Candidate contains DNA coding for Aβ42 and is expected to be better than a peptide vaccine.
Nuron Biotech has licensed from Vitruvian BioMedical a gene-based amyloid beta 42 (Aβ42) vaccine that is in preclinical development for Alzheimer disease (AD). Nuron obtained an exclusive, worldwide license for the vaccine and is responsible for development and commercialization.
The DNA vaccine candidate was created at the University of Texas Southwestern Medical Center. The vaccine does not contain amyloid beta itself but instead contains a piece of the gene coding for the amyloid beta protein. Once in the body, the vaccine stimulates an immune response in which antibodies that bind to and significantly reduce amyloid beta are produced.
“Research has shown that this adjuvant-free DNA vaccine is far superior to a peptide-based vaccine as it significantly reduces the levels of Aβ42 by about 50 percent in preclinical models, and importantly, it does not generate an inflammatory immune response in the brain,” notes Arthur Bollon, Ph.D., CEO and founder of Vitruvian.
Shankar Musunuri, Ph.D., CEO and founder of Nuron Biotech, adds, “This unique, promising vaccine candidate brings more opportunity to our pipeline and is one of the most promising new advances to improve the lives of Alzheimer’s patients worldwide.”
Nuron’s lead candidate is an interferon beta product for multiple sclerosis (MS). The company does have one vaccine in its portfolio; it acquired HibTiter® from Wyeth, a wholly owned subsidiary of Pfizer, for the U.S. and many other markets including Japan and Korea. It subsequently gave Mitsubishi Tanabe Pharma Japanese rights. HibTiter is a glycoconjugate technology vaccine on the market for reducing the incidence of Hib disease in children. The company says that it is in discussions with other companies to expand its portfolio in the areas of preventive and therapeutic vaccines.
Its MS candidate, NU100, is a recombinant human interferon beta-1b produced utilizing PreEMT™ technology. It is being developed as a standalone molecule for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) in Phase III trials. NU100 is a liquid product with an autoinjector and essentially aggregate free compared to other marketed interferon beta products. This is expected to result in lower immune responses in patients compared to other marketed products. By reducing or eliminating immune responses to interferon beta, NU100 should prevent the reduction in clinical efficacy and improve the tolerability and safety for RRMS patients who presently require therapy with interferon beta-1b.
Nuron also has a long-acting interferon beta-1b candidate, NU400, which is expected to enter the clinic early this year. It is produced using a combination of NU100 and TheraPEG™ technology. PEGylating NU100 can increase NU100′s circulating half-life and potentially improve other pharmaceutical properties including its solubility, stability, and safety profile. NU400 should carry the benefit of NU100 with reduced injection frequency, potentially semi-monthly or monthly injection for better patient compliance.