Novavax Initiates Clinical Trial of Seasonal Influenza VLP Vaccine Candidate
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Date: Fri, 16 Apr 2010 Time: 5:10 PM
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Novavax, Inc. (Nasdaq: NVAX) is all set to develop a virus-like particle (VLP) based seasonal influenza vaccine. In a forward looking statement the company announced that it has initiated Phase II clinical trials under which healthy volunteers are being vaccinated. The Phase IIa randomized, placebo controlled clinical trials are being conducted to evaluate the safety and immunogenicity of different doses of its season influenza VLP vaccine.
Novavax is Rockville, Maryland based company that creates novel vaccines for infectious diseases using proprietary VLP technology. A few days ago Novavax had announced favorable results from the second stage of the Phase I/IIa human clinical trial of its pandemic influenza virus-like particle (VLP) vaccine candidate. Novavax's pandemic influenza VLP candidate is directed against the H5N1 A/Indonesia/05/2005 avian influenza strain.
Offering details of its ambitious clinical trials, the company’s statement stated specifically, the vaccine will be studied in approximately 300 healthy adults between the ages of 18 to 49 years, who will receive a single injection of either a placebo or an influenza vaccine at doses of 5 mcg, 15 mcg or 30 mcg. The goals of the study are to choose a dose for evaluation in a subsequent Phase III efficacy study and to continue the evaluation of safety of its novel influenza VLP vaccines.
The VLPs are recombinant structures that mimic the size and shape of a virus but lack genetic material and are therefore incapable of replication. Because they resemble actual infectious particles presenting proteins in the same conformation as on the wild-type virus, they are able to induce potent immune responses.
Novavax’s VLP Based Seasonal Influenza Vaccine Advantages
The new seasonal influenza VLP vaccine candidate is differentiated from the existing influenza vaccines in several ways. First, it includes three viral proteins (incorporated in the vaccine as three separate VLPs) important for inducing a broad immune response including two surface proteins, hemmaglutinin ("HA") and neuraminidase ("NA"), and a core matrix protein, M1. In contrast, most seasonal vaccines consist almost entirely of HA with little or no NA and M1. The HA protein induces antibody that neutralizes or blocks the growth of the virus; NA induces antibodies that prevent cell-to-cell transmission of virus down the respiratory tract, potentially reducing the severity of influenza disease; and cell mediated immune responses to M1 may lead to destruction of cells already infected. Besides, the vaccine is made in cell culture rather than eggs, which permits an exact genetic match to the flu strains causing illness since there is no requirement for adapting the vaccine to grow in eggs.
Another significant advantage of the vaccine is that the Novavax's manufacturing process makes it possible to rapidly produce a vaccine that contains strains that are an exact genetic match to the strains circulating in the community causing influenza disease. Novavax's influenza VLPs are produced through recombinant technology in insect cell culture, utilizing a manufacturing process that will consist entirely of disposable, ready-to-use equipment. Current yields are 7 to 10 times higher than those of traditional egg-based or mammalian cell culture manufacturing. Because the Novavax process involves recombinant technology and does not require a live influenza virus, a matched vaccine for the first seasonal influenza clinical trial was manufactured within 12 weeks of identification of the Centers for Disease Control and Prevention ("CDC") released seasonal strains, or approximately half the time required to manufacture egg-based vaccines. The ability to rapidly respond to the identification of annual seasonal strains may be important in providing timely vaccine in advance of annual physicals for children before the school year.
Showing confidence in the vaccine candidate, Dr Rahul Singhvi, President and CEO of Novavax said, "VLPs are a very promising approach against influenza as we recently demonstrated with the announcement of favorable results in a Phase IIa human clinical trial of our VLP based pandemic influenza vaccine.” Dr Singhvi also stated Novavax has unique advantages as it gain synergies from the development of VLP pandemic and seasonal influenza vaccines. “For example, since both vaccines utilize the same manufacturing approach, safety information from either one of these influenza vaccine programs would compliment and support the other program which should reduce the overall development timeline for each program," Dr Singhvi added.
Seasonal Influenza
Seasonal influenza is seen as a serious medical problem in US. The CDC reports that 15 to 60 million people in the U.S. contract influenza each year. While the majority of individuals with influenza recover in less than two weeks some may develop life-threatening complications such as pneumonia. In addition, influenza exacerbates the symptoms of chronic health conditions such as diabetes, asthma and congestive heart failure. The most severe disease occurs in infants and young children and adults older than 65 years of age. According to a statistical study, Influenza leads to over 200,000 hospitalizations and 36,000 deaths.
The Advisory Committee on Immunization Practices ("ACIP"), which has been expanding recommendations for seasonal influenza vaccination for the last several years, currently recommends seasonal influenza vaccination for children 6 months through 18 years of age, pregnant women, adults over 50 years of age, and individuals of any age with chronic health conditions or who are at high risk of influenza disease. Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013.
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