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

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1 year ago

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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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Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market

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5 days ago

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September 19, 2023

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Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through a private investment round. If all the warrants are cashed in as part of this funding, the total could go up to $26.2 million.

Latest Changes:

Just last week, Aziyo Biologics changed its name to Elutia Inc. Following this change, Elutia made an announcement about selling its Orthobiologics business unit to Berkeley Biologics, a subsidiary of GNI Group Ltd. This move is set to bring in a substantial amount of cash, totalling up to $35 million for Elutia. This sum includes a notable upfront payment of $15 million, plus additional potential earnings of up to $20 million over five years. The deal is expected to be finalized in the fourth quarter of 2023.

This sale is a big step for Elutia, especially in the realm of drug-eluting biomatrix technology (DEB). Elutia is actively seeking approval from the FDA for their main product, CanGaroo RM. This product utilizes innovative biomatrix technology with antibiotics rifampin and minocycline (RM), providing long-term protection for cardiac pacemakers and defibrillators. This tackles a huge market estimated to be worth around 600 million. Elutia is aiming to introduce CanGaroo RM to the market in the first half of 2024.

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Standard Of Care:

Medtronic (NYSE: MDT) stands as the exclusive provider of the antibiotic envelope within the current market. This envelope is crafted using synthetic mesh infused with antibiotics. Back in 2014, Medtronic acquired this technology, making a strategic investment of up to $200 million. Primarily intended for Cardiac Implantable Electronic Device (CIED) revision procedures, this product boasts estimated annual sales in the range of $250 to $300 million.

However, despite its market presence and revenue generation, the Medtronic antibiotic envelope has notable limitations. While it effectively combats infections, its synthetic composition renders it less effective in supporting wound healing. Moreover, it poses challenges in accommodating larger devices like Subcutaneous Implantable Defibrillators (SCID).

Drug-eluting biomatrix (DEB):

Drug-eluting biomatrix (DEB) involves a specialized approach to drug delivery using a biomatrix as a carrier or platform. In simple terms, it’s a technique where a biomaterial matrix, often a biocompatible polymer or similar substance, is used to release drugs in a controlled and targeted manner.

The biomatrix acts as a support structure that can hold and gradually release drugs or therapeutic agents at a specific site in the body, typically over an extended period. This is particularly useful in medical applications where a localized and sustained delivery of medication is necessary.

For instance, in the context of Elutia’s CanGaroo RM, a biomatrix incorporating antibiotics rifampin and minocycline is used to provide prolonged protection for cardiac pacemakers and defibrillators. The biomatrix slowly releases these antibiotics at the surgical site, preventing infections and promoting healing.

DEB technology is gaining traction because it enhances treatment efficiency by ensuring the drug is delivered directly to the target area, minimizing side effects, and optimizing therapeutic outcomes. It’s a promising approach in the field of medical advancements, especially in areas like cardiology, oncology, and orthopedics.

Post-mastectomy Breast Reconstruction:

On top of this, the company also has plans to develop an RM version of its SimpliDerm biomatrix tailored for breast reconstruction procedures. The rate of infections after this surgery is quite high, more than 10%, highlighting a big medical need in a market valued at over $500 million. Elutia is stepping up to address this issue by developing SimpliDerm® RM, which incorporates their unique DEB technology. The funds raised through the private investment round (PIPE) and the sale of the Orthobiologics business unit will not only boost Elutia’s efforts in advancing their drug-eluting biomatrix products for the cardiac pacemaker and defibrillator market, but also for post-mastectomy breast reconstruction.

What’s next:

As mentioned earlier, their biomatrix platform serves two major markets. CanGaroo RM, their upcoming product, is slated for a 1H of 2024 market release and is poised to be a pioneer in a $600 million market. Furthermore, their SimpliDerm RM product utilizes the same proprietary antibiotic-eluting technology found in CanGaroo RM, which serves a 1.6B market according to their presentation deck. They aim to secure an IDE by Q4 2024, and upon achieving these milestones, they plan to venture into neurostimulator markets, particularly in pain management, to further drive their growth.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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ZyVersa Therapeutics’ (NASDAQ: ZVSA) Breakthrough: A Super Tool for Tackling Inflammation in ALS and Beyond

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2 weeks ago

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September 13, 2023

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ZyVersa Therapeutics (NASDAQ: ZVSA) had a spectacular day on the market, with its stock surging by almost 50% following a significant announcement about one of their promising drug candidates, IC-100. This drug is designed to combat inflammation in the context of Inflammatory Diseases, and the latest data is incredibly promising. For those who are new to this field of investment, we’ve taken the liberty of rephrasing the press release in simpler terms.

The Release:

When you’re dealing with diseases like ALS that affect your brain and nerves, shutting down the inflammasome pathway NLRP3 (a multi-protein that regulates the immune system and inflammatory signaling), is not enough.

To address this, ZyVersa is working on something called Inflammasome ASC Inhibitor IC-100. It’s like a super tool designed to block not just NLRP3 but a bunch of other inflammasome pathways too – up to 12 of them. This helps keep inflammation in check, whether it’s in the central nervous system (CNS) or other parts of the body where inflammation is causing problems.

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In a recent paper published in Frontiers in Immunology, they pointed out that focusing only on NLRP3 might not do the trick when it comes to calming CNS inflammation in ALS and similar diseases. They did experiments with cells and even used mice to back up their point. Turns out, just targeting NLRP3 didn’t stop the release of those pesky proinflammatory chemicals or the damage they were causing in the spinal cord.

The authors of the paper basically said, “Maybe we should aim to tackle multiple inflammasome pathways when it comes to diseases like ALS, where lots of inflammasomes are going haywire.”

The CEO and president at ZyVersa, Stephen C. Glover mentioned “Our research shows that to really put the brakes on inflammation driven by multiple inflammasomes, we need more than just NLRP3 inhibition.” He added that IC-100 is like a superhero in the world of inflammation control. It stops the formation of different types of inflammasomes, preventing the start of the inflammation chain reaction, and also puts a halt to something called ASC specks, which keep the inflammation going. You can dive deeper into how IC 100 works by checking out their website here.

So, in plain speak, ZyVersa is cooking up a promising solution for folks dealing with inflammation-related problems, especially those tied to the brain and nerves. They’re not just focusing on one troublemaker; they’re going after a whole gang to keep things under control.

Overall ZyVersa is a company on a mission to create groundbreaking treatments for kidney and inflammatory diseases, and IC-100 could help them in this mission.

We will update you on ZVSA when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Creative Medical Technology NASDAQ: CELZ) Major Breakthrough: Allogeneic Cell Line Paves the Way for Diabetes Treatment

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2 weeks ago

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September 12, 2023

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Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) has recently seen a substantial intraday gain of over 15% in its share price. Despite the absence of any recent news or filings, this surge could suggest significant progress in the realm of allogeneic cell therapy.

Background:

The company is known for its regenerative approaches in various medical areas, including immunotherapy, endocrinology, urology, gynecology, and orthopedics, and made a significant announcement. In the fourth quarter of 2022,They successfully developed a new allogeneic cell line called AlloStem™. AlloStem™ is derived from human perinatal tissue and includes a Master Cell Bank and a Drug Master File. Now, with FDA approval, their program, known as CELZ-201, is being used in an early clinical trial for type 1 diabetes and will continue to be developed for both type 1 and type 2 diabetes treatment.

Additionally, the company is using the AlloStem™ line for its StemSpine® procedure to help treat chronic back pain. They report remarkable results, including over a 90% reduction in narcotic usage, more than an 80% reduction in pain scores, and over a 50% reduction in the Oswestry score in patients treated with AlloStem™.

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Allogeneic Cell Therapy:

Allogeneic Cell Therapy is a treatment that uses cells from healthy donors to treat patients with otherwise untreatable diseases. These cells can come from various sources, like bone marrow, blood, or umbilical cord blood. This approach shows great promise in the medical field.

Allogeneic cell therapy offers potentially curative options for patients when traditional treatments fall short. While still a relatively new field, ongoing research into allogeneic cell therapies holds great potential for patients suffering from these diseases. Companies like Argan Inc. are also exploring the benefits of allogeneic cells.

With FDA approval and ongoing clinical trials, Creative Medical Technology’s recent developments open doors to innovative treatments that could significantly enhance the lives of those dealing with diabetes and other diseases. The global market for allogeneic cell therapy reached $255.6 million in 2022 and is expected to grow at a rate of 27.4% from 2023 to 2030, emphasizing the importance of continued research. As the company remains dedicated to medical innovation, their efforts have the potential to improve the health outcomes of people worldwide.

Latest Release:

The company recently shared key updates on its financial status and drug pipeline for Q3 2023. The biotech company, known for its regenerative medical solutions, reported being debt-free with $14.6 million in cash and $14.4 million in working capital, sufficient to cover expenses through 2024.

Their advancements in treating type 1 diabetes include FDA clearance for a groundbreaking clinical trial using CELZ-201 (AlloStem™). The company obtained Institutional Review Board approval and partnered with Syneos Health for this study. They also filed for Orphan Drug Designation to tackle brittle type 1 diabetes.

Promising results emerged from the CELZ-001 treatment for type 2 diabetes, demonstrating substantial reductions in insulin requirements with no safety concerns.

A pilot study on the StemSpine® procedure, using donor cells (AlloStem), showed impressive reductions in narcotic usage, pain scores, and improved functionality for chronic lower back pain patients.

Creative Medical Technology’s ImmCelz platform proved efficient, requiring fewer donor cells and yielding high-quality results.

They also collaborated with Greenstone Biosciences Inc. to develop a human-induced pluripotent stem cell (iPSC) pipeline, iPScelzTM, aimed at expediting drug discovery. The development of this cell line is expected to save the company two to three years in research and development time, along with associated expenses. Additionally, it will accelerate its drug discovery program by leveraging artificial intelligence.

We will update you on CELZ when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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