Gedeptin (Ad/PNP) / GeoVax, PNP Therap - LARVOL DELTA

GeoVax Labs, Inc. announced the issuance of U.S. Patent No. 12,453,760 by the United States Patent and Trademark Office, providing composition-of-matter and method-of-use protection for the company’s Gedeptin platform in combination with targeted delivery approaches for solid tumors (City Buzz) - "The patent, which extends through 2045, covers enhanced therapeutic usage of the gene-directed enzyme prodrug therapy across multiple solid tumor types, including head and neck cancer."

Patent • Head and Neck Cancer

GeoVax Expands Gedeptin(R) Development to Additional Solid Tumor Indications (Yahoo Finance) - "GeoVax previously announced updated plans for a Phase 2 clinical trial, AdPNP-203, which will evaluate the addition of intra-tumoral Gedeptin (R) and intravenous fludarabine to recently approved neoadjuvant pembrolizumab as first-line treatment of patients with head and neck squamous cell carcinoma eligible for curative surgery....Trial initiation is planned for the second half of 2026.....GeoVax anticipates early readouts from its preclinical modeling work, with the results supporting the design of potential clinical trials in selected solid tumor indications."

New P2 trial • Preclinical • Squamous Cell Carcinoma of Head and Neck

GeoVax Advances Gedeptin Combination Therapy Following FDA Approval of Keytruda in Head and Neck Cancer (City Buzz) - "The recent FDA approval of Keytruda...supports the potential of GeoVax’s Gedeptin in combination with checkpoint inhibitors like pembrolizumab to improve outcomes for patients with HNSCC....GeoVax is preparing to launch a Phase 2 clinical trial in 2026 to evaluate Gedeptin in combination with a checkpoint inhibitor for patients scheduled for curative-intent surgery. The trial will focus on pathologic response, recurrence rates, and immunologic changes, aiming to enhance local tumor eradication and systemic anti-tumor immunity."

New P2 trial • Squamous Cell Carcinoma of Head and Neck

Viral-vectored, gene-directed prodrug therapy (Gedeptin) in needle-accessible solid tumors (AACR 2025) - "Ad/PNP (Gedeptin®) is a non-replicating adenoviral vector expressing E. coli purine nucleoside phosphorylase (PNP) for intratumoral injection (IT) followed by IV administration of fludarabine (Flu) (Parker, Sorscher. In preclinical studies, Gedeptin/Flu strongly sensitizes tumors to immune checkpoint inhibition (ICI), presumably by destroying tumor tissue locally and exposing neoantigens, enhancing immune response, and promoting activity of ICI. Accordingly, an upcoming Phase II trial will evaluate Gedeptin/Flu/pembrolizumab as neoadjuvant therapy in patients with primarily relapsed squamous cell H&N squamous cell cancer."

IO biomarker • Viral vector • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer (clinicaltrials.gov) - P1/2 | N=10 | Completed | Sponsor: GeoVax, Inc. | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

GeoVax Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Gedeptin on track to advance into Phase 2 clinical trial for first recurrent head and neck cancer in the first half of 2025...This trial is anticipated to be a single-cycle trial in approximately 36 patients with a pathologic response rate as the primary endpoint. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer."

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer (clinicaltrials.gov) - P1/2 | N=8 | Active, not recruiting | Sponsor: GeoVax, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Dec 2024 | Trial primary completion date: May 2024 ➔ Dec 2023

Enrollment closed • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

GeoVax Announces Phase 2 Plans for Gedeptin Cancer Therapy Following Clinical Advisory Committee Review (GlobeNewswire) - "GeoVax Labs, Inc...announced the next steps for the clinical development of its Gedeptin cancer therapy, following a clinical advisory committee review....The primary goal of the planned Phase 2 trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in first-recurrence squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 6 patients with pathologic response rate as the primary endpoint. The Company has initiated the necessary planning activities, including protocol development, manufacturing, and CRO selection with the trial activation anticipated during the first half of 2025."

Clinical protocol • New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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

GeoVax Announces Gedeptin Patient Enrollment Closure for Phase 1/2 Clinical Trial Among Advanced Head and Neck Cancer Patients (GlobeNewswire) - "GeoVax Labs, Inc...today announced the closure of patient enrollment for the Phase 1/2 clinical study evaluating Gedeptin^® in patients suffering from advanced head and neck cancer....'Completion of this trial will be a significant milestone in our Gedeptin clinical development program. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of this year. In the interim, we are in active discussions with advisors on protocol development in support of a follow-on Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal. Our intent is to discuss this follow-on protocol with the FDA, in conjunction with a complete review of the results of the current trial, to ensure alignment with the regulator’s expectations.'"

Clinical protocol • Enrollment closed • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor

GeoVax Presents Gedeptin Clinical Data at the AACR-AHNS Head and Neck Cancer Conference (GeoVax Press Release) - "GeoVax Labs, Inc...announced today the presentation of Phase 1/2 clinical trial data for GeoVax’s gene therapy candidate, Gedeptin^® at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference in Montréal, QC, Canada....No dose limiting toxicities or serious adverse events (SAEs) are definitively attributable to treatment. Additionally, no adverse events above grade 3 severity have been reported. Up to 5 cycles of Gedeptin treatment have been administered without limiting sequelae. Intratumoral expression of the PNP transgene by RT-PCR has been established in treated tumors studied to date. Impairment of tumor growth (i.e., 'stable disease' using RECIST 1.1 evaluation criteria) in targeted lesions was seen in 5 of 7 patients; tumor response assessment in one patient remains under study."

P1/2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: GeoVax, Inc. | Trial completion date: Aug 2024 ➔ Aug 2025 | Trial primary completion date: Aug 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

GeoVax Expands Gedeptin Clinical Research for Advanced Head and Neck Cancers (GlobeNewswire) - "GeoVax Labs, Inc...announced today its clinical trial of Gedeptin® for patients with recurrent head and neck cancers is now actively enrolling patients at three major research centers -- Stanford University, Emory University and Thomas Jefferson University."

Enrollment status • Head and Neck Cancer • Oncology • Solid Tumor