Theriva? Biologics announced a presentation of Phase 1 data from the 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). Encouraging survival was observed in patients progressing to anti-PD(L)-1 agents after systemic VCN-01 in combination with durvalumab.

Data will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress, being held both virtually and in Madrid, Spain from October 20-24, 2023. Key data and conclusions featured in the ESMO presentation include: 20 patients were enrolled with a median of 4 prior lines of therapy, from which six in the concomitant (CS) (single dose of VCN-01 in combination with durvalumab on day 1) and 12 in the sequential (SS) (single dose of VCN-01 on day -14 and durvalumab on day 1) were evaluable for response. In the CS cohort at the 3.3×1012 viral particles (vp) dose, overall survival (OS) was 10.4 months.

In the SS cohort at the 3.3×1012vp dose OS was 15.5 months, whereas in the SS cohort at the 1×1013 vp dose OS was 17.3 months. 11 patients (61.1%) were alive >12 months (2 in CS; 5 in SS at 3.3×1012vp, 4 in SS at 1×1013 vp). In spite of the advanced stage of the disease and objective response rate of 0%, most of the patients appeared to benefit from subsequent treatment.

Biological activity: Patients showed VCN-01 replication 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. Increase of PDL1-CPS (16/21; p=0.013) and CD8 T-cells (12/21; p=0.007) from baseline were found in tumor biopsies.

CPS score of tumor biopsies was increased by administration of VCN-01 at day 8 after administration in the sequential group. A statistical correlation was observed between CPS on day 8 and patient OS (p=0.005).