GeoVax is a clinical-stage

biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...

company which develops vaccines. GeoVax's development platform uses

Modified Vaccinia Ankara Modified vaccinia Ankara (MVA) is an attenuated (weakened) strain of the vaccinia virus. It is being used as a vaccine (called MVA-BN, brand names: Imvanex in the EU, Imvamune in Canada, and Jynneos in the US) against smallpox and mpox, having ...

(MVA) vector technology, with improvements to antigen design and manufacturing capabilities. GeoVax uses recombinant DNA or recombinant viruses to produce

virus-like particle Virus-like particles (VLPs) are molecules that closely resemble viruses, but are non-infectious because they contain no viral genetic material. They can be naturally occurring or synthesized through the individual expression of viral structural pro ...

s (VLPs) in the person being vaccinated.

History

Formed in 2001 in

Atlanta, Georgia Atlanta ( ) is the List of capitals in the United States, capital and List of municipalities in Georgia (U.S. state), most populous city in the U.S. state of Georgia (U.S. state), Georgia. It is the county seat, seat of Fulton County, Georg ...

, the approach was originally based on

preclinical In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and dr ...

work done by Harriet Robinson from 1992 to 2002. In 2002, laboratory space, equipment and personnel were acquired and work on an

HIV-1 The subtypes of HIV include two main subtypes, known as HIV type 1 (HIV-1) and HIV type 2 (HIV-2). These subtypes have distinct genetic differences and are associated with different epidemiological patterns and clinical characteristics. HIV-1 e ...

vaccine development plan began. In May 2006, human

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

s of the drug began. The company is now working on

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...

s for

Marburg Marburg (; ) is a college town, university town in the States of Germany, German federal state () of Hesse, capital of the Marburg-Biedenkopf Districts of Germany, district (). The town area spreads along the valley of the river Lahn and has ...

Lassa Fever Lassa fever, also known as Lassa hemorrhagic fever, is a type of viral hemorrhagic fever caused by the Lassa virus. Many of those infected by the virus asymptomatic, do not develop symptoms. When symptoms occur they typically include fever, wea ...

Ebola Ebola, also known as Ebola virus disease (EVD) and Ebola hemorrhagic fever (EHF), is a viral hemorrhagic fever in humans and other primates, caused by ebolaviruses. Symptoms typically start anywhere between two days and three weeks after in ...

Zika Zika fever, also known as Zika virus disease or simply Zika, is an infectious disease caused by the Zika virus. Most cases have no symptoms, but when present they are usually mild and can resemble dengue fever. Symptoms may include fever, conju ...

and

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by the coronavirus SARS-CoV-2. In January 2020, the disease spread worldwide, resulting in the COVID-19 pandemic. The symptoms of COVID‑19 can vary but often include fever ...

. In January 2020, the company announced initiation of efforts to develop a vaccine against novel coronavirus disease (COVID-19) caused by the SARS-CoV-2 coronavirus. The GeoVax program has been added to the "Draft Landscape of COVID-19 Candidate Vaccines" by the World Health Organization. On September 25, 2020, GeoVax closed an underwritten public offering, raising gross proceeds of $12.8 million. Concurrent with the offering, GeoVax common stock began trading on The

Nasdaq Capital Market The Nasdaq Stock Market (; National Association of Securities Dealers Automated Quotations) is an American stock exchange based in New York City. It is the most active stock trading venue in the U.S. by volume, and ranked second on the list ...

under the symbol "GOVX". Recently, the company began collaborating with

Emory University Emory University is a private university, private research university in Atlanta, Georgia, United States. It was founded in 1836 as Emory College by the Methodist Episcopal Church and named in honor of Methodist bishop John Emory. Its main campu ...

on the development of a therapeutic vaccine for human papillomavirus (HPV) infection, with a specific focus on head and neck cancer (HNC).

Non-Covid Pipeline: Disease Definitions and Stats

HIV/AIDS

In human clinical trials of the company's HIV vaccines, GeoVax demonstrated that VLPs are safe and eliciting both strong and durable humoral and cellular immune response.

Pre-Clinical and Clinical History

From

results (using SHIV) 96% of primates (22/23) were protected from the virus over a three-and-a-half-year period when

vaccinated A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...

, while by contrast five out of six primates died within eight months after being infected when left untreated. The

works with a combined

DNA Deoxyribonucleic acid (; DNA) is a polymer composed of two polynucleotide chains that coil around each other to form a double helix. The polymer carries genetic instructions for the development, functioning, growth and reproduction of al ...

vaccine and MVA (

modified vaccinia Ankara Modified vaccinia Ankara (MVA) is an attenuated (weakened) strain of the vaccinia virus. It is being used as a vaccine (called MVA-BN, brand names: Imvanex in the EU, Imvamune in Canada, and Jynneos in the US) against smallpox and mpox, having ...

)

both of which lead to the insertion of

genes In biology, the word gene has two meanings. The Mendelian gene is a basic unit of heredity. The molecular gene is a sequence of nucleotides in DNA that is transcribed to produce a functional RNA. There are two types of molecular genes: protei ...

into primate

which leads to foreign protein expression. With the GeoVax vaccine a variety of

HIV The human immunodeficiency viruses (HIV) are two species of '' Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the im ...

proteins (both surface and internal) are expressed from

which include the Env, Pol and Gag genes. GeoVax is currently conducting multiple site Phase 2 Human

s for HIV/AIDS preventive

products following successful completion of multiple Phase 1 human

s. In 2010 GeoVax began enrolling patients in a Phase 1 therapeutic

for individuals already infected with

. The long-term

therapeutic A therapy or medical treatment is the attempted remediation of a health problem, usually following a medical diagnosis. Both words, ''treatment'' and ''therapy'', are often abbreviated tx, Tx, or Tx. As a rule, each therapy has indications an ...

goal is to develop a vaccine-based mechanism to treat infected individuals that either prevents or significantly slows progression to symptomatic

, including

AIDS The HIV, human immunodeficiency virus (HIV) is a retrovirus that attacks the immune system. Without treatment, it can lead to a spectrum of conditions including acquired immunodeficiency syndrome (AIDS). It is a Preventive healthcare, pr ...

, by stimulating an infected individual's immune system to resist the progression of infection. The study is being completed at the AIDS Research Consortium of Atlanta.

Past trials

Therapeutic Vaccine Clinical Trials

During 2010, the AIDS Research Consortium of Atlanta (ARCA) began patient recruitment for a Phase 1

sponsored by GeoVax Labs, Inc., investigating GeoVax's DNA/MVA vaccine as a treatment for individuals already infected with

. The trial is primarily designed as a safety study, but will also collect and report data on the vaccine's ability to elicit protective immune responses and control re-emergent virus during a pause in drug treatment. As part of the trial protocol, a volunteer must have begun drug treatment in the first year of infection and have achieved 6 months of stable viral control on drug treatment before entry into the trial and receipt of the first vaccination.

Preventive Vaccine Clinical Trials

GeoVax published results of Phase 1 safety and immunogenicity testing for its preventive vaccine trial on March 1, 2011. Based on published results, GeoVax will be advancing two regimens forward into the Phase 2a HVTN 205 trial. Regimens selected for advancement are the DDMM combination, which produced the highest

T cell T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...

response rates, and the MMM combination. The MMM regimen produced the highest

antibody An antibody (Ab) or immunoglobulin (Ig) is a large, Y-shaped protein belonging to the immunoglobulin superfamily which is used by the immune system to identify and neutralize antigens such as pathogenic bacteria, bacteria and viruses, includin ...

-induced

immune In biology, immunity is the state of being insusceptible or resistant to a noxious agent or process, especially a pathogen or infectious disease. Immunity may occur naturally or be produced by prior exposure or immunization. Innate and adaptive ...

response. The DDMM regimen consists of priming with two doses of the pGA2/JS7 recombinant DNA vaccine and boosting with two doses of VA/HIV62B recombinant MVA vaccine. The MMM regimen consists of priming and boosting with a total of three doses of the recombinant MVA vaccine. HVTN 205 Study—In early 2009, the HVTN began enrolling patients in a preventive Phase 2

sponsored by GeoVax Labs, Inc. This study is investigating a prime-boost approach using GeoVax's combination DNA/MVA vaccine. During 2010, the study was expanded from 225 to 300 participants to include an arm gathering additional data on three MVA injections, without the use of the DNA component, which is an addition to the original arm testing two DNA priming and two MVA boosting injections. Preliminary results were announced by the company on December 9, 2010. Preliminary results indicate an excellent safety profile and highly reproducible immunogenicity subsequently confirmed by the official publication above in ''The Journal of Infectious Diseases''.

Phase 2a Clinical Trial Expansion

In April 2011, GeoVax Labs, Inc. in collaboration with the

National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID, ) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. NIAID's mis ...

(NIAID), part of the U.S.

National Institutes of Health The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. It was founded in 1887 and is part of the United States Department of Health and Human Service ...

(NIH) and the

HIV Vaccine Trials Network The HIV Vaccine Trials Network (HVTN) is a non-profit organization which connects physicians and scientists with activists and community educators for the purpose of conducting clinical trials seeking a safe and effective HIV vaccine. Collaborati ...

(HVTN) announced an expansion of the current Phase 2a clinical trial to include a new component. The new trial is HVTN 094 and will be conducted by the

. "Specifically, the HVTN plans to clinically test a novel vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with inactivated HIV proteins. The novel vaccine consists of a recombinant DNA vaccine co-expressing human GM-CSF and non-infectious HIV virus-likeparticles. The DNA vaccine is used to prime immune responses that are subsequently boosted by vaccination with a recombinant modified vaccinia Ankara (MVA) vectored vaccine. The MVA expresses the HIV virus-like-particles, but does not express GM-CSF. The regimen builds on the GeoVax DNA/MVA vaccine that is currently in Phase 2a clinical testing through the HVTN.""Encouraged By Early Clinical Studies, A Biotech Company Expands Its HIV/AIDS Vaccine Program."
''Medical News Today.'' April 12, 2011.

References

;Notes

External links

GeoVax

GeoVax News Links

GeoVax Video Links

Relevant Published Research
{{DEFAULTSORT:Geovax Biotechnology companies of the United States Companies based in Atlanta HIV vaccine research Biotechnology companies established in 2001 2001 establishments in Georgia (U.S. state)