Synthetic Biologics Announces Phase I Study To Evaluate The Safety, Tolerability, And Efficacy Of VCN-01 In Combination With Durvalumab In Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma Of The Head And Neck Was Presented At The ESMO Congress

Author: Benzinga Newsdesk | September 12, 2022 08:22am

Key data and conclusions featured in the Poster Presentation include:

 

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Safety: Treatment with VCN-01 had an acceptable safety profile when administered with durvalumab in the sequential regimen (single dose of VCN-01 administered 14 days prior to the first dose of durvalumab; n=14).

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The most common treatment-related adverse events (TRAEs) were pyrexia, flu-like symptoms and increases in liver transaminases.

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TRAEs were dose-dependent, reversible and consistent with TRAEs previously described for other adenovirus-based products.

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Pharmacokinetics (PK) and pharmacodynamics (PD): Based on toxicology and PK/PD analysis the recommended Phase 2 dose is 1x1013 viral particles (vp)/patient.

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Biological activity: Sustained blood levels of VCN-01 viral genomes and increased serum hyaluronidase levels were maintained for over six weeks.

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Observed an increase in CD8 T cells, a marker of tumor inflammation and an upregulation of PD-L1 in tumors.

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Analysis of serial tumor biopsies revealed differential gene expression profiles and downregulation of matrix-related pathways after VCN-01 administration.

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