Vical: A Biotech Flying Under the Radar
3 comments | April 06, 2011 | about: AMGN, BMY, DNDN, GSK, VICL
Vical (VICL) is one of those biotechnology companies that seems to fly under almost everyone’s radar. Selling for around $3.00 per share, the company focuses on vaccines and gene therapies, fields in which there already exists strong competition. But what excites those who have found this undiscovered gem are VICL’s unique approaches to DNA vaccines and non-viral gene therapy. As well, its pipeline, both in terms of independent programs and corporate collaborations as well as U.S. government collaborations, speaks to a promising future.
VICL’s DNA technology is based on plasmid DNA (pDNA), closed loops of DNA that encode any protein of interest. When injected into the body, our cells take up the pDNA and produce the encoded protein. Importantly, the pDNA can be used to produce infectious disease vaccines, cancer vaccines, or immunotherapeutics. The technology not only facilitates faster development and production time, but also yields products that are free from viral components that may cause unwanted immune responses or infections. For example, our annual flu vaccine is typically made using eggs to incubate the vaccine. People with egg allergies cannot be given such vaccines, and so, without alternative treatments, remain susceptible to the flu. The available of flu vaccines produced using VICL’s DNA technology would solve this problem. Also important is the fact that the corporation continues to develop new formulations and delivery technologies, including the use of lipid molecules that can function as vaccine adjuvants.
Perhaps the program of most interest to the Street now involves the Phase 3 trials of Vical’s Allovectin-7 for Stage III and IV melanoma. This drug, developed independently by the corporation, is described by Vical as "a first-in-class DNA-based immunotherapeutic designed to stimulate both innate and adaptive immune responses in local tumors and distal metastases.” The company recently completed full patient (390) enrollment with sites primarily in the U.S. and Europe. According to VICL: “The trial design was accepted by FDA under a Special Protocol Assessment (SPA). Additionally, Allovectin’s mechanisms of action are applicable to any type of accessible, immunoreactive solid tumor, providing multiple follow-on indications, such as breast cancer, prostate cancer, and head and neck cancer. Vical has obtained orphan drug and fast track designations in the U.S. and is seeking a commercialization partner for all the major markets in North America and Europe."
In February, 2011, the corporation announced that it expects to complete patient follow-up and lock the Phase 3 clinical trial database in the second half of 2011. According to the news release, "published results from a completed Phase 2 trial of Allovectin-7 in 127 chemo-refractory or chemo-intolerant patients with metastatic melanoma compare favorably with historical controls from other studies. Among the 15 responders (11.8%), four had complete responses and 11 had partial responses. The median duration of response was 13.8 months, and all responses were durable, lasting at least six months. The median survival for all patients was 18.8 months.” If approved, Allovectin-7 would compete with Bristol-Myers Squibb's (BMY) Ipilimumab, the second immunotherapy in oncology to be approved within a year. (On April 29, 2010, the FDA approved the very first active immunotherapy for the treatment of cancer – Dendreon Corporation’s (DNDN) Provenge (sipuleucel-T) for metastatic castrate-resistant prostate cancer (CRPC). Other companies working in the crowded field include Amgen (AMGN), AVAX, and GlaxoSmithKline (GSK), and failures are not uncommon (see, for example, this article), given the severity of the disease. To say that investors in VICL await with eagerness the results of the Phase 3 data is an understatement.
Also developed independently by the corporation is the TransVax therapeutic cytomeglovirus (CMV) vaccine. This DNA vaccine prevents reactivation of latent CMV or the introduction of the virus through donor cells or tissues in transplant recipients. The drug is in Phase 2 testing, and VICL is seeking a commercial partner for all major markets.
One of the more exciting independent programs within VICL, and one that many people seem to overlook, is the corporation’s HSV-2 vaccine. Under a grant from the National Institute of Allergy and Infectious Diseases Division of the National Institutes of Health, the effort is directed at developing a plasmid DNA-based vaccine to inhibit recurring lesions in patients latently infected with herpes simplex virus type 2 (HSV-2). Now, there is no cure for genital herpes. It is a recurrent, lifelong viral infection. Of the two serotypes identified, HSV-1 and HSV-2, the latter is most common in the United States, with some 50 million persons in the U.S. infected. Each year, 1 million new cases are recorded. While still in the preclinical stage, results have shown a reproducible statistically significant reduction in viral lesion occurrence in guinea pigs latently infected with HSV-2.
Finally, among the other, many development programs underway at VICL is one with the U.S. Naval Medical Research Center (NMRC) to develop its platform technology for the rapid development and production of vaccines against emerging infectious diseases. Included is funding to support the development of a Vaxfectin-formulated DNA vaccine against H1N1 pandemic influenza, which is expected to complete Phase 1 testing in the first quarter of 2011. Vaxfectin, a potential universal adjuvant developed by VICL, has been shown in multiple animal models to significantly increase the antibody and T-cell immune responses to antigens expressed from plasmid DNA vaccines.
Vaxfectin has other uses, as well. For example, VICL is working in the area of pandemic influenza vaccines (H5N1 and H1N1) Its H5N1 DNA vaccines were advanced to clinical testing in two Phase 1 trials and were the first-in-human tests using the patented Vaxfectin adjuvant. The results of the Phase 1 trials indicated that Vaxfectin-formulated H5 plasmid DNA vaccines were well tolerated and elicited antibody responses in the range reported for conventional protein-based vaccines. Had VICL’s technology been approved when the Swine flu struck worldwide, it is likely that the United States would not have experienced a shortage of the vaccine.
The information is just a brief overview of this interesting but largely undiscovered biotech company. As always, do your own due diligence, beginning with a read of the company's results for 2010. I think you will be both surprised and impressed.
Disclosure: I am long VICL, DNDN. I will not alter my positions in VICL or DNDN within 24 hours of the time of publication of this article. |
