In an era of rapid scientific development, the pharmaceutical industry constantly evolves to meet new challenges and seize emerging opportunities. GeoVax, a biotechnology company specializing in developing vaccines against infectious diseases and cancer, is at the forefront of this innovation.
I recently had the opportunity to sit down with David Dodd, CEO of GeoVax, for an enlightening discussion on the company’s unique vaccine development strategy, clinical trials, and approach to serving patient populations often overlooked by conventional vaccines. The conversation sheds light on the company’s specialized focus on immunocompromised patients, their clinical trial operations, and their expectations for the future.
Moe Alsumidaie: Can you elaborate on how GeoVax’s technology differentiates from current vaccines?
David Dodd: GeoVax’s approach to vaccine development is unique. While current vaccines are designed to elicit a strong antibody response, our technology aims for this and more. For instance, related to SARS-CoV-2, we include another part of the virus in our vaccine, the nucleocapsid protein, which is conserved across all coronaviruses. By incorporating this protein in our vaccine, a robust T-cell response occurs. This antibody/T-cell dual-response, intended to provide a more robust, durable immune response mechanism, has been validated and presented at recent conferences such as the World Vaccine Congress and the Vaccine Summit.
Our approach is particularly significant for patients with compromised immune systems, where a strong T-cell response is essential. We intend to differentiate our COVID-19 vaccines by focusing on immunocompromised patients. This cohort broadly includes people with conditions such as sickle cell anemia, renal disease, HIV, and other morbidities that deplete the body from being able to mount an effective response to antibody stimulation.Hence, the critical importance of inducing strong T-cell responses. Currently, we lead the global program in the clinic development of a COVID-19 vaccine that is focused on these high-risk populations.
Alsumidaie: What challenges do you anticipate in running your Phase II studies from a clinical operational standpoint?
Dodd: Clinical trials always present inherent challenges. For example, finding patients to participate in a COVID-19 vaccine trial would be significantly complicated if we were to pursue developing a vaccine for use within the generally healthy population.In other words, as a direct, general competitor to mRNA vaccines. This is because most of these vaccines generally target healthy populations and the vast majority are already vaccinated.
However, our focus is different. We target patient cohorts actively managed by their medical support teams, such as physicians, physician assistants, and nurse practitioners. These include blood cancer patients, whom hematologic oncologists directly manage, and patients with chronic lymphocytic leukemia, for whom current vaccines and monoclonal antibodies are inadequate. Other patient populations, such as those with renal disease, autoimmune diseases such as Lupus, HIV, and others, are actively managed by their medical care teams.
Another trial we’re conducting involves healthy volunteers. In this study, we’re evaluating our vaccine as a potentially more robust, durable booster among patients who have received mRNA vaccines as their initial vaccine. In this health volunteer booster trial, to overcome the challenges of recruiting qualified health volunteers, we work through a network of physicians’ offices that feed into a particular clinical research site.This seems to benefit our patient recruitment process for this more traditional vaccine clinical trial.
Alsumidaie: Can you discuss your strategy for targeting other patient populations like those with HIV or lupus? How does the regulatory approach fit into this?
Dodd: We intend to conduct separate studies for different cohorts. For example, we are conducting a Phase II trial among blood cancer patients and have just announced the initiation of a separate Phase II trial for chronic lymphocytic leukemia patients, evaluating our COVID-19 vaccine compared to an mRNA vaccine. We also have a historical and substantial involvement in the HIV community, having previously developed and advanced an HIV-preventative vaccine. We also have a keen interest in the renal disease population, recognizing the critical need for a safe, effective, and durable COVID-19 vaccine for this population.
In general, we believe that an expedited regulatory process is likely in addressing the various high-risk, immunocompromised populations. We don’t necessarily anticipate that a broad approval, addressing all immunocompromised patients is feasible which is why we’re conducting separate trials
Alsumidaie: The White House recently launched a new initiative to accelerate vaccine development and distribution. How is GeoVax aligning with this initiative, and how will it impact your strategies moving forward?
Dodd: The recent White House Project NextGen initiative aligns perfectly with GeoVax’s mission and strategies. The program is focused on the development of new vaccines and therapeutics to better address SARS-CoV-2 viral strains and to prepare for future strains. Funding for the program is $5 billion, enough to support next-generation vaccines through efficacy testing. We applaud the government’s increased support for vaccine development and distribution. The initiative’s emphasis on innovation, equity, and broad access mirrors our objectives. We are actively participating in this initiative, and anticipate that Project NextGen will bolster our efforts to bring our unique vaccines to as many people as possible as quickly as possible. We look forward to collaborating with other stakeholders in this initiative to achieve a healthier, safer world.
Alsumidaie: What is your projected timeline for bringing these vaccines, as well as your cancer therapy to market?
Dodd: We are data-focused and aim to reach various milestones to move us closer to the market. With support from Project NextGen, we expect to accelerate to completion of our Phase II COVID-19 vaccine program. Also, we believe that an expedited approval process is feasible related to our focus on patients with compromised immune systems. Regarding Gedeptin®, our gene-drug therapy for patients with advanced head and neck cancers, we are concluding the current Phase II/II trial this year, which will be followed by discussions with FDA regarding a regulatory path based on an expanded Phase II trial. If we’re successful, we could have a product available for registration in 2025.
Alsumidaie: How are you managing the company’s stock price, especially with the ongoing scientific developments and the clarifying timeline?
Dodd: Our focus is on reaching certain data milestones. We are in the process of g having a peer-reviewed publication related to initial data from our COVID-19 vaccine in the Phase II program among blood cancer patients. We believe that this update will provide meaningful support for our stock. As we achieve more milestones, this will positively impact our stock price. We also continue to increase our focus and development in oncology, which will be we believe will be of high interest with the investor community.
Alsumidaie: Is there anything else you’d like to share about GeoVax’s strategy or upcoming projects?
Dodd: In the future, we expect to increasingly highlight progress within oncology. This is an area with significant unmet medical needs and our Gedeptin® technology appears to provide multiple opportunities for addressing additional cancers, both through monotherapy, as well as in combination with other therapies such as Immune Checkpoint Inhibitors. We also expect to highly leverage that our COVID-19 vaccine is focused on numerous patient populations dealing with various cancers, providing the opportunity for us to address such medical concerns both relative to their cancers, as well as ensuring more comprehensive care via our COVID-19 vaccine. In summary, we are focused on contributing broadly to improved healthcare for patients worldwide, leveraging our technology and stakeholder relationships. This will include partnering and collaborations to ensure broad access, distribution, and administration of our products worldwide.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and regular contributor to Applied Clinical Trials.
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