas of the upper GI tract, colon, kidney, or bladder | Phase 1 | Merck |
| Prophylactic and/or therapeutic hepatitis C vaccine | Prevent and/or treat infection, disease, and/or viral shedding | Research | Merck |
| Apex-IHN® prophylactic vaccine for infectious hematopoietic necrosis virus | Protect farm-raised salmon from infection and disease when exposed to infected wild salmon | Marketed in Canada | Aqua Health (Novartis) |
| Therapeutic cancer vaccine encoding human tyrosinase | Adjunct treatment to increase survival time of dogs with oral melanoma | Conditional approval in the United States | Merial |
| GOVERNMENT COLLABORATIONS | |||
| Prophylactic and/or therapeutic HIV vaccine | Prevent and/or treat infection, disease, and/or viral shedding | Phase 2 | NIH |
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 (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.