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GeoVax Labs announces updates on next generation COVID-19 vaccine » 08:0805/2405/24/23
GeoVax Labs announced the…
GeoVax Labs announced the presentation of updates on the development of its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, including preliminary data from an ongoing Phase 2 clinical trial, during the Vaccines Summit Boston 2023 and the Congress for the International Society for the Advancement of Cytometry, CYTO, 2023 meetings. Each of the presentations included unpublished data from the open-label portion of the Phase 2 trial of CM04S1 in patients undergoing hematological cancer treatment. The preliminary analysis indicated CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies as well as T cell responses. Kelly McKee, M.D., GeoVax's Chief Medical Officer, commented, "These data extend to severely immunocompromised patients our earlier findings in healthy adults that GEO-CM04S1 stimulated a robust, durable, and broad-based humoral and cellular immune response against multiple SARS-CoV-2 variants. Validation of these findings in additional patients with hematologic malignancies, who have received CAR-T and stem cell transplants, is underway as we seek to provide a vaccine solution to those individuals unable to mount adequate protective responses with currently available COVID-19 vaccines."
|Over a week ago|
GeoVax Labs to present vaccine data at upcoming scientific meetings » 09:2705/1505/15/23
GeoVax Labs announced…
GeoVax Labs announced that it will be represented during two upcoming scientific meetings, including Vaccines Summit Boston 2023 in Boston, MA, May 22-24, 2023 and CYTO 2023 in Montreal, Quebec, Canada, May 20-24, 2023. Don Diamond, Ph.D., Professor, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, will deliver a presentation titled, "Assessment of GEO-CM04S1 for Prevention of COVID-19 in Immunocompromised Cell Therapy Patients; An Open-Label Safety Study." Dr. Diamond's presentation will include a description of the development and clinical testing of GeoVax's vaccine candidate, GEO-CM04S1. CM04S1 is a next-generation COVID-19 vaccine based on the use of the MVA viral vector platform, which presents multiple antigens to the immune system to induce both antibody and T cell responses. The vaccine is designed to provide durable protection against new and continually emerging variants of COVID-19, limiting the need for frequent modification and updating. GeoVax is focusing on the clinical development of this vaccine for use in patients with impaired ability to mount adequate protective immune responses to currently available COVID-19 vaccines, to include those with certain malignancies and autoimmune disorders, cell and organ transplant patients, individuals with end-stage kidney disease receiving hemodialysis, and potentially elderly individuals who respond poorly to other vaccines. These individuals may not be able to raise or maintain protective antibody responses following receipt of first-generation mRNA vaccines, contributing to reduced vaccine efficacy. On Tuesday, May 23, Sandra Ortega-Francisco, Ph.D., Department of Hematology and Hematopoietic Cell Transplantation and Hematologic Malignancies Research Institute, City of Hope, will participate in a poster presentation titled, "Induction of multi-antigen specific T cell responses by a synthetic MVA-SARS-CoV-2 vaccine in patients with hematological malignancies."
GeoVax Labs initiated with an Outperform at Noble Capital » 08:1805/0805/08/23
Noble Capital initiated…
Noble Capital initiated coverage of GeoVax Labs with an Outperform rating and $6 price target. Gedeptin, its lead cancer product, is a gene-directed therapy for cancer that uses a proprietary delivery technology to deliver a gene to the cancer cells that converts an inactive prodrug into an active cytotoxic drug within the tumor cells, the analyst tells investors. The firm, which believes company fundamentals have been improving as the environment for small capitalization biotechnology company stocks has been in a long decline, expects the stock to be driven by the clinical milestones in development programs for Gedeptin and CM04S1, a next-generation COVID-19 vaccine.
GeoVax Labs reports Q1 EPS (15c), consensus (20c) » 16:0405/0405/04/23
GeoVax reported cash…
GeoVax reported cash balances of $23,849,860 at March 31 as compared to $27,612,732 at December 31, last year a decrease of $3,762,872. David Dodd, GeoVax's Chairman and CEO, commented, "During the first quarter of 2023, our corporate focus continued to be on the advancement of our ongoing clinical trials for our Gedeptin cancer therapy targeting advanced head and neck cancers and CM04S1, our next-generation SARS-CoV-2 vaccine. Positive initial data was recently presented for CM04S1 during the World Vaccine Congress, and our Gedeptin trial has expanded to additional NCI-designated Cancer Centers, allowing us to accelerate our patient enrollment efforts; we look forward to completing enrollment for this trial in the very near future. I look forward to reporting further progress on each of our ongoing clinical trials during the remainder of the year." Dodd further commented, "In addition to clinical progress, the first quarter was filled with many notable achievements for GeoVax. Significant progress has been made in developing a high-yield, high-capacity, continuous avian cell line system for manufacturing our MVA-based vaccines and immunotherapies, such as CM04S1. We believe this will provide GeoVax the ability to respond to large-scale world needs in a timely manner. Additionally, the recent expansion of our CM04S1 rights to include development for Mpox and smallpox adds to other rights we previously secured from the NIH covering preclinical, clinical and commercial uses of the NIH-MVA, potentially adding significant value to our MVA-based vaccines under development."
|Over a month ago|
GeoVax Labs announces expansion of next-generation vaccine rights » 09:1404/1704/17/23
GeoVax Labs announced the…
GeoVax Labs announced the expansion of its rights under its exclusive license agreement with City of Hope, COH, a world-renowned cancer research and treatment organization, to include development and commercialization rights against orthopoxviruses in addition to SARS-CoV-2. The original license agreement with COH provides GeoVax exclusive worldwide rights to key patents, including the use of COH's proprietary synthetic MVA process, for developing COVID-19 vaccines, including GEO-CM04S1, a multi-antigenic SARS-CoV-2 investigational vaccine expressing the spike and nucleocapsid antigens of the SARS-CoV-2 virus. CM04S1 is currently being studied in two ongoing Phase 2 clinical trials. The amendment to the license announced today grants GeoVax an expanded field of use to develop vaccine products, such as CM04S1, which target the prevention, reduction, amelioration or treatment of COVID-19 to also include targeting the prevention, reduction, amelioration or treatment of diseases caused by a virus within the orthopoxvirus genus. Orthopoxviruses include Mpox, smallpox, and other viruses that cause disease in humans.
GeoVax announces presentation of preliminary data of Covid vaccine candidate » 10:0204/0604/06/23
GeoVax Labs presented an…
GeoVax Labs presented an update on the development of its SARS-CoV-2 vaccine, GEO-CM04S1, including preliminary data from an ongoing Phase 2 clinical trial, during the 23rd Annual World Vaccine Congress taking place in Washington, DC. The presentation, titled "COVID-19 Vaccine CM04S1; A Superior Viral Platform Alternative for Eliciting Durable T Cell Responses in Immunocompromised Hematologic Malignancy Patients," was delivered by Dr. Don Diamond, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating. Diamond's presentation included unpublished data from the open-label portion of the Phase 2 trial of CM04S1 in patients undergoing hematological cancer treatment. The preliminary analysis indicates CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. CM04S1 continues to advance in a second Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population, the company said.
GeoVax Labs presents data from primate studies of Marburg vaccine candidate » 13:3204/0504/05/23
GeoVax Labs announced the…
GeoVax Labs announced the presentation of data from recent nonhuman primate studies of GeoVax's vaccine candidate against Marburg virus, during the 23rd Annual World Vaccine Congress taking place in Washington, DC. The data were presented by Dr. Jason Comer, Associate Professor, Sealy Institute for Vaccine Sciences, University of Texas Medical Branch, in a presentation titled "Preclinical Capabilities at the University of Texas Medical Branch: Evaluating Candidate Vaccines and Immunotherapeutics against Sudan Ebola Virus," during the session on Emerging and Re-Emerging Diseases. Dr. Comer's presentation focused on UTMB's services for regulated, nonclinical studies, and included data from recent studies conducted on behalf of GeoVax. Following encouraging results showing complete protection from Marburg virus challenge in guinea pigs, GeoVax's vaccine efficacy studies targeting Marburg virus and Sudan Ebola virus disease were contracted to UTMB through the National Institute of Allergy and Infectious Disease Preclinical Services. Of particular interest, immunization with GeoVax's vaccine candidate conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected nonhuman primates from viremia, weight loss and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection. The work conducted by UTMB built upon earlier studies demonstrating that guinea pigs vaccinated with GEO-MM01 were 100% protected against death and disease caused by the Angola strain of Marburg virus. The vaccine induced immune responses were characterized by Marburg virus-specific binding and neutralizing antibodies as well as other effector functions like antibody-dependent phagocytosis. The Angola strain is the most virulent strain of Marburg Virus characterized by up to a 90% fatality rate in humans and a successful vaccination approach is of paramount public health importance.
Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations » 09:3803/0303/03/23
CDNA, STLA, PG, RDNT, BILI, ITRI, DPZ, VNO, DEI, POAHY, TTD, ELVN, GOVX, NXT, TOWN
Want to get stock-moving…
GeoVax Labs initiated with a Buy at Dawson James » 07:4603/0303/03/23
Dawson James analyst…
Dawson James analyst Jason Kolbert initiated coverage of GeoVax Labs with a Buy rating and $4 price target. Under the leadership of David Dodd, GeoVax has "transformed itself" and now has "two assets that are worthy of attention," the analyst tells investors. Gedeptin, a gene therapy for solid tumors, is now in Phase 1/2 trials in advanced head and neck squamous cell carcinoma, or HNSCC, and GEO-CM02, a COVID-19 vaccine for immunocompromised patients, the firm said.
GeoVax announces presentation of results from clinical study of HIV therapy » 09:0602/2702/27/23
GeoVax Labs announced the…
GeoVax Labs announced the presentation of results from a clinical study of a combinational HIV therapy that included GeoVax's HIV vaccine candidate, MVA62B. The data were presented at the Conference on Retroviruses and Opportunistic Infections held February 19-22, 2023, in Seattle, Washington. The data were generated, in a clinical trial led by researchers at the University of California, San Francisco, to develop a combinational therapy aimed at reducing or eliminating viral replication in the absence of antiviral medications in HIV-positive individuals. The primary objectives of the proof-of-concept trial were to assess the safety and tolerability of the combinational therapy and to determine the viral load "set-point" during antiviral treatment interruption. Secondary objectives were to assess immune responses and changes in viral reservoir status. The clinical trial was led by Steven Deeks, M.D. of UCSF, a world leader in therapeutic approaches to HIV infections, and was one of the most comprehensive tests to date for the ability of synergistic approaches to control HIV infection. The studies were conducted with funding from amfAR, The Foundation for AIDS Research.