CM04S1 / GeoVax - LARVOL DELTA

Humoral and functional SARS-CoV-2-specific T-cell responses elicited in chronic lymphocytic leukaemia patients with GEO-CM04S1 a synthetic MVA-vectored COVID-19 vaccine. (PubMed, Br J Haematol) - No abstract available

Journal • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Multi-antigen MVA-vectored SARS-CoV-2 vaccine, GEO-CM04S1, induces cross-protective immune responses to ancestral and Omicron variants. (PubMed, Front Immunol) - "Using antibody-mediated depletion, we showed that depletion of CD20 cells or CD8+ T cells did not impact the vaccine protective efficacy whereas depletion of CD4+ T-cells diminished levels of efficacy. Collectively, our data demonstrate the full cross-variant protective immunity induced by GEO-CM04S1 and that CD4+ T-cell responses are a major effector element of vaccine protection."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CD20 • CD4 • CD8

NCI-2020-08335: A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection (clinicaltrials.gov) - P1/2 | N=119 | Active, not recruiting | Sponsor: GeoVax, Inc. | Trial completion date: Jun 2025 ➔ Feb 2026 | Trial primary completion date: Mar 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

Exploring co-infection dynamics and immune response interactions between COVID-19 and Monkeypox: implications for disease severity, viral transmission, and vaccine efficacy. (PubMed, Virol J) - "Global efforts such as adequate awareness campaigns through webinars, social media platforms, and research, including experimental studies, cohort studies, case series, etc., should be put in place to give more insights into both diseases. Such efforts should be backed up with good political will, adequate funding, the establishment of research facilities and interprofessional measures among the concerned countries and policymakers in the world."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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 (EHA 2025) - P2 | "CLL pts who received GEO-CM04S1 COVID19 vaccine generated a more robust T cell response compared with mRNA vaccine recipients. With failure of the mRNA vaccine to meet the primary endpoint, enrollment is now restricted to the Exp arm. While the mRNA vaccine stimulated a more pronounced and sustained humoral immune response, GEO-CM04S1 induced a robust cellular immune response, and thus may be a more effective option for preventing COVID-19 in CLL."

Clinical • IO biomarker • P2 data • Chronic Lymphocytic Leukemia • Cough • Fatigue • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • Respiratory Diseases • CD4 • CD69 • CD8 • IFNG • IL4 • TNFRSF9

GeoVax Announces Upcoming Presentation at the European Hematology Association 2025 Congress Highlighting Positive Immune Response Data for GEO-CM04S1 in CLL Patients (Nasdaq) - "The presentation will highlight initial results from a Phase II randomized clinical trial highlighting the superior cellular immune response of GEO-CM04S1 compared to an authorized mRNA-based COVID-19 vaccine in CLL patients - a population known to exhibit suboptimal protective responses to COVID-19 and other vaccines due to immune dysfunction. The findings will underscore the differentiated mechanism and clinical potential of the GeoVax MVA multi-antigen platform, particularly in immunocompromised individuals."

Chronic Lymphocytic Leukemia • Novel Coronavirus Disease

Immunogenicity of Synthetic MVA-based Vaccine COH04S1 Against SARS-CoV-2 in Post-HCT/CAR-T Patients and Its Cross-Protective Potential Against Mpox (IMMUNOLOGY 2025) - "Immune responses in HCT/CAR-T patients were superior or comparable to those in healthy volunteers (HV) and healthcare workers (HCW) vaccinated with Comirnaty®...In mpox-susceptible mice, COH04S1 and its sMVA backbone protected against lung infection following MPXV challenge. These findings highlight COH04S1's dual potential as a SARS-CoV-2 vaccine for immunocompromised patients and cross-protection against mpox.Keywords: Animals Human Non-Human Primate; Cells T Cells; Infections Viral; Molecules Antibodies"

Clinical • Late-breaking abstract • Hematological Disorders • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • CD4

SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: GeoVax, Inc. | Trial completion date: Mar 2026 ➔ Dec 2027 | Trial primary completion date: Mar 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Respiratory Diseases

NCI-2020-08335: A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection (clinicaltrials.gov) - P1/2 | N=119 | Active, not recruiting | Sponsor: GeoVax, Inc. | Completed ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Jun 2025 | Trial primary completion date: Oct 2023 ➔ Mar 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL13 • IL2 • IL4 • IL6 • TNFA

NCI-2020-08335: A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection (clinicaltrials.gov) - P1/2 | N=119 | Completed | Sponsor: GeoVax, Inc. | Active, not recruiting ➔ Completed | N=189 ➔ 119

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL13 • IL2 • IL4 • IL6 • TNFA

GeoVax Reports 2023 Year-End Financial Results and Provides Business Update (GlobeNewswire) - "GeoVax Labs, Inc...announced its financial results and key operational accomplishments for the year ended December 31, 2023...Initiation of a Phase 2 booster trial targeting immunocompromised patients with chronic lymphocytic leukemia...Results from an interim analysis are anticipated during the first half of 2024....Research and development expenses were $20.7 million for 2023, compared to $9.1 million in 2022, with the increase primarily due to the costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, technology license fees, personnel costs, costs of preclinical research activities and higher travel costs."

Commercial • P2 data • Chronic Lymphocytic Leukemia • Head and Neck Cancer • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Synthetic modified vaccinia Ankara vaccines confer cross-reactive and protective immunity against mpox virus. (PubMed, Commun Med (Lond)) - "These results demonstrate the capacity of sMVA vaccines to elicit cross-reactive and protective orthopox-specific immunity against MPXV, suggesting that COH04S1 and sMVA could be developed as bivalent or monovalent mpox vaccine alternatives against MPXV."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Jan 2024 ➔ Jan 2026 | Trial primary completion date: Jan 2024 ➔ Jan 2026

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Novel Coronavirus Disease • Oncology • IFNG

NCI-2020-08335: A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection (clinicaltrials.gov) - P1/2 | N=189 | Active, not recruiting | Sponsor: GeoVax, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • IL4 • IL6 • TNFA

SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: GeoVax, Inc. | Trial completion date: Jan 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • ACE2 • CD4 • CD8 • IFNG • PD-1 • TNFRSF9

Stimulation of Potent Humoral and Cellular Immunity via Synthetic Dual-Antigen MVA-Based COVID-19 Vaccine COH04S1 in Cancer Patients Post Hematopoietic Cell Transplantation and Cellular Therapy. (PubMed, Vaccines (Basel)) - "Furthermore, both humoral and cellular immune responses in COH04S1-vaccinated HCT/CAR-T patients were superior or comparable to those measured in COH04S1-vaccinated HV or Comirnaty-vaccinated HCW. These results demonstrate robust stimulation of SARS-CoV-2 S- and N-specific immune responses including cross-reactive neutralizing antibodies by COH04S1 in HM patients post HCT/CAR-T, supporting further testing of COH04S1 in immunocompromised populations."

Journal • Hematological Disorders • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Transplantation • CD4

A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Novel Coronavirus Disease • Oncology • IFNG • IL4

GeoVax Announces Initiation of Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia (Bloomberg) - P2 | N=80 | GEO-CM04S1 (NCT05672355) | Sponsor: City of Hope Medical Center | Collaborator: National Cancer Institute (NCI) | "...today announced the start of an investigator-initiated clinical trial...titled 'Randomized observer-blinded phase 2 trial of COVID-19 booster with GEO-CM04S1 or Pfizer-BioNTech Bivalent vaccine in patients with chronic lymphocytic leukemia,' at City of Hope National Medical Center, led by Alexey Danilov, M.D., PhD as principal investigator. GEO-CM04S1, a multi-antigenic SARS-CoV-2 vaccine that targets the spike (S) and nucleocapsid (N) proteins of SARS-CoV-2, is actively under clinical study by GeoVax in severely immunocompromised individuals, as well as in healthy adults for use as a universal heterologous booster."

P2 data

A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: City of Hope Medical Center | Initiation date: Apr 2023 ➔ Sep 2023

Trial initiation date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Novel Coronavirus Disease • Oncology • IFNG • IL4

A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Novel Coronavirus Disease • Oncology • IFNG • IL4