1. DNA Vaccines, a Fast and Efficient ‘Plug-N-Play’ Technology
Vical uses closed loops of DNA (called plasmids or pDNA) as a DNA delivery technology, useful for protein therapy, immuno-therapy, cancer vaccines, and infectious disease vaccines. DNA vaccines use portions of the genetic code of a pathogen to cause the host to produce proteins of the pathogen that may induce an immune response. Vical CEO Vijay Samant explains the technology is ‘plug-n-play’ : it is extremely fast, and requires only the sequence for a pathogen (not the actual pathogen).
2.Allovectin-7, a Phase 3 Cancer Immunotherapy for Head & Neck Tumors
Vical’s lead compound, Allovectin-7, is a Phase 3, cancer immunotherapeutic, first-line treatment for metastatic melanoma. For its phase 3 trial, Vical has selected patients with normal LDH levels, an intact immune system (chemonaive), and no brain or liver metastases. The primary endpoint secured in a Special Protocal Assessment (SPA) with the FDA is response rate at 6mo. The secondary endpoint is survival. The recent approval of Provenge, Dendrion’s prostate cancer vaccine, has helped buy-side investors look at cancer immunotherapy as a reality, and has paved the way with regulators. Allovectin-7 is partnered with Japanese company AnGes in Asia for Head & Neck solid tumors. AnGes is covering the cost of the Phase 3 trial. Vical has retained the US and EU rights. The next milestone expected for Allovectin-7 is a safety review, by year end.
3.TransVax, a Phase 2 DNA Vaccine to Prevent Cytomegalovirus (CMV) Reactivation
Cytomegalovirus (CMV) is a nasty little bug that comes from the herpes family. 80% of people are infected by age 40 in the US. CMV hides in a synergistic balance in the immune system. When the immune system is compromised, it attacks multiple organs and can be deadly. In the immuno-suppressive state, the trial is in bone marrow transplant, where TransVax vaccine teaches the immune system to control the CMV virus. The data for bone marrow could be applicable to liver and kidney, which are very large indications. The entire Phase 2 data for Transvax – a 12 month follow up showing safety, immune response, and virological endpoints – is expected in september. CMV is also one of the leading causes of birth defects and mental retardation from an infectious agent, for childbearing women. For Vical’s pre-clinical CyMVectin, the opportunity (in childbearing women) could be comparable to that of Merck’s Gardasil for HCV, explains Vijay Samant. Vijay expects successful Phase 1/2 proof of concepts to attract development and manufacturing partners, given the succes of infectious disease vaccines in Phase 3 trials.
4.Vical’s Speed and Adaptability Play on Pandemic Influenza Appeals to Department of Defense for Military Vaccines
During the swine flu pandemic, Vical was the first company to develop a vaccine, and to test it in animals. Vical’s technology doesn’t require a pathogen, only the genetic code. The speed of study and adaptability are advantages Vical has on larger companies that dominate the space, such as GSK. That is why Vical is working with the Department of Defense’s Technology Transformation Initiative on rapidly manufacturing large quantities of DNA vaccines.
5.Vical Licensors, Sanofi and Angios, in Phase 3 Trials on Multi-Billion Dollar PAD Market
Data on the two Phase 3 PAD trials run by Vical licensors is expected in in the second half of 2010. Peripheral Artery Disease (PAD) can cause blockages in arteries, pain in the legs, and for diabetics it can lead to ulcers and amputations. The results of these trials can provide technology validation and mid-single digit royalties in a multi-billion dollar market. We could also see the first gene therapy concept to come to fruition in these trials.
This interview was conducted at the NASDAQ Marketsite, on May 25th, 2010, in New York City.
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