ANN ARBOR, Mich.—NanoBio Corp., a biopharmaceutical company developing and commercializing intranasal and intramuscular vaccines, announced that its intranasal nanoemulsion (NE) adjuvanted chlamydia vaccine has demonstrated efficacy in a traditional mouse challenge model. The study was conducted by leading chlamydia vaccine researchers at the Queensland University of Technology (QUT) in Brisbane, Australia, led by Dr. Kenneth Beagley, professor of immunology.
Chlamydia is one of the most commonly reported sexually transmitted diseases, both in the United States and globally. According to the U.S. Centers for Disease Control and Prevention, an estimated 2.86 million infections occur each year. Often referred to as a “silent” infection, estimates suggest 90 percent of women with chlamydia have no symptoms and therefore do not seek treatment. If untreated, a significant percentage of women develop pelvic inflammatory disease (PID) that can lead to lifelong complications including infertility, ectopic pregnancies and chronic pelvic pain. Untreated chlamydia also increases the likelihood of acquiring or transmitting HIV. Currently, there is no vaccine to prevent the spread of the disease.
In 2015, Selecta Biosciences Inc., a clinical-stage biotechnology company developing a novel class of targeted antigen-specific immune therapies using synthetic vaccine particles (SVP), announced a publication in Science describing the use of SVP to create a novel vaccine technology designed to target mucosal tissues. For many chronic and serious infectious diseases that thrive in mucosa, conventional vaccine approaches have not proven effective for reasons now elucidated in the publication. The new research, by Selecta founders Prof. Ulrich von Andrian and Prof. Omid Farokhzad at Harvard Medical School and Robert Langer at Massachusetts Institute of Technology, further demonstrates preclinical proof-of-concept for an SVP product to prevent Chlamydia trachomatis infections.
In the preclinical study, mice received three administrations of an intranasal NE vaccine and were then subsequently challenged intravaginally with chlamydia. The study’s principal endpoint measured oviduct pathology as an indicator of PID. The results showed that 100 percent of mice receiving no treatment developed oviduct pathology versus just 20 percent of mice receiving the NE vaccine (p<0.001). Animals that received the NE vaccine generated high levels of both serum and vaginal antibodies (IgG and IgA), strong IL-17 and interferon gamma responses and had faster clearing of the bacteria, as compared to the no-treatment control mice.
“Based on many years of research focused on chlamydia transmission and prevention, our findings indicate that the use of mucosal vaccination provides the best hope for the development of a vaccine to protect against chlamydia,” stated Dr. Kenneth Beagley, professor of immunology at QUT. “The initial study with NanoBio demonstrated exciting results from an intranasal NE vaccine incorporating a generic chlamydia protein. With these results in hand, we are now beginning to test additional chlamydia antigens combined with the intranasal NE adjuvant in mice and larger animal models.”
David Peralta, CEO of NanoBio, added, “The results of the chlamydia study further validate the opportunity for intranasal NE vaccines to play a key role in the prevention of sexually transmitted diseases. We have now observed positive results in animal studies for three STDs: genital herpes, HIV and chlamydia. Our research has demonstrated the critical importance of eliciting both mucosal and systemic immunity to protect against some of the most concerning pathogens that enter the body across mucosal surfaces.”
Headquartered in Ann Arbor, Mich., NanoBio is a privately held biopharmaceutical company focused on developing and commercializing vaccines and anti-infective treatments derived from its patented NanoStat technology platform. The company’s NanoStat vaccine technology employs a novel oil-in-water NE that can incorporate, deliver and adjuvant multiple antigen types. The NE adjuvant is effective when administered via intranasal or intramuscular vaccination, and when applied intranasally, these vaccines trigger mucosal and systemic immunity.
NanoBio is currently developing intranasal NE vaccines for several respiratory and sexually transmitted diseases, including pertussis, pandemic influenza, anthrax, prophylactic and therapeutic HSV2, chlamydia and HIV. In addition, the company has licensed its NE adjuvant to Merck for use in respiratory syncytial virus and seasonal influenza vaccines.