French-based biotechnology company GamaMabs Pharma has dosed the first patient in the Phase Ia/Ib study of GM102 to treat advanced gynecological cancer.
GM102 is a first-in-class, monoclonal antibody (mAb) targeting the anti-Müllerian human receptor II (AMHR2 / MISR2) characterising gynecological cancers.
It is based on the EMABling glyco-engineering technology, which activates its immune system cells to kill the tumour cells.
The company noted that the first administration of GM102 has taken place at the Jules Bordet Institute in Brussels, Belgium, with AMHR2-positive patients suffering from advanced pre-treated gynecological cancer.
The trial is primarily focused to evaluate the safety in the administration of GM102 and to determine a dose for future Phase Ib/II trials.
GamaMabs Pharma research and development vice-president Jean-François Prost said: “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 centres will be soon aggregated.”
According to principal investigator of the study at the Jules Bordet Institute Ahmad Awada, the mechanism of GM102 can be leveraged to treat gynecological cancers, namely ovarian, endometrium and cervical, and can also improve the treatment of relapsing patients.
The first stage of the Phase Ia/Ib dose escalation study is expected to be completed by next year, following which the company is planning to commence the second stage of the study consisting of two expansion cohorts in gynecological cancers.