GOVX-B11 / GeoVax - LARVOL DELTA

GeoVax Reports 2020 Third Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is funding a clinical trial which includes our HIV preventive vaccine (GOVX-B11)...Through our mutual collaboration, American Gene Technologies International, Inc. (AGT) intends to conduct a Phase 1 human clinical trial with our combined technologies with the ultimate goal of developing a functional cure for HIV infection. We expect our vaccine to be added to an arm of the AGT trial in 2021. A consortium led by researchers at the University of California, San Francisco (UCSF) is using our vaccine as part of a combinational therapy intended to induce remission in HIV-positive individuals. This program entered clinical trials in August 2020."

New P1 trial • Trial status • Human Immunodeficiency Virus

GeoVax to Participate in World Vaccine Congress Session Addressing the Global Need for an HIV Vaccine (GlobeNewswire) - "GeoVax Labs, Inc....announced today that its Chief Scientific Officer Emeritus, Harriet L. Robinson, PhD, is an invited speaker at the 20th annual World Vaccine Congress, September 28th to October 1st....The title of her presentation is 'Non-Neutralizing Antibody and HIV Vaccines, Clinical and Preclinical Experience'. GeoVax’s preventive HIV vaccine candidate, GOVX-B11, is based on the use of DNA for priming and the company’s proprietary Modified Vaccinia Ankara virus (MVA) for boosting...Dr. Robinson will report studies in rhesus macaques addressing the addition of gp120 protein boosts to the MVA boost to enhance the induction of antibody-dependent cellular cytotoxicity (ADCC)."

Clinical • Preclinical • Human Immunodeficiency Virus

GeoVax Reports 2020 Second Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "GeoVax will provide its novel MVA-VLP-HIV vaccine (MVA62B) for evaluation in an arm of the clinical trial in combination with AGT103-T. AGT has stated its intention to begin recruiting patients for the Phase 1 study in 2020....Patient enrollment for the clinical trial is expected to commence in late 2020.; HIV Vaccines (Preventive)...The Company is now planning for a new Phase 1 human clinical trial (designated HVTN 132) to further assess the safety, tolerability, and immunogenicity (elicited antibody responses) of a prime-boost regimen of GOVX-B11 in combination with protein boost vaccines. Management has expected that HVTN 132 would commence patient enrollment in late 2020, but now anticipates the trial to start during the first half of 2021..."

Trial initiation date • Human Immunodeficiency Virus

GeoVax Reports 2020 First Quarter Financial Results and Provides Corporate Update (GlobeNewswire, GeoVax, Inc.) - "We are pleased with the progress of our three vaccine candidates for COVID-19. Safety, efficacy, and durability of protection (long-lasting) are the expected characteristics of our GV-MVA-VLP™ vaccine platform being used for constructing our vaccines....We will narrow to one vaccine candidate based on the safety, immunogenicity and protective efficacy....We plan to then proceed directly to manufacturing and initial human clinical testing for safety and immunogenicity....We expect BravoVax to provide testing and manufacturing support, as well as direct interactions with Chinese authorities, for a parallel regulatory pathway to what we will pursue in the United States. We have initiated discussions and submitted applications with U.S. funding agencies as well."

Clinical • Commercial • Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Evaluating the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); N=70 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal