Announcement • Aug 25

GeoVax Highlights Positive Phase 3 Results Supporting Gedeptin and Keytruda Combination Strategy

GeoVax Labs, Inc. highlighted positive Phase 3 results reported by Moderna and Merck evaluating intismeran autogene, an individualized neoantigen therapy, in combination with KEYTRUDA (pembrolizumab) as further evidence of an important evolution in cancer immunotherapy directly relevant to GeoVax’s Gedeptin development strategy: combining checkpoint inhibition with complementary approaches designed to generate or enhance anti-tumor immune responses. Moderna-Merck reported that the Phase 3 INTerpath-001 study in patients with completely resected high-risk melanoma met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival. The combination demonstrated statistically significant and clinically meaningful improvements compared with KEYTRUDA alone. The study is continuing to evaluate additional endpoints, including overall survival. For GeoVax, the results have important strategic implications for the planned clinical development of Gedeptin in combination with KEYTRUDA. While Gedeptin and intismeran employ fundamentally different mechanisms, both strategies seek to address a common therapeutic objective: generating or enhancing an anti-tumor immune response that can be amplified by checkpoint inhibition. GeoVax believes the Phase 3 success of intismeran plus KEYTRUDA provides important external clinical validation of this broader combination-treatment paradigm and further reinforces the rationale for advancing Gedeptin in combination with KEYTRUDA. The Moderna-Merck results represent a different therapeutic approach from GeoVax’s investigational Gedeptin therapy. Intismeran is designed to generate an individualized immune response against tumor-specific neoantigens, while Gedeptin utilizes a gene-directed enzyme prodrug therapy (GDEPT) designed to produce potent localized tumor destruction and promote anti-tumor immune activity within the tumor microenvironment. Despite these mechanistic differences, GeoVax believes recent developments increasingly support a broader therapeutic strategy: combining checkpoint inhibition with complementary technologies capable of helping the immune system recognize and attack cancer. Earlier this month, GeoVax highlighted the FDA accelerated approval of Replimune’s TUDRIQEV in combination with nivolumab as another important milestone for tumor-directed therapies used with checkpoint inhibition. Taken together, GeoVax believes these developments illustrate several complementary approaches now converging around a common objective: Personalized immune activation: individualized neoantigen therapies designed to train the immune system to recognize tumor-specific mutations; Tumor-directed immunotherapy: localized approaches designed to destroy tumor cells and stimulate anti-tumor immunity; and Tumor microenvironment priming: strategies designed to help transform immunologically resistant or “cold” tumors into tumors more responsive to checkpoint inhibition. Gedeptin is mechanistically distinct from both individualized cancer vaccines and replication-dependent oncolytic viruses. Gedeptin utilizes a replication-deficient adenoviral vector to deliver the bacterial enzyme purine nucleoside phosphorylase (PNP) directly into tumor tissue. Following administration of fludarabine phosphate, the enzyme converts the inactive prodrug into a potent cytotoxic metabolite within the tumor microenvironment, producing localized tumor destruction with a substantial bystander effect extending beyond directly transduced tumor cells. GeoVax believes Gedeptin’s potential therapeutic value extends beyond localized tumor killing. Recently published research in JCI Insight demonstrated that Gedeptin combined with anti-PD-1 therapy in an immunocompetent preclinical model enhanced anti-tumor immune responses, increased CD8+ T-cell infiltration, generated systemic anti-tumor activity and improved therapeutic outcomes compared with checkpoint inhibition alone. These findings support GeoVax’s strategy of evaluating Gedeptin as a potential tumor-priming therapy designed to make the tumor microenvironment more favorable for checkpoint inhibition. GeoVax is continuing preparations for the next phase of Gedeptin’s clinical development in combination with KEYTRUDA in patients with head and neck squamous cell carcinoma. The planned study is expected to evaluate clinical activity together with biomarkers of immune activation, tumor microenvironment modulation and pathological tumor response, providing an opportunity to investigate whether Gedeptin-mediated tumor priming can enhance response to checkpoint inhibition. Within a matter of weeks, important developments involving fundamentally different technologies but a remarkably consistent therapeutic objective: enable the patient’s immune system to attack cancer more effectively and then leverage checkpoint inhibition to sustain and amplify that response. Gedeptin is GeoVax’s investigational gene-directed enzyme prodrug therapy (GDEPT) for the treatment of solid tumors. The therapy utilizes a replication-deficient adenoviral vector to deliver the bacterial enzyme purine nucleoside phosphorylase (PNP) directly into tumors. Following administration of fludarabine phosphate, the PNP enzyme converts the inactive prodrug into a potent cytotoxic metabolite within the tumor microenvironment, producing localized tumor cell death while promoting anti-tumor immune responses. Gedeptin is being developed in combination with immune checkpoint inhibitors for the treatment of solid tumors.

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