MALVERN, Penn.—Drug delivery specialist Novavax announced it entered into a collaborative agreement with the University of Pittsburgh School of Medicine's Dr. Ted Ross to evaluate the efficacy of the company's virus-like particle (VLP) influenza vaccines and its Novasome delivery adjuvant. The collaboration is a renewal of sorts of a long-term working relationship between Ross and Novavax's vice president of vaccine research Dr. Rick Bright from their days at Emory University and the CDC, respectively.
Under the terms of the collaboration, Ross's group will evaluate the full range of immunity elicited by the VLPs both on their own and when used in conjunction with Novasomes, non-phospholipid liposomal carriers. The researchers will vaccinate mice with VLPs and monitor the immune responses. They will then test the mice for their response to identical and related strains of influenza.
According to Bright, the collaboration is part of an effort by Novavax to return to its vaccine roots. "Novavax has been developing and producing VLP vaccines as a contract service for others while the major focus of the company was on the development of micellular nanoparticle-based drugs for transdermal delivery, such as Estrasorb," he says.
"Once the major drug product was launched and Dr. Rahul Singhvi was appointed as the CEO, the company made a major shift back into the vaccine area, this time focusing on developing proprietary VLP vaccines for influenza and HIV, as well as developing a proprietary adjuvant called a Novasome."
The collaboration comes at a time when there has been increased rhetoric about an impending influenza pandemic and the global impact of the H5N1 bird flu. "Even if the current bird flu strains never recombine with current seasonal influenza, a pandemic influenza will eventually develop," Ross says. "In the last century, there have been three pandemic influenza seasons that resulted in millions of worldwide deaths. The ability to develop vaccines quickly to combat an emerging pandemic is highly desirable."
As Ross explains, VLPs offer advantages over more traditional peptide vaccines as the human body is more highly attuned to particulate antigens, which leads to a stronger immune response. "VLPs are non-infectious, genomeless particles that look like natural viruses and therefore are recognized by our immune system with similar efficiency as natural viruses, but without the potential to cause infection, such as live influenza vaccines or revert to an infectious form, such as attenuated particles or incompletely killed particles," he adds.
Speed-of-production is also a key factor in VLP vaccines, Bright adds. "By using a highly productive baculovirus system to produce VLPs in insect cells, we see a significant increase in the yield of vaccine that can be made compared to any other vaccine manufacturing approach," he explains. "Novavax is unique in that we use a completely disposable, portable manufacturing system developed by Wave Biotech to produce our VLPs in large-scale capacity."
"We can respond with first doses of a pandemic influenza vaccine in 60 days, whereas it would take egg- or cell-based technologies nine months," he continues. "This is a critical factor when people are dying at an alarming rate due to the horrible spread of avian influenza."
Novavax is currently completing preclinical trials for pandemic and seasonal influenza vaccines to complete the IND package it will present to the FDA this summer. Says Bright: "We plan to begin our clinical trials for the H5N1 clade-2 pandemic influenza vaccine this fall."
