VentiRx begins ACTIVE8 Phase II trial of small molecule Toll-like Receptor 8 agonist

Conducted in 50 centres throughout the US, the study will randomise 175 patients with either VTX-2337 or placebo in combination with cetuximab, platinum and 5-FU chemotherapy.

The primary endpoint is progression-free survival as determined by Immune Related Response Evaluation Criteria in Solid Tumours.

The University of Chicago medicine associate professor and study co-chair Dr Ezra Cohen said the initiation of the trial allows the combination of VTX-2337 with a current standard of care treatment in the first-line setting of recurrent head and neck cancer.

"Given the preclinical and early clinical data with VTX-2337 in SCCHN, we are hopeful that ACTIVE8 will provide meaningful benefits in this population who currently have few treatment options," Cohen added.

The safety of the combination and activation of NK cells subsequent to VTX-2337 dosing was demonstrated in an ongoing Phase I trial in squamous cell carcinoma of the head and neck.

VentiRx president and chief executive officer Robert Hershberg said, "The ACTIVE8 study in head and neck cancer patients focuses on the ability of our novel TLR8 agonist to stimulate NK cells, ADCC and monoclonal antibody responses."

The combination of VTX-2337 with some chemotherapies and monoclonal antibodies in preclinical models demonstrated a synergistic effect in stimulating immune pathways associated with anti-tumour activity.