AlphaVax Product Overview
A primary focus at AlphaVax is the commercial potential of its alphavaccine vector technology in cancer immunotherapy, and the development of immunotherapeutic alphavaccines for the treatment of cancer is an area in which AlphaVax seeks a leading position in new treatment modalities.
AlphaVax has successfully optimized the alphavaccine technology, developed a strategic intellectual property portfolio, and a robust, scalable manufacturing process, and has advanced seven alphavaccine candidates into ten completed human clinical trials. The vaccine vector platform has demonstrated a favorable safety profile while eliciting the desired vaccine-specific immune responses.
Our vaccine development team successfully brought together its collective experience in process development, analytical methods, regulatory affairs, compliance, technology transfer, and manufacturing.
In addition, the technology is commercially available in vaccines for the veterinary market - based upon our RNA particle technology - and include products for PEDv, swine epidemic diarrhea, influenza, and rotavirus. Most of the development of veterinary and companion animalvaccines is today conducted by Merck's Animal Health's subsidiary, Intervet.
Pipeline
â– Completed | ■In planning/UnderwayÂ
Program | Pre-clinical | GMP | Phase I or I/II | Phase II |
---|---|---|---|---|
Cancer Immunotherapy | ||||
CEA(gastrointestinal cancers) | ||||
Her2 (breast cancer) | ||||
TRP2 (melanoma) | ||||
VRP adjuvant technology | ||||
PSMA (prostate cancer) | ✔ | ✔ | ✔ | ○ |
Program | Pre-clinical | GMP | Phase I or I/II | Phase II |
---|---|---|---|---|
Infectious Disease | ||||
CMV | ||||
HIV - monovalent | ||||
HIV - multivalent | ||||
Influenza - young adults, elderly | ||||
Pandemic Influenza - H1B & H5 | ||||
RSV | ||||
HSV-2 | ||||
SARS |
Program | Pre-clinical | GMP | Phase I or I/II | Phase II |
---|---|---|---|---|
Biodefence | ||||
Botulinum Toxin | ||||
VEE/EEE/WEE | ||||
Filovirus | ||||
Smallpox |
AlphaVax Cancer Treatments
Summary of Leading Programs
The commercial potential of its alphavaccine system in cancer immunotherapy is one of AlphaVax's primary areas of focus. Promising safety and immunogenicity results from the Company's first batch of Phase I clinical studies included four different alphavaccines,
Clinical testing of the Company's RNA particle alphavaccines for the immunotherapeutic treatments of colon cancer and breast cancer has produced encouraging safety and immunogenicity results, as well as signals related to survival and the breaking of tolerance.
Our alphavaccine for treating CEA expressing colon cancer indicated that (i) the vaccine was able to "break self-tolerance" and (ii) led to a trend for enhanced survival in patients in a high-dose cohort -- with measurable T cell responses.
Evaluation of the CEA alphavaccine in earlier stage III colon cancer patients elicited clinically relevant CEA-specific immune responses of greater magnitude and frequency than those measured in the Stage IV patients. Positive T-cell responses and antibodies against CEA have been seen.
The summary data showed a 5-year survival rate of 17% in Stage IV cancer and 100% in Stage III, with a relapse-free rate in the latter group of 75%. CEA-specific humoral immunity was seen in all patients. The CD8+ effector memory T cell to Treg ratio was also raised.
AlphaVax's HER2 alphavaccine for breast cancer patients with HER2-expressing tumors led to the induction of HER2-specific immunity and the enhancement of systemic immunity.
In collaboration with Memorial Sloan-Kettering Cancer Center (MSK), studies identified a potent therapeutic VRP vaccine encoding the melanoma differentiation antigen TRP-2. Treatment with this TRP2 VRP vaccine demonstrated durable anti-tumor effects. It was noted, from comparative studies in the murine model, that the RNA particle alphavaccine platform appeared to be superior to all others previously tested. A combination of immunomodulatory monoclonal antibodies and our vaccine candidate pointed to an increase in both immunogenicity and efficacy.