GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human immunotherapies and vaccines against infectious diseases and cancer, announced today initiation of a Phase 1 clinical study of a combination therapy in HIV-positive patients utilizing GeoVax’s novel boost component MVA62B. The study is a collaboration of researchers led by Dr. Steven Deeks, Professor of Medicine in Residence at the University of California San Francisco (UCSF) and a faculty member in the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital. The study is designed to induce remission in HIV-positive individuals, also known as a “functional cure.” It is being funded by amfAR, The Foundation for AIDS Research.
The single-arm, open-label study will enroll 20 HIV-infected adults who are on stable and effective antiretroviral therapy (ART). The investigational regimen entails a combination of vaccinations (DNA priming and MVA boosting), administration of broadly neutralizing antibodies (bNAbs) and a Toll-like receptor 9 (TLR9) agonist. GeoVax is providing its novel boost component, MVA62B, for use in the studies. MVA62B is the boosting component for GeoVax’s preventive HIV vaccine, GOVX-B11, which has successfully completed a Phase 2a clinical trial.
“This Phase 1 trial will be the most comprehensive study to date to assess the efficacy of synergistic approaches to control HIV infection,” said Dr. Steven Deeks of UCSF. “The primary objectives are to assess the safety and tolerability of the combination therapy and to determine the viral load ’set-point’ during a treatment interruption. Secondary objectives include assessing immune responses and changes in viral reservoir status. We are pleased to partner in this study with GeoVax for its novel MBA62B boost component and look forward to working with the scientists at GeoVax to advance the trial.”
Harriet Robinson, Ph.D., CSO Emeritus of GeoVax, commented, “We have previously demonstrated that our HIV vaccine can stimulate production of both CD8+ and CD4+ T cells in HIV-positive individuals, which is the intended function of the MVA62B vaccine in the UCSF therapeutic study. Our vaccine also has a well-documented safety profile in more than 500 humans. We are hopeful that the combination of technologies in this study will yield a promising regimen to reduce the latent HIV reservoirs and thereby work towards a functional cure for HIV.”
“Advancement of this study into human clinical trials is an important step forward, and we anticipate starting enrollment of patients in the near term. Dr. Deeks and UCSF have identified infected individuals who are suited to this trial and are ready to move forward. The protocols, regulatory submissions and obtaining the products for this multi-product approach to HIV control have been in process for more than 2 years, and we are grateful to the members of the team who have worked diligently to reach this important inflection point. We are hopeful that this study will show both safety as well as improved drug-free control of viremia and reductions in viral reservoirs.”
David Dodd, GeoVax Chairman and CEO, concluded, “Initiation of the Phase 1 clinical trial represents the latest effort to find a functional cure for HIV/AIDS, and we are gratified to contribute to this important and ground-breaking research effort. While current antiretroviral therapy (ART) is effective at suppressing the viral load of HIV-infected individuals and preventing progression to AIDS, the long-term use of ART can lead to loss of drug effectiveness and severe side effects. We believe the approach we and UCSF are taking may result in an effective therapy that is safer than the current standard of care and will reduce the financial burden to the patient and to society, currently estimated at more than $350,000 over the course of a patient’s lifetime.”