Genticel, a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), announces that the company has signed an agreement with Roche Molecular Systems Inc. to evaluate Roche’s cobas HPV Test in preparation for the planned phase 3 trial of GTL001, Genticel’s most advanced therapeutic vaccine candidate against HPV 16/18 infections.
GTL001 is currently being evaluated in a randomized, double-blind phase 2 efficacy study across 7 countries in Western Europe in 236 HPV 16/18 positive patients with normal cytology or minor abnormalities. Interim results are expected early this year with a primary endpoint based on virology. Per protocol, Genticel is using the ISO15189 certified qPCR test from AML, Antwerp, Belgium, a full genotyping test which is also used for the Flemish population based screening program. However, this laboratory-developed test is only performed in Belgium.
In the planned global phase 3 programme of GTL001, Genticel intends to measure the non-appearance of high-grade lesions in HPV 16/18 positive women. For this purpose, the Company requires a more broadly available commercial HPV genotyping test to both identify the patient population at risk prior to enrollment and to assess HPV infection status post-treatment. Therefore, Genticel will assess Roche Molecular Systems’ cobas HPV Test by evaluating existing samples from the phase 2 trial at a clinical virology threshold considered for the global phase 3 program of GTL001.
The cobas HPV Test is currently the only HPV assay which is both EU-labeled and FDA-approved and provides specific genotyping information, notably for HPV 16 and 18, the highest-risk types targeted by GTL001. Since April 2014, the cobas HPV Test is the only test approved in the US that can be used instead of a Pap smear in first-line, primary screening in women 25 years of age and older. Last October, the cobas HPV Test was also awarded the tender as first-line, primary screening test in the National Cervical Cancer Screening Program in the Netherlands. These events further support the continuously growing trend both in Europe and in the US towards early screening for the most dangerous types of HPV and highlight the need for a treatment option for the millions of women infected with HPV 16 or 18 worldwide.
“We are very pleased to enter into this agreement with Roche Molecular Systems,” concluded Benedikt Timmerman, PhD, MBA, chief executive officer of Genticel. “The ability to evaluate the cobas HPV Test is an important milestone that will help us anticipate requirements for the planned phase 3 programme of GTL001 and identify the patient population that will most benefit from treatment.”