Date: 2016-01-07
Type of information: Collaboration agreement
Compound: cobas® HPV Test
Company: Genticel (France) Roche Molecular Systems
Therapeutic area: Cancer - Oncology - Infectious diseases
Type agreement: collaboration
Action mechanism: 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 U.S. that can be used instead of a Pap smear in first-line,
primary screening in women 25 years of age and older. In October 2015, 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.
Disease:
Details: * On January 7, 2016, Genticel announced that the Company has signed an agreement with Roche Molecular Systems 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 program 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 enrolment 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.
Financial terms:
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