Trial Begins for First-in-Class Gynecological Cancer Therapy
News Jul 27, 2016
GamaMabs Pharma has announced the first administration to a patient, of GM102, its first-in-class monoclonal antibody (mAb) targeting the anti-Müllerian human receptor II (AMHR2/MISR2) in gynecological cancers. The first administration took place at the Jules Bordet Institute in Brussels, Belgium, as part of a phase Ia/Ib study in AMHR2-positive patients with advanced pre-treated gynecological cancer. The primary objective is to assess the safety of GM102 and to select a dose for future Phase Ib/II trials.
GM102 is a first-in-class mAb, bringing increased tumor cell killing properties through the activation of immune system cells, thanks to its EMABling® glyco-engineering technology.
“We believe that the mechanism of action of GM102 is well suited to gynecological cancers, such as ovarian, endometrium and cervical cancers. It has the potential to improve the treatment of relapsing patients,” said Prof Ahmad Awada, principal investigator of the study at the Jules Bordet Institute.
“As this is the very first time an AMHR2-targeting drug is being tested in oncology patients, we are very excited about generating data that can guide us through the development of GM102 in Phase II. We are extremely pleased with the accrual rate at Jules Bordet, to which French centers will be soon aggregated” said Jean-François Prost, VP R&D at GamaMabs Pharma.
“This is a major milestone for our company after only three years of activity,” said Stéphane Degove, CEO of GamaMabs Pharma.
Following the expected completion in 2017 of the first stage of this dose-escalation study, GamaMabs is planning to initiate a second stage, consisting of two expansion cohorts in gynecological cancers.