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Designed for immunocompromised patients with severe COVID-19.
ATLANTA, Georgia, Oct. 30, 2023 (GLOBE NEWSWIRE) — NewMediaWire — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines for cancer and infectious diseases, today announced that it has begun planned site expansion for the Phase 2 clinical trial of its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, as the number one vaccine in immunocompromised patients. In addition to finalizing the enrollment of the study at City of Hope Medical Center (Duarte, California). ), the trial will begin enrollment of eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Mass. ) and the Fred Hutchinson Cancer Research Center (Seattle, Washington).
The Phase 2 clinical trial (ClinicalTrials. gov identifier: NCT04977024) compares the protection and immunogenicity of GEO-CM04S1, compared to the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients with hematologic malignancies who received an allogeneic hematopoietic vaccine. Stem cell transplantation, autologous hematopoietic stem cell transplantation, or chimeric antigen receptor (CAR) T-cell therapy. These patients struggle to achieve a good enough protective antibody reaction after receiving the latest COVID-19 vaccines.
David Dodd, President and CEO of GeoVax, commented, “We are excited about site activations to expand the scale and scope of this trial, which we hope will drive patient recruitment for this vital study. in one of the most at-risk patient populations. Lately, they have been underserved for vaccines. We believe that GEO-CM04S1’s exclusive homes potentially offer a more physically potent and longer-lasting degree of coverage than the recently legal COVID-19 vaccines, not only as a vaccine for highly vulnerable immunocompromised patients for whom the newly legal mRNA vaccines may possibly be inadequate, but also potentially for healthy patients as a universal booster shot for mRNA vaccines. In the United States, approximately 15 million people, due to weakened immune systems, do not respond adequately to the newly legal vaccines. It is estimated that there are more than 240 million such patients worldwide. We hope that GEO-CM04S1 will provide physically powerful and long-lasting immune coverage to those patients, while also offering a critically vital option to COVID-19 booster shots for healthy individuals.
A recent publication in Vaccines (https://doi. org/10. 3390/vaccines11091492) of the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing antibody responses, adding neutralizing antibodies, and cellular T responses against ancestral and recently evolving strains of the SARS-CoV-2 virus. They are aware of the progress of the Phase 2 clinical study, which includes a direct comparison with recently approved mRNA vaccines.
About GEO-CM04S1
GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the submission of multiple vaccine antigens to the immune formula in a single dose. GEO-CM04S1 encodes SARS-CoV-2 spike (S) and nucleocapsid (N) antigens and is designed in particular to induce antibody and T-cell responses against parts of the virus that are less likely to mutate over time. The immune formula’s broader functional compromise is designed to protect against severe illness caused by continuously emerging COVID-19 variants. . Vaccines in this format do not require common and repeated modifications or updates.
In addition to this ongoing study, GEO-CM04S1 is being evaluated in two Phase 2 clinical trials:
As a booster shot for healthy patients who in the past received the Pfizer or Moderna mRNA vaccine. ClinicalTrials. gov ID: NCT04639466. GeoVax recently announced that this test is fully registered.
As a booster shot in immunocompromised patients with chronic lymphocytic leukemia (CLL), an organization identified as high-risk for whom existing mRNA vaccines and monoclonal antibody (MAb) treatments appear insufficient to offer protective immunity. ClinicalTrials. gov ID: NCT05672355.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel treatments and vaccines for false tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead oncology program is a novel oncolytic genetic treatment for false tumors, Gedeptin®, which is recently in a multicenter Phase 1/2 clinical trial for complex head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in 3 Phase 2 clinical trials, GEO-CM04S1 is being evaluated as the number one vaccine for immunocompromised patients, such as those with hematologic cancers and other patient populations for whom legal COVID-19 vaccines are ultimately insufficient, and as a booster in patients with chronic lymphocytic leukemia (CLL). Additionally, GEO-CM04S1 is in a Phase 2 clinical trial comparing the vaccine as a more physically potent and long-lasting COVID-19 booster in healthy patients who have already received the mRNA vaccines. GeoVax has a governance team that has driven significant price creation at life sciences corporations over the past few decades. For more information, visit our website: www. geovax. com.
Forward-Looking Statements
This release includes forward-looking statements regarding GeoVax’s business plans. The words “believe”, “expect”, “possibly”, “estimate”, “continue”, “anticipate”, “intend”, “should”, “plan”, “could”, “target”, “potential” , “is likely”, “will”, “expects” and similar expressions, to the extent they apply to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our existing expectations and projections relating to long-term events and monetary trends that we believe could affect our monetary condition, effects of operations, business strategy and monetary needs. The actual effects would possibly differ materially from those included in those statements due to various points, including whether: GeoVax is able To achieve appropriate effects in existing or long-term clinical trials of its investigational products, GeoVax oncology and immunology vaccines can elicit the desired responses, and those products or vaccines can be used well, GeoVax’s generation of viral vectors adequately amplifies the immune responses to cancer antigens, GeoVax can expand and manufacture its oncology products. immuno-oncology and its life-saving vaccines that show the desired characteristics at the right time, GeoVax’s immuno-oncology generation oncology products and life-saving vaccines will be safe for human use, GeoVax vaccines will prevent specific infections in humans, GeoVax Save Youive oncology products and vaccines will obtain the mandatory regulatory approvals to be legal and commercialized, GeoVax will raise the necessary capital to complete its progression. If the progression of competitive products can be more effective or less difficult to use than GeoVax’s products, GeoVax would likely enter into favorable production and distribution agreements, as well as other points over which GeoVax has no control.
More information about our threat points can be found in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statements made by us herein speak only as of the date they are posted. Factors or occasions that can also cause our actual effects to vary might come up from time to time, and it’s not imaginable that we’re expecting them all. We assume no legal responsibility to publicly update any forward-looking information. statements, whether as a result of new data, long-term advancements, or otherwise, unless required by law.
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