Transgene has started dosing patients in a Phase Ib/II clinical trial of TG4001 in combination with avelumab to treat human papillomavirus type 16 positive (HPV-16+) recurrent or metastatic cancers.
TG4001 is Transgene’s active immunotherapeutic currently being developed to express coding sequences of the E6 & E7 tumour-associated antigens of HPV-16 and the IL-2cytokine.
The therapeutic vaccine is based on a non-propagative, attenuated vaccinia vector (MVA).
Designed to leverage adaptive and innate immune systems, avelumab is a human anti-PD-L1 IgG1 monoclonal antibody.
The multi-centre, open-label Phase Ib/II trial will evaluate the safety, tolerability, efficacy and anti-tumour activity of the immunotherapy combination regimen in approximately 50 patients with HPV-16+ cancer such as oropharyngeal squamous cell carcinoma of the head and neck (SCCHN).
The trial is being conducted in alliance with Merck and Pfizer and its first patient has been dosed at the Curie Institute in Paris, France.
Transgene chief medical officer Maud Brandely said: “We believe an immunotherapy combination regimen, such as the combination of TG4001 and avelumab shows significant promise for patients with recurring or resistant advanced HPV-16+ oropharyngeal cancers.”
The Phase Ib part of the trial will investigate the safety of increasing doses of the therapeutic combination in consecutive cohorts with three to six subjects.
During the Phase II part of the trial, efficacy and further assessment of safety of the combination will be carried out in a single arm cohort of patients with HPV-16+ oropharyngeal SCCHN.
Both parts will measure tumour response on local assessments, and patient follow-up will be performed until disease progression, death or the date of data cut-off.
Initial results from the trial are expected to be reported next year.