On September 5, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported a presentation of initial data from a Phase 1 investigator-sponsored study evaluating VCN-01 in combination with durvalumab for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) (Press release, Synthetic Biologics, SEP 5, 2022, View Source [SID1234618995]). Data will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held both virtually and in Paris from September 9-13, 2022.
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"We are encouraged by the acceptable safety profile seen in the sequential arm of this study as well as the biological activity observed in R/M HNSCC patients previously treated with anti-PD(L)-1 agents, which speak to the promise of VCN-01-based combination approaches for devastating cancers with high unmet need," said Manel Cascallό, Ph.D., General Director of Synthetic Biologics’ European Subsidiary. "Further, these results provide valuable dose-finding context and build upon our compelling foundation of data that highlight VCN-01’s differentiated mechanism of action that may transform cancer therapy. We look forward to leveraging our findings as we advance VCN-01 through clinical development and we remain on track to deliver on several value-driving milestones, including the initiation of our Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and our Phase 2/3 study in retinoblastoma in the second half of 2023."
Key data and conclusions featured in the ESMO (Free ESMO Whitepaper) presentation include:
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).
The most common treatment-related adverse events (TRAEs) were pyrexia, flu-like symptoms and increases in liver transaminases.
TRAEs were dose-dependent, reversible and consistent with TRAEs previously described for other adenovirus-based products.
Pharmacokinetics (PK) and pharmacodynamics (PD): Based on toxicology and PK/PD analysis the recommended Phase 2 dose is 1×1013 viral particles (vp)/patient.
Biological activity: Sustained blood levels of VCN-01 viral genomes and increased serum hyaluronidase levels were maintained for over six weeks.
Observed an increase in CD8 T cells, a marker of tumor inflammation and an upregulation of PD-L1 in tumors.
Analysis of serial tumor biopsies revealed differential gene expression profiles and downregulation of matrix-related pathways after VCN-01 administration.
The full abstract (#1231P) is accessible on the ESMO (Free ESMO Whitepaper) Congress portal and the e-Poster will be available on-demand starting Saturday, September 10 at 9:00 a.m. CEST. Additional details of the poster are provided below.
Title: Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M HNSCC)
Presenting Author: Dr. Ricard Mesia (Head of the Medical Oncology Department at Institut Català d’Oncologia- Barcelona, Spain)
Poster Session Date and Time: Monday, September 12 at 12:00 p.m. CEST