Back in October 2014, Profectus BioSciences scored $9.5 million in Department of Defense funding to manufacture its trivalent vaccine to protect against Ebola and Marburg viruses. Now, the Baltimore-based biotech is taking its Ebola candidate to Phase I trials.
The VesiculoVax-vectored Ebola vaccine is a version of Profectus' vesicular stomatitis virus (VSV) vector that expresses the surface protein of the ebolavirus that caused the most recent outbreak. According to the company, humans have little preexisting immunity to such a vector. The vector can be modified to present surface proteins abundantly to induce the most effective antibody response.
Profectus' Phase I study will involve 39 volunteers, who will receive escalating doses of the Ebola vaccine that protected monkeys against lethal challenge in preclinical trials. Once safety and immunogenicity have been proven, the company's next step, anticipated for mid-2016, is to test its trivalent vaccine in clinical trials, said John Eldridge, Profectus chief scientific officer, in a statement. Following this, Profectus plans to test a freeze-dried formulation, which will be temperature-stable.
The company is also applying its VesiculoVax platform to vaccines for Lassa virus, encephalitic disease and arthralgic disease (Chikungunya). It is also working on therapeutic vaccines for HIV, HPV, hepatitis and herpes.
Profectus joins a crowded field of contenders vying to get an Ebola vaccine to market. Merck ($MRK) and NewLink Genetics' ($NLNK) candidate posted a 100% efficacy rate in a novel Phase III "ring" trial, GlaxoSmithKline ($GSK) reported Phase I results in November, and Johnson & Johnson ($JNJ) and Bavarian Nordic have their vaccines in Phase II trials as a prime-boost regimen. The waning of the most recent Ebola epidemic posed a hurdle for Ebola vaccine development, as there weren't enough people with exposure to Ebola on whom the companies could test their vaccines to see if they actually worked against Ebola infection.
- read the release (PDF)