Drugs / GEO-CM04S1
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04639466 | Nov 2020 → Oct 2025 | COVID-19 | GeoVax, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04977024 | Sep 2021 → Dec 2026 expected | COVID-19, leukemia, plasma cell myeloma | GeoVax, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2025-12-18 | GeoVax, Inc. | Results GeoVax Announces Publication of Study Demonstrating Cross-Variant Protection Using the Multi-Antigen GEO-CM04S1 Vaccine geovax.com ↗
The study provides definitive preclinical evidence that GeoVax’s multi-antigen COVID-19 vaccine candidate, GEO-CM04S1, delivers full cross-variant protection, driven predominantly by robust T-cell responses, even in the absence of neutralizing antibodies. |
| 2025-12-15 | GeoVax, Inc. | Results GeoVax Announces British Journal of Haematology Publication Highlighting Superior T-Cell Responses of GEO-CM04S1 in CLL Patients geovax.com ↗
GEO-CM04S1 met the study’s primary immunologic endpoint, generating significantly stronger and more durable SARS-CoV-2–specific T-cell responses than BNT162b2 (Pfizer-BioNTech) in patients with chronic lymphocytic leukemia (CLL) |
| 2025-10-16 | GeoVax, Inc. | Results GeoVax Highlights Positive Interim Results for Multi-Antigen COVID-19 Vaccine in Immunocompromised Patients at World Vaccine Congress Europe 2025 geovax.com ↗
Presented Phase 2 data showing GEO-CM04S1 elicits strong T-cell responses to both Spike (S) and Nucleocapsid (N), exceeding responses induced by mRNA boosters. |
| 2025-09-29 | GeoVax, Inc. | Results GeoVax Connects IDSA Guidance on COVID-19 Vaccination for Immunocompromised Patients with Recent Clinical Data for GEO-CM04S1 geovax.com ↗ |
| 2025-09-18 | GeoVax, Inc. | Results GeoVax to Present CM04S1 Clinical Progress at the Emerging Growth Conference geovax.com ↗
Phase 2 data in chronic lymphocytic leukemia (CLL) patients showed that CM04S1 achieved the study’s immune response primary endpoint, while the comparator mRNA vaccine did not. |
| 2025-09-15 | GeoVax, Inc. | Results GeoVax Showcases Positive Phase 2 Data for GEO-CM04S1 in CLL Patients at the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Conference geovax.com ↗
today showcased positive interim results for its lead COVID-19 vaccine candidate, GEO-CM04S1 at the XXI International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2025) in Krakow, Poland. |
| 2025-09-12 | GeoVax, Inc. | Results GeoVax Showcases Promising GEO-CM04S1 Clinical Data at the European Society of Clinical Microbiology and Infectious Disease (ESCMID) Conference geovax.com ↗
GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today discussed positive interim clinical results for its lead COVID-19 vaccine candidate, GEO-CM04S1, presented at the 6th ESCMID Conference on Vaccines in Lisbon, Portugal. |
| 2025-09-08 | GeoVax, Inc. | Results GeoVax to Present Multi-Antigen COVID-19 Vaccine Clinical Data at September International Scientific Conferences geovax.com ↗
GEO-CM04S1 Demonstrates Promise Among Most Vulnerable Immunocompromised Patients |
| 2025-06-17 | GeoVax, Inc. | Results GeoVax Highlights Positive Immune Response Results From GEO-CM04S1 in CLL Patients at the European Hematology Association 2025 Meeting geovax.com ↗
GEO-CM04S1 demonstrated significantly enhanced T cell responses—specifically IFN-γ secretion and activation-induced markers (AIM+)—compared to a matched cohort receiving an authorized mRNA vaccine. |
| 2025-06-10 | GeoVax, Inc. | Results GeoVax Announces Upcoming Presentation at the European Hematology Association 2025 Congress Highlighting Positive Immune Response Data for GEO-CM04S1 in CLL Patients geovax.com ↗
MVA-Based GEO-CM04S1 Vaccine Results in Improved Cellular Immune Response in Patients with Chronic Lymphocytic Leukemia (CLL) Compared with mRNA-Based Vaccine: Initial Results of a Phase II Randomized Study |
| 2025-06-09 | GeoVax, Inc. | Results GeoVax Highlights Broad Cross-Protective Immunity of Multi-Antigen COVID-19 Vaccine Candidates at Keystone Symposia geovax.com ↗
The presentations spotlight the Company’s Modified Vaccinia Ankara (MVA)-vectored COVID-19 vaccine candidates, GEO-CM04S1 and GEO-CM02, and their ability to induce durable, cross-reactive immunity against SARS-CoV-2 variants in preclinical animal models. |
| 2025-06-04 | GeoVax, Inc. | Results GeoVax to Showcase Innovative COVID 19 Vaccine Data at the Keystone Symposia on Vaccinology geovax.com ↗ |
| 2025-05-20 | GeoVax, Inc. | Results GeoVax Reaffirms Urgent Need for Multi-Antigen COVID-19 Vaccines as CDC Shifts Recommendations geovax.com ↗
GEO-CM04S1 delivers broad, durable immunity even in immunocompromised patients—a population estimated at over 40 million adults in the U.S. that are inadequately served by the current authorized, single-antigen mRNA vaccines. |
| 2025-05-08 | GeoVax, Inc. | Results GeoVax Highlights Dual Protective Potential of GEO-CM04S1 Following Presentation at the AAI Annual Meeting 2025 geovax.com ↗
The study in blood cancer/cell transplant patients demonstrated robust, durable, and broad anti-SARS-CoV-2 immune responses following vaccination with COH04S1, including cross-reactive immunity against variants of concern such as Omicron XBB.1.5. |
| 2025-04-24 | GeoVax, Inc. | Results GeoVax Highlights Strong Clinical Results Following Presentation of Multi-Antigen COVID-19 Vaccine at the 25th Annual World Vaccine Congress geovax.com ↗
GEO-CM04S1 demonstrated a significantly higher T cell response rate. |
| 2024-11-19 | GeoVax, Inc. | Results GeoVax Announces Positive Interim Data Review for Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia geovax.com ↗
The outcome of the DSMB interim review appears to support our view of GEO-CM04S1 as a potentially superior COVID-19 vaccine booster within the CLL patient population. |
| 2024-04-04 | GeoVax, Inc. | Results GeoVax Presents Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine geovax.com ↗
The animal studies were designed to characterize the contributions of immune responses to both the S and N and documented the additive effects, which were most evident in the control of disease and the associated lung inflammation and damage. |
| 2024-03-28 | GeoVax, Inc. | Results GeoVax to Present Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine, at the World Vaccine Congress geovax.com ↗
unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. |
| 2024-02-06 | GeoVax, Inc. | Results GeoVax Reports Positive Interim Data from Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster geovax.com ↗
Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway. |
All press releases naming this drug 22 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GEO-CM04S1 | “This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2...” NCT04639466 ↗ |
| Modality | Vaccine | “GEO-CM04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines” NCT04977024 ↗ |
| Route | Intramuscular | “GEO-CM04S1 intramuscularly” NCT04639466 ↗ |