1Q24 Reported With Clinical Milestones Later In FY2024

Vaccine Production Technology Reaches Milestone With Manufacturing Facility Validation

FY2023 Reported With A Review Of Clinical Progress and Upcoming Milestones

Initial Phase 2 Data Shows Immune Responses In COVID-19 Booster Trial

Robert LeBoyer

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Geovax Labs

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Summary.&nbsp;GeoVax presented interim treatment data from its Phase 1/2 trial for Gedeptin at the AACR (American Association for Cancer Research) and AHNS (American Head and Neck Society) joint cancer conference. The results show that the Gedeptin regimen was able to achieve stable disease according to RECIST 1.1 criteria in 5 out of 7 evaluable patients. Biological markers showed expected activity, confirming the mechanism of action.
Study Design and First Data. Gedeptin delivers the PNP gene from E. coli to metabolize a prodrug, fludarabine, into an active cytotoxic drug, fluoroadenine, inside the tumor cells. Patients with refractory head and neck squamous cell carcinoma (HNSCC) can receive up to 5 cycles of the combination, consisting of 3 intratumoral injections of Gedeptin over two days followed by daily infusions of fludarabine for three days. The presentation reported on 8 patients out of the planned 10 patients. Full enrollment is expected by the end of 2Q23.
Intertumoral Expression of PNP Has Been Verified.&nbsp;The Gedeptin regimen met the RECIST 1.1 criteria for Stable Disease (impairment of tumor growth). Tumor sections were tested for PNP gene expression and markers in the steps of its mechanism of action. To test PNP delivery and transgene expression, DNA and mRNA protocols performed on tumor tissue from 5 patients. PNP gene delivery was detected in all tumor samples and every tumor section. Histopathology of over 600 tumor sections is being assessed using 22 immunological markers as part of tissue and mechanistic analysis.&nbsp;
Blood and urine samples from the first 5 patients were tested by PCR to detect the presence of E1a and PNP, indicating the successful delivery and activation of the adenovirus vector and the PNP gene. Expression of PNP gene was detected in all samples except one. Low levels of fluoroadenine were found in blood samples of certain subjects.&nbsp; Determining levels or presence of antibodies against the adenovirus is in progress. Out of the 8 patients, 3 patients have yet to have tissue samples taken for evaluation. 
 
Safety and tolerability.&nbsp;There have been no dose limiting toxicities or serious adverse attributable to the treatment, and no events above Grade 3. This is consistent with the results of a single-dose study reported previously.
Conclusion.&nbsp; The presentation data is a first look at the multi-cycle treatment that could potentially be used in clinical practice.&nbsp; The data shows that Gedeptin can successfully deliver the PNP gene, and that its activation of fludarabine can lead to stable disease.&nbsp; We see this as positive interim data that should allow for a Phase 2 trial in 2024 as expected.&nbsp; We reiterate our Outperform rating and $6 price target.

Geovax Labs (GOVX)

First Gedeptin Data From Phase 1/2 Presented

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1Q24 Reported With Clinical Milestones Later In FY2024 (GOVX)

Vaccine Production Technology Reaches Milestone With Manufacturing Facility Validation (GOVX)

FY2023 Reported With A Review Of Clinical Progress and Upcoming Milestones (GOVX)

Initial Phase 2 Data Shows Immune Responses In COVID-19 Booster Trial (GOVX)

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