UBI has two HIV vaccines in development.
Our first product, UBI HIV-RC vaccine, is an investigational UBITh peptide-based immunotherapeutic vaccine for HIV-infected patients, targeting the recognition site for mAb DB4C7 on the CD4 molecule of human T lymphocytes. The UBI HIV-RC vaccine is being manufactured for efficacy, safety and toxicology studies in non-human primates, and in preparation for IND submission. The pre-clinical development studies and the production of clinical grade HIV-RC vaccine for the trials are being funded by a five-year contract award from the NIH in the amount of US$17 million.
Our second product, UBI HIV gp120, is an immunotherapy of HIV intended as a preventative vaccine for uninfected people and as an immunotherapeutic vaccine for infected people. Its primary active ingredient is an investigational UBITh® peptide modeled and developed to generate an antibody response against a crucial site on the major component of the HIV surface, envelop glycoprotein 120 (gp120). HIV gp120 has remarkable diversity, it is largely concealed from the immune system by sugars, and it has remarkable conformational flexibility. The glycoprotein displays substantial conformational rearrangement upon binding the CD4 receptor. All of this has allowed it to evade antibody-mediated neutralization. This complex nature of gp120 has stymied the research community from producing effective gp120 immunogens capable of mediating HIV entry inhibition. Hence, the development of a protective HIV vaccine has been delayed since the initial characterization of the HIV sequence and structure over twenty-three years ago. Despite this complexity, the HIV gp120 must retain conserved determinants that mediate CD4 binding. The company has developed a high precision UBITh® HIV gp120 peptide immunogen that mimics a dynamic conformational model of the site on gp120 that is formed as the virus glycoprotein attaches to the CD4 host cell receptor. Consequently, this UBITh® immunogen induces an anti-HIV antibody response that blocks HIV from binding to the CD4 cell surface receptor, thereby inhibiting the initial step that leads to HIV infection.