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Saturday, October 1, 2022

Geovax Labs Inc (NASDAQ: GOVX) Volatile Biotech Developing Vaccines for Monkeypox, Covid-19, Ebola, Malaria and Zika

Geovax Labs Inc (NASDAQ: GOVX) is a highly volatile stock that spent most of its history on the OTC where we reported on it many times and has recently graduated to the NASDAQ. Since drifting under $1 in May the stock spiked to $3, drifted back under $1 in July and then ran over $4. Currently GOVX is making another strong move over $1 running to $1.80 on Friday. Since landing on the NASDAQ GOVX has continued to improve its financial position and is currently well funded with $30 million in the treasury. The Company is developing vaccines for the Monkeypox, has a Covid-19 booster candidate, and is working on vaccines for the Ebola, Malaria and Zika viruses. GOVX is also at work on two cancer therapies. On Monday GOVX CEO, David Dodd held a conference presenting a company overview at the H.C. Wainwright 24th Annual Global Investment Conference.  

Over the past 6 months GeoVax strengthened its organizational and operational resources in several areas to support its advancement through clinical development and regulatory registration.  The Company’s corporate priorities continue to be the clinical programs for SARS-CoV-2 and Gedeptin as well GOVX is focused on expanding its clinical sites for these trials and accelerating patient enrollment. Recently the Company engaged Allucent (formerly known as CATO SMS) to manage the ongoing Phase 1/2 trial of Gedeptin® therapy in patients with recurrent head and neck squamous cell carcinoma. The Company further engaged Allucent to manage the two ongoing Phase 2 clinical trials of GEO-CM04S1, against SARS-CoV-2. Currently, evaluation is underway related to GEO-CM04S1 and the prevention of Monkeypox. It is anticipated that the results will demonstrate successful protection, validating that GEO-CM04S1 is protective against both COVID-19 and Monkeypox.  GeoVax also anticipates validating its hemorrhagic fever virus vaccines as protective against Monkeypox, potentially providing unique vaccines preventing both hemorrhagic fever virus and Monkeypox virus in a single vaccine. 

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Geovax Labs Inc (NASDAQ: GOVX) is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer using novel proprietary platforms. GeoVax’s product pipeline includes two ongoing Phase 2 clinical trials of GEO-CM04S1 for COVID-19 as a universal booster vaccine to mRNA vaccines authorized by the U.S. Food and Drug Administration (FDA) and as a primary vaccine for use in immunocompromised patients. In addition to GEO-CM04S1 for COVID-19, GeoVax is developing GEO-CM02 as a pan-coronavirus vaccine. The Company is also conducting a Phase 1/2 clinical trial of Gedeptin®for treatment of head and neck cancer. Gedeptin®has been granted orphan drug status by the FDA. Additional research and development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and malaria, as well as immunotherapies for multiple solid tumors. The Company’s portfolio of wholly owned, co-owned, and in-licensed intellectual property stands at over 70 granted or pending patent applications spread over 20 patent families. 

COVID-19 VACCINE DEVELOPMENTS & PROGRESS 

Phase 2 Trials – GEO-CM04S1 – GEO-CM04S1 is being studied in a Phase 2 clinical trial (NCT04977024) as a primary vaccine for immunocompromised cancer patients who have difficulty producing antibodies and largely depend on T cells to protect against the virus responsible for COVID-19. In this study, CM04S1 is being directly evaluated in comparison to the Pfizer/BioNTech mRNA authorized vaccine. 

GEO-CM04S1 is also being evaluated in a Phase 2 vaccine booster trial format (NCT04639466), which is aimed at evaluating how GEO-CM04S1 may boost pre-existing vaccine immunity to spike while also inducing a strong immune response to nucleocapsid. GEO-CM04S1 is unique to other COVID-19 vaccines in that it targets both the spike and nucleocapsid proteins. In contrast, the current U.S. Food and Drug Administration-approved COVID-19 vaccines only target the spike protein. During the second quarter of 2022, the Investigational New Drug (IND) applications for each of these clinical trials were successfully transferred from City of Hope to GeoVax, and GeoVax is now focused on accelerating patient enrollment for the studies. 

In March 2022, data from a Phase 1 study of GEO-CM04S1 (formerly known as COH04S1) were published in the peer-reviewed journal, The Lancet Microbe.  The publication, accessible here, reports data showing that GEO-CM04S1 produced robust neutralizing antibodies and T cells against SARS-CoV-2 with no significant side effects. These data confirm the powerful dual action of the GeoVax vaccine, an important feature given the multiple mutations in spike, leading to variants of concern and inconsistent protection from existing FDA-approved vaccines. Should a new mutation arise in the spike antigen that interferes with antibody recognition, a person vaccinated with our vaccine may still have substantial T cell immunity against both the nucleocapsid and spike antigens. 

More recently, in July, additional analyses of data from the Phase 1 study of GEO-CM04S1 published in the peer-reviewed journal, iScience (accessible here) show that GEO-CM04S1 demonstrated potent and equivalent T-cell cross-reactivity against Delta and Omicron variants. These findings suggest that T-cell immunity stimulated by GEO-CM04S1 may constitute a critical second line of defense to provide long-term protection against SARS-CoV-2 variants. 

Pan-Coronavirus Vaccine (GEO-CM02) – In addition to the clinical programs for GEO-CM04S1 for COVID-19, GeoVax continued to assess GEO-CM02 as a potential single-dose universal coronavirus vaccine during the first quarter. This program was supported by a Small Business Innovation Research (SBIR) grant from the NIH during 2021. In small animal studies, the Company measured functional immune responses after a single dose that mediated protection from infection and pathogenesis, including protection against the more virulent Beta variant. 

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GOVX

IMMUNO-ONCOLOGY DEVELOPMENTS & PROGRESS 

Phase 1/2 Trial – Gedeptin® – A Phase 1/2 trial (NCT03754933) evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC) that have tumor(s) accessible for injection and no curable treatment options, is ongoing at Stanford University in collaboration with Emory University. The trial design involves repeat administration using Gedeptin, followed by systemic fludarabine, to gain additional information prior to expansion towards a larger patient trial. The initial stage of the study is being funded by the FDA under its Orphan Products Clinical Trials Grants Program. The FDA has also granted GedeptinOrphan Drug Status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities. This trial is currently being expanded to a multi-site trial with a focus on accelerated patient enrollment. 

MVA-VLP-MUC1 for Solid Tumor Cancers – In March, GeoVax announced that the U.S. Patent and Trademark Office issued Patent No. 11278607, pursuant to the Company’s patent application No. 16/068,527 titled, “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.”  The claims granted by the patent generally cover GeoVax’s vector platform for expressing tumor associated antigens in virus-like particles (VLPs) from a Modified Vaccinia Ankara (MVA) viral vector and encompass GeoVax’s Mucin 1 (MUC1) tumor-associated antigen immunotherapy candidate. The Company uses its GV-MVA-VLPTM vaccine platform to express abnormal, aberrantly glycosylated forms of the cell surface-associated MUC1 protein that is associated with a wide range of cancers, including breast, colon, ovarian, prostate, pancreatic, and lung. 

GeoVax recently began an animal study with Dr. Pinku Mukherjee at the University of North Carolina at Charlotte to define the optimal course and schedule of vaccination to define a protocol that can be evaluated in a Phase 1 clinical trial for the Company’s MVA-VLP-MUC1 immunotherapy candidate. 

HEMORRHAGIC FEVER VIRUS VACCINES DEVELOPMENT & PROGRESS 

In July, GeoVax announced the publication of a peer-reviewed animal efficacy study of its modified vaccine Ankara (MVA) vectored vaccine against Sudan ebolavirus (SUDV) in Nature Partner Journals (NPJ) Vaccines. GeoVax’s vaccine, MVA-VLP-SUDV, combines the advantages of the immunogenicity of a live attenuated vaccine vector with the authentic conformation of VLPs. The vaccine expresses minimal components to generate self-assembling VLPs in the vaccinee: the envelope glycoprotein GP and the matrix protein VP40. Guinea pigs vaccinated with one dose of MVA-VLP-SUDV generated SUDV-specific binding and neutralizing antibody responses as well as Fc-mediated protective effects. These responses were boosted by a second vaccine dose. All vaccinated animals which received either one or two vaccine doses were protected from death and disease symptoms following challenge with a lethal dose of SUDV. These data demonstrate single dose protection and potency of the MVA-VLP platform for use in emergency situations to contain outbreaks.  The next stage of testing involving nonhuman primates is nearing completion. 

MODIFIED VACCINIA ANKARA (MVA) & MONKEYPOX 

The vaccine used and stockpiled for immunization against Monkeypox is MVA, which is also the vaccine vector utilized in numerous GeoVax vaccines targeting COVID-19, Hemorrhagic fever viruses (e.g., Sudan ebolavirus and Zaire ebolavirus), HIV, Zika and the GeoVax MVA-VLP-MUC1 cancer immunotherapy.  Previous peer-reviewed publications reviewed the successful prevention of Monkeypox in non-human primate models by GeoVax MVA-based HIV vaccines. 

Microcapdaily has been reporting on GOVX for years reporting in july 2020: GeoVax Labs, Inc. (OTCMKTS:GOVX) is on an explosive rise up the charts in recent days running off its $0.50 base and surging over $1 with strength transforming into a volume leader in small caps. David Dodd, Geovax CEO was getting onto fox news regularly earlier this year and this run up too was helped along by his recent appearance on Shannon Bream during which he stated they terminated China connection. LOI not signed and they going it alone.

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Currently trading at a $15 million market valuation GOVX has just 9,449,025 shares outstanding and a healthy balance sheet with just $5 million in liabilities. The Company continues to build up its cash position; in May, GeoVax added to its cash resources through a follow-on offering and private placement of common stock and warrants with net proceeds of approximately $18.5 million, supplementing the $9.2 million raising in January 2022. GeoVax’s cash balances at June 30, 2022 stood at $30.9 million. GOCX is one exciting biotech developing vaccines for the Monkeypox, has a Covid-19 booster candidate, and is working on vaccines for the Ebola, Malaria and Zika viruses. GOVX is also at work on two cancer therapies. The Company is making important progress on several fronts, on the covid vaccine front, the Company’s candidate GEO-CM04S1 shows a lot of promise; analyses of data from the Phase 1 study of GEO-CM04S1 published in the peer-reviewed journal, iScience (accessible here) show that GEO-CM04S1 demonstrated potent and equivalent T-cell cross-reactivity against Delta and Omicron variants. These findings suggest that T-cell immunity stimulated by GEO-CM04S1 may constitute a critical second line of defense to provide long-term protection against SARS-CoV-2 variants. We will be updating on GOVX when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in GOVX either long or short and we have not been compensated for this article.

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