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GOVX: Continues to move forward with its Multiple Vaccine Programs

By Grant Zeng, CFA


Update on Third Quarter Financials 

GeoVax (OTC:GOVX) recently reported its financial results for the fiscal third quarter ended September 30,2017. Following are summaries for the major financials. 

Total revenue, which included grant and collaboration revenue, was $247,997 for the three-month period of 2017, respectively. This compared to $440,106 for the comparable period of 2016. 

The company also reported $744,769 in approved grant funds remaining and available for use as of September 30, 2017. 

R&D expenses for the third quarter of 2017 were $498,200, as compared to $683,939 for the comparable period of 2016. R&D expenses included direct costs funded by NIH grants, as well as other vaccine manufacturing and testing costs. 

G&A expenses were $340,143 for the three-month period of 2017, as compared to $220,707 for the comparable period of 2016.

Net loss was $588,787 ($0.01 per share) for the three months ended September 30, 2017, compared to $464,200 ($0.01 per share) for the same period in 2016. 

Cash balance was $343,826 as of September 30, 2017, as compared to $454,030 at December 31, 2016. 

Update on the HIV Preventive Vaccine Program

The company’s most advanced program is a preventive vaccine (GOVX-B11) for the Clade B subtype of HIV, the most common form of HIV in developed countries. 

In Jan 2017, GeoVax initiated the Phase I clinical trial (HVTN 114) of GOVX-B11. The Phase I trial is being conducted by the HIV Vaccine Trials Network (HVTN) and is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The trial will enroll up to 30 individuals who participated in the HVTN 205 Phase IIa trial of the GOVX-B11 vaccine (concluded in 2012) and will evaluate the durability of immune responses elicited by GOVX-B11 and the effects of late boosts (additional vaccinations) on the antibody responses elicited by the GOVX-B11. These “late boosts” consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX® B/E, supplied by Global Solutions for Infectious Diseases (GSID), is the same protein used to boost immune responses in the partially protective RV144 trial in Thailand, and is being used here to assess the effect of late boosts of GOVX-B11 while newer proteins are cGMP manufactured and safety tested for use with GOVX-B11 in future clinical trials. Eligible participants in HVTN 114 will receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX® B/E, or (c) AIDSVAX® B/E alone.

GOVX-B11 is a DNA/MVA vaccine that expresses non-infectious virus-like particles (VLPs). Clinical trials for GOVX-B11 have been conducted by the NIH-supported HIV Vaccine Trials Network (HVTN) with funding from the National Institute of Allergy and Infectious Disease (NIAID). The HVTN has tested various doses and combinations of the DNA and MVA vaccines in 500 humans with very encouraging results. 

The next planned clinical trial of GOVX-B11 will be an additional Phase I trial, evaluating the safety and immunogenicity of a prime-boost regimen of GOVX-B11 with and without two additional protein boosts. This trial will be conducted by HVTN with funding from NIAID. GeoVax anticipates a start date in mid-2018. Both this trial and HVTN 114 will contribute data critical in determining the regimen to be used in a future Phase IIb efficacy trial. 

The company also continued preclinical work funded by grants from NIAID for its vaccine for the clade C HIV subtype prevalent in Africa. In October 2017, the Company reported the elicitation of a key precursor for broadly neutralizing antibody for the HIV CD4 binding site, a significant advance in HIV vaccine development. 

Update on the Zika Virus Program

The company has a research collaboration with the Centers for Disease Control and Prevention (CDC) for development of preventive vaccine against Zika virus (ZIKV).  

GeoVax’s vaccine GEO-ZM02 is based on the non-structural-1 (NS1) protein of ZIKV, which is not involved in ADE. Moreover, the NS1 protein is abundantly secreted into the blood of ZIKV infected individuals and plays a critical role in flavivirus acquisition by mosquitoes by overcoming the immune barrier of the mosquito midgut. Therefore, GEO-ZM02 should not only safely protect populations against ZIKV infections but could also block further transmission of ZIKV from humans to its mosquito vector.

In June 2017, GeoVax presented animal data of the Zika vaccine at the American Society for Microbiology (ASM) Microbe conference in New Orleans. 

In the study, outbred immunocompetent mice were exposed to a lethal challenge dose of ZIKV delivered directly into the brain. A single dose of GeoVax’s NS1 vaccine candidate GEO-ZM02 protected 100% of vaccinated mice. In contrast, 80-90% of sham-immunized control mice died within 7-10 days.

This is the first report of a Zika vaccine based on the ZIKV NS1 protein, which demonstrated a single-dose protection against ZIKV using an immunocompetent lethal mouse challenge model.

GEO-ZM02 has the potential to be a single-dose vaccine, which is practical to combat epidemics in resource strained countries, Furthermore, the vaccine does not bear the risk of enhancing other flavivirus infections, such as Dengue virus, in vaccinated subjects. This phenomenon, called Antibody Dependent Enhancement (ADE), is a safety concern for other Zika vaccines under development, all of which utilize the structural Envelope (E) protein of ZIKV in their vaccine constructs. 

Zika virus disease is a rapidly spreading, emerging infectious disease transmitted by mosquitoes. The rapid spread of ZIKV, its association with abnormal fetal brain development, and lack of a preventive vaccine constitute a global health emergency. As of May 9, 2017, there have been 1,845 and 3,795 cases of pregnant women with evidence of ZIKV infection in the US and US territories, respectively. Seventy-two infants were born in the US alone with ZIKV related birth defects. Protection against mosquito bites and vector control remain the key preventive measures currently available to fight ZIKV infections. ZIKV belongs to the flaviviridae family which also include, dengue, West Nile and yellow fever viruses. 

Also in June, the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), awarded GeoVax a Small Business Innovative Research (SBIR) grant of $600,000 to support advanced preclinical testing, including non-human primates studies, for its Zika vaccine development program in preparation for a Phase I human clinical study.

The Hemorrhagic Fever Viruses Program

GeoVax is developing a tetravalent vaccine designed to protect against all major hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) endemic in African countries. Each vaccine virus can also be developed as a monovalent vaccine. 

The company has proven 100% protection in rodent and non-human primate challenge studies for Ebola vaccine (GEO-EM01), and has demonstrated VLP production for each of the vaccines. The tetravalent vaccine currently is being tested in a rodent challenge study before progressing to non-human primates.

In July 2017, GeoVax reported very promising animal data for a vaccine candidate for protection against Lassa hemorrhagic fever virus (LASV). Efficacy testing in a murine challenge model (using a chimeric LASV reassortant) showed a single dose of GEO-LM01, provided 100% protection to mice infected with a lethal dose of the challenge virus. The study was conducted, and successfully repeated, at the Institute of Human Virology at the University of Maryland School of Medicine. In October, at the International Society for Vaccines, at the Institute Pasteur in Paris, France, GeoVax presented updates on efficacy data of its single dose vaccine for Lassa fever virus.

GeoVax recently expanded its LASV vaccine development efforts through a collaboration with The Scripps Research Institute.

In addition to developing the four individual hemorrhagic fever vaccines (EBOV, LASV, SUDV, MARV), the Company's goal is to combine the vaccines into a single tetravalent vaccine to provide broad protection for individuals at-risk for these viruses.


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