NasVax (TASE: NSVX) announces that it has initiated recruitment and dosing in a Phase 2a clinical trial for oral anti-CD3 (aCD3) monoclonal antibody (MAb) immunotherapy. This study is being conducted at Hadassah Medical Center - Hebrew University in Jerusalem Israel in subjects with nonalcoholic steatohepatitis (NASH), a serious inflammatory disease of the liver, and including those with metabolic syndrome. This Phase 2a trial, which was recently approved by the Israel Ministry of Health, is designed to evaluate the safety and immune-modulatory effects of this immunotherapy. A published Phase 1 trial conducted at Hadassah Medical Center in 15 healthy volunteers who received aCD3 MAb showed that oral aCD3 immunotherapy is generally safe and induced immune-modulatory effects consistent with the induction of regulatory T cells and of anti-inflammatory immune responses. Such immune responses are associated with efficacy in animal models for inflammatory and autoimmune diseases, as published by the laboratory of Dr. Howard Weiner in Harvard Medical School and by others.
NasVax also announces that it has entered into an evaluation and option agreement with Centocor Ortho Biotech, in which Centocor will provide NasVax its aCD3 antibodies on beneficial commercial terms, to be used by NasVax for its clinical trials. In return, Centocor shall be given the exclusive option for several months after receiving the results of the clinical trial to conduct negotiations with NasVax towards a license and/or collaboration agreement relating to the aCD3 technology.
Dr. Rom Eliaz, new CEO of NasVax says: "We are excited to be embarking on our initial Phase 2a clinical trial with oral aCD3 immunotherapy for a medically and commercially significant indication. NASH affects a large number of subjects, including many with type-2 diabetes or who are overweight, and is in need of effective therapies."
NasVax develops improved vaccines and immunotherapeutic products. The company has four product development programs.
The aCD3 oral immunotherapy program employs a MAb for down-regulating pathogenic immune cells in inflammatory and autoimmune diseases. NASH represents the initial indication for a Phase 2a clinical trial with this approach.
VaxiSome(R) is an adjuvant / delivery system for enhancing the immunogenicity of vaccines and immunotherapeutics. VaxiSome-Influenza vaccine has been in a Phase 2 clinical trial that did not meet its primary immunological endpoint. The Company is working with Novartis under a Research and Option-for-License Agreement on applying VaxiSome to Novartis' influenza and one other vaccine target non-exclusively.
The group-common protein-based pneumococcal vaccine is a third-generation product in preclinical studies with potential improvements over current pneumococcal vaccines. A set of antigens in this project are the focus of a Research and Option-for-License Agreement with GlaxoSmithKline.
BBS1 is an immunotherapeutic MAb for Alzheimer's disease (AD) in preclinical studies. The BBS1 product 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.
Source: Nasvax Ltd