Quebec City, QC – Biotech company Medicago says it has completed initial studies towards the development of a new VLP vaccine candidate for rabies. Over the past 12 months, it says it has been working to expand the application of its VLP technology to new vaccine targets. Several research-stage products have demonstrated positive results, and it says it is now working to advance selected targets into preclinical development, including its rabies vaccine.
Results with the rabies VLP vaccine demonstrated that two doses of one or four micrograms induced protective levels of neutralizing antibodies in a mouse model. Medicago says it expects to move ahead with GMP process development and a GLP toxicology study in 2012 and, following this, a Phase I clinical trial.
“The rabies virus is a significant problem, particularly in Asia, where current vaccines present challenges to access due to availability and cost, which we believe our VLP vaccine could address,” said Andrew Sheldon, the company’s president and CEO. “We see significant potential for our technologies in the development of VLP vaccines and biosimilars.”
Rabies is is responsible for approximately 55,000 deaths per year, primarily in Asia and Africa. While rabies vaccines produced in cell culture are currently available, there is limited access in many geographic areas and cost can be prohibitive. More than 15 million people are vaccinated annually following exposure to the rabies virus, many through a regimen requiring four to five intramuscular doses over three to four weeks. In addition, pre-exposure vaccination is recommended for high-risk groups such as veterinarians, animal handlers and certain laboratory workers.
Medicago says it is also working on the initiation of a US Phase IIa clinical trial for a trivalent seasonal vaccine with interim data expected in the third quarter of this year. A Phase I clinical trial for a one-dose H5N1 VLP vaccine with a new adjuvant is planned for the second quarter of 2012, in partnership with the Infectious Disease Research Institute (IDRI), with interim data expected in the second half of this year.