NasVax develops improved vaccines and immunotherapeutics.
Anti-CD3 oral immunotherapy: Oral anti-CD3 monoclonal antibody (aCD3 MAb) immunotherapy is directed toward the treatment of inflammatory and autoimmune diseases. Intravenous aCD3 MAb immunotherapy has been approved for >20 years for the treatment of graft rejection after transplantation; however, its use for chronic inflammatory and autoimmune disease indications has been hampered due to its profile of significant AEs following injection. Preclinical studies have shown that oral aCD3 MAb does not induce side effects and confers efficacy in preventing induction or progression of disease in a range of animal models of inflammatory and autoimmune diseases. These studies also showed that oral aCD3 MAb induces regulatory T cells (Treg) and anti-inflammatory immune responses that convey efficacy. In a Phase 1 clinical study in healthy subjects, oral aCD3 MAb was found to be generally safe and was not found to enter the bloodstream, and thus is expected to not pose the safety concerns associated with injected aCD3 MAb. In this Phase 1 study, oral aCD3 MAb induced immunological markers consistent with the induction of Treg and of anti-inflammatory immune responses. The oral application for aCD3 MAb immunotherapy was discovered by Dr. Howard Weiner of Brigham & Women’s Hospital, Harvard Medical School in Boston, USA.
A Phase 2a clinical trial is approved to begin at Hadassah Hospital in Jerusalem to study the safety and immune-modulatory effects of oral aCD3 immunotherapy in subjects with NASH (Nonalcoholic steatohepatitis) or “fatty liver”. We are collaborating with Centocor Ortho Biotech under a Material Transfer, Evaluation and Option Agreement.
Adjuvant-Delivery platform: The VaxiSome® technology platform serves both as a potent adjuvant for stimulating enhanced immune responses via the Th1 and Th2 pathways as well as an efficient delivery system. This liposomal adjuvant – delivery system also may be applied to augment the bioactivity of other established adjuvants and cytokines. Preclinical studies have shown that VaxiSome-Influenza vaccine is significantly more protective than conventional commercial influenza vaccine and significantly more immunogenic than two commercial adjuvanted influenza vaccines. Studies with adjuvanted hepatitis B, anthrax as well as both swine and avian flu vaccine antigens have demonstrated increased potency. The adjuvant effect of VaxiSome was apparent in Phase 1/2a clinical trials of intramuscular commercial influenza vaccine (VaxiSome-Influenza). Given that immunotherapeutic vaccines generally use adjuvants to amplify immune modulation and since dual Th1/Th2 activities are useful for augmenting both antibody and cell-mediated responses, VaxiSome may be a useful adjunct to immunotherapeutic applications such as cancer and Alzheimer’s disease.
The novel family of lipids in VaxiSome® was co-developed at the Hebrew University in Jerusalem by Professors Eli Kedar and Yechezkel Barenholz, who is a co-inventor of the anticancer drug that is marketed in the USA by Johnson & Johnson (as DoxilTM) and in Europe by Merck (as Caelyx).
We are working with Novartis on applying VaxiSome® non-exclusively to Novartis’ influenza and one other vaccine target under a Research and Option-for-License Agreement.
Group-common Pneumococcal Vaccine: Current pneumococcal vaccines are specific to certain serotypes of Streptococcus pneumoniae, and as a result do not protect against pneumococcal disease-causing strains in general. The group-common pneumococcal vaccine is based on surface proteins that are highly conserved among pneumococcal strains, hence able to stimulate protective immune responses against pneumococcal strains in general. As a result, such a vaccine may be more broadly protective than available vaccines, and thus is a very promising next-generation vaccine. A range of proteins has been discovered and are being developed as a candidate vaccine.
The vaccine antigens are protected by registered patent applications, having been discovered by Professors Yaffa Mizrachi-Nebenzahl and Ron Dagan of Ben-Gurion University in Israel, recognized international experts in the field of pneumococcal vaccines.
A set of these proteins form the basis of the joint Research and Option-for-License Agreement with GSK.
Alzheimer’s Disease Immunotherapy: BBS1 technology is focused on developing immunotherapeutic products for Alzheimer’s disease (AD). It has been shown by several groups that antibodies, either administered by injection or elicited by a vaccine, have immunotherapeutic activity in preventing disease progression in animal models of AD. Clinical studies with both approaches also have shown some promising results. The BBS1 approach has a novel mechanism of action that makes it distinctive and that could offer certain safety and efficacy advantages over other immunotherapeutic approaches for AD. The two product applications are a monoclonal antibody (MAb) and an active vaccine that would elicit antibodies of similar specificity as the MAb. The MAb has shown initial efficacy and an improved safety profile in animal models of AD. The BBS1 technology, encompassing both MAb and vaccine immunotherapeutics, is protected by a family of several registered patents and patent applications. The technology was developed by Professor Beka Solomon of Tel-Aviv University in Israel, a recognized international expert in the field of AD research and immunotherapeutics.