February 20, 2014
VentiRx Pharmaceuticals, Inc. announced the presentation of clinical data of VTX-2337, a cancer immunotherapy, in combination with cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) at the 2014 Multidisciplinary Head and Neck Cancer Symposia inScottsdale, Arizona. Results indicate that the combination of VTX-2337 and cetuximab is well tolerated with no evidence of synergistic toxicities. Encouraging signs of efficacy provided the rationale for the ongoing randomized placebo-controlled Phase 2 study of VTX-2337 in combination with cetuximab, platinum and 5-FU in patients with recurrent or metastatic SCCHN (Active8: NCT01836029). This trial is actively recruiting patients at approximately 50 clinical sites in the United States.
Evidence of the ability of VTX-2337, a Toll-like Receptor 8 (TLR8) agonist, to augment the effect of cetuximab was reported in a Phase 1b investigator-initiated trial conducted with the University of Washington School of Medicine and the Fred Hutchinson Cancer Research Center. The study of twelve patients with advanced SCCHN demonstrated that the combination of VTX-2337 with cetuximab is safe and well-tolerated. Serum biomarkers were consistent with TLR8 activation. Ex-vivo analysis of natural killer (NK) cells collected pre-dose and 24 hours after dosing demonstrated increased NK cell mobilization and activation. This supports the proposed mechanism that VTX-2337 augments the effect of cetuximab by activating NK cells and further stimulating ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) resulting in synergistic anti-tumor activity. All twelve patients were evaluable for tumor response by RECIST 1.1. Two patients (17%) achieved a partial response and 33 percent of patients had a best response of stable disease.
“Given the paucity of treatment options for patients with metastatic SCCHN, targeting the tumor microenvironment with an immunotherapy like VTX-2337 is a promising option for this difficult to treat patient population. The preclinical and early clinical data confirm the potential utility of combining VTX-2337 with cetuximab to enhance anti-tumor activity,” saidRenato Martins, M.D., University of Washington School of Medicine.
“We are encouraged by the positive findings from this trial,” said Robert Hershberg, M.D., Ph.D., President and Chief Executive Officer of VentiRx Pharmaceuticals. “We see a strong scientific and clinical rationale for a monoclonal antibody and immunotherapy combination using our novel TLR8 agonist in this setting. We have committed to study VTX-2337 in a large, randomized, placebo-controlled trial in combination with cetuximab and chemotherapy in the setting of first-line recurrent or metastatic head and neck cancer and are pleased to be actively recruiting patients to this study at leading centers throughout the United States.”
Read the full press release here.