A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe. The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and "remember" it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters.
Vaccines can be prophylactic (e.g. to prevent or ameliorate the effects of a future infection by any natural or "wild" pathogen), or therapeutic (e.g. vaccines against cancer). In this article I will feature three vaccine companies with near term catalysts.
1. Novavax (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle and recombinant nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces novel vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field.
The company gave the latest update on the upcoming milestones on August 14 at Wedbush 2012 Life Sciences Conference:
In the last 6 months, the company has initiated three clinical trials, vaccinating more than 1,100 subjects. The company recently reported data from the seasonal influenza trial and expects to report data from two pandemic influenza trials within the next 90 days.
The company reported the second-quarter financial results on August 3 with the following highlights:
|Net loss||$5.9 million|
The company is expecting an annual cash burn rate of $16.5 million. With this cash burn rate the company would have enough cash into 2014.
The stock has a $4.5 price target from the Point and Figure chart. The stock has seen some insider buying this year. The last insider sell transaction was in August 2011. I believe the stock could reach $2.5-$3 range after positive data from the pandemic influenza trials within the next 90 days. If the results are negative the stock could dip below $1.5.
2. Celldex Therapeutics (CLDX) is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates.
Celldex expects to:
- Initiate a Phase II pilot study of CDX-1135 (formerly TP10) in dense deposit disease (DDD), an orphan kidney disease in children and young adults, in the second half of 2012. DDD is caused by uncontrolled activation of the alternative pathway of complement. The complement activation leads to progressive kidney damage and failure. CDX-1135 has been shown to inhibit the complement cascade at both the C3 and C5 levels and has shown clear biologic activity in DDD animal models and in earlier human clinical trials. Celldex believes CDX-1135 could have therapeutic applications in DDD and other complement mediated diseases. The study will determine the appropriate dose and regimen for further clinical development of CDX-1135 based on safety, tolerability, biological and therapeutic activity.
- Present results from Phase I study of CDX-1401 in solid tumors in the fourth quarter of 2012.
- Present updated overall survival data from the rindopepimut Phase II ACT III study in the fourth quarter of 2012.
- Present more mature data from the EMERGE Phase IIb study in the fourth quarter of 2012.
- Complete Phase I accrual of the CDX-301 healthy volunteer study in the fourth quarter of 2012. Celldex plans to develop CDX-301 for hematopoietic stem cell transplant.
- Complete Phase I accrual of the solid tumor arm of the CDX-1127 study in the fourth quarter of 2012.
The company reported the second-quarter financial results on August 10 with the following highlights:
|Net loss||$13.8 million|
At June 30, 2012, Celldex reported cash, cash equivalents and marketable securities of $78.7 million, which the company believes will be sufficient to meet estimated working capital requirements and fund planned program development into 2014.
The stock has a $11.75 price target from the Point and Figure chart. The stock has seen only insider buying since November 2009. The last insider sell transaction was in January 2009. The company is expecting to present clinical data from three different trials in the fourth quarter 2012. If all the data is positive we could see the stock trade in the range of $7-$10.
3. Inovio (INO) is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown in humans to generate best-in-class immune responses with a favorable safety profile. Inovio's clinical programs include Phase II studies for cervical dysplasia, leukemia and hepatitis C virus and Phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck (MRK), ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, U.S. Dept. of Homeland Security and PATH Malaria Vaccine Initiative.
- Enrollment is ongoing in Inovio's Phase II clinical study of VGX-3100 for cervical dysplasia. Data is expected in the second half of 2013.
- Two Inovio collaborators, the University of Southampton and ChronTech Pharma AB, are expected to report interim data from their Phase II studies of DNA vaccines for leukemia and hepatitis C virus, respectively, before year end.
- Inovio is advancing discussions with large pharmaceutical companies with the goal of securing new partnerships to advance the development and commercialization of its SynCon vaccines.
The company reported the second-quarter financial results on August 9 with the following highlights:
|Net loss||$4.1 million|
Based on management's projections and analysis, the company believes that current cash and cash equivalents plus short-term investments are sufficient to meet its planned working capital requirements into the third quarter of 2013.
The stock has seen only insider buying this year with the latest transaction in August 2012. The company is anticipating data from three different trials later this year. I believe the stock could trade in the range of $0.80 - $1.00 with positive data from these three trials. If we get negative data from these trials the stock could drop below $0.40.